42 results on '"Smith EML"'
Search Results
2. Measuring the quality of care related to pain management: a multiple-method approach to instrument development.
- Author
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Beck SL, Towsley GL, Berry PH, Brant JM, and Smith EML
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- 2010
- Full Text
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3. Leadership & professional development. Building a collaboration of hematology-oncology advanced practice nurses, part II: outcomes.
- Author
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Schaal AD, Skalla KA, Mulrooney TJ, Stearns D, and Smith EML
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- 2008
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4. Prazosin as an Adjuvant to Increase Effectiveness of Duloxetine in a Rat Model of Oxaliplatin-Induced Peripheral Neuropathy.
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Wagner MA, Smith EML, Ayyash N, and Holden JE
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- Animals, Rats, Female, Male, Antineoplastic Agents adverse effects, Hyperalgesia drug therapy, Hyperalgesia chemically induced, Hyperalgesia prevention & control, Rats, Sprague-Dawley, Duloxetine Hydrochloride pharmacology, Duloxetine Hydrochloride therapeutic use, Oxaliplatin adverse effects, Peripheral Nervous System Diseases chemically induced, Peripheral Nervous System Diseases drug therapy, Peripheral Nervous System Diseases prevention & control, Disease Models, Animal, Prazosin pharmacology, Prazosin therapeutic use
- Abstract
Objectives: Duloxetine, the only American Society of Clinical Oncology (ASCO) treatment recommended for chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors, is not effective for 40% of survivors. This study examined the ability of a duloxetine-prazosin combination to prevent the development of allodynia and hyperalgesia in a rat model of oxaliplatin-induced peripheral neuropathy (OPIN)., Methods: Female (n = 24) and male (n = 41) rats were started on duloxetine (15 mg), prazosin (2 mg), or a duloxetine-prazosin combination one week prior to administration of the chemotherapy drug, oxaliplatin, and continued the duloxetine-prazosin combination for 32 days. Behavioral testing for mechanical allodynia and mechanical hyperalgesia was done with selected von Frey filaments over the course of the study., Results: Overall percent paw withdrawal for rats that received the duloxetine-prazosin combination was significantly lower in female (p < .001 for both conditions) and male (p = .029 for allodynia; p < .001 for hyperalgesia) than those that received water. No significant posttreatment differences were found for allodynia or hyperalgesia between rats treated with duloxetine and rats that received the duloxetine-prazosin combination in either sex., Conclusions: These finding provide preliminary evidence that a duloxetine-prazosin combination can prevent the posttreatment development of allodynia and hyperalgesia in both male and female rats; however, the results suggest that the duloxetine-prazosin combination is no more efficacious than duloxetine alone in preventing chronic OIPN., Implications for Nursing Practice: The profession of nursing is built on clinical practice supported by scientific research. The current study addressed the clinical practice problem of prevention and management of painful OIPN, which is a priority area in oncology nursing., Competing Interests: Declaration of competing interest The authors declare no potential conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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5. Home-based aerobic exercise feasibility in oxaliplatin-receiving newly-diagnosed cancer survivors.
- Author
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Kanzawa-Lee GA, Larson JL, Resnicow K, Ploutz-Snyder R, Krauss JC, and Smith EML
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- Humans, Female, Male, Middle Aged, Aged, Pilot Projects, Exercise Therapy methods, Motivational Interviewing methods, Antineoplastic Agents, Adult, Walking, Cancer Survivors psychology, Cancer Survivors statistics & numerical data, Feasibility Studies, Gastrointestinal Neoplasms drug therapy, Exercise
- Abstract
Purpose: Physical activity (PA) is beneficial but difficult to maintain during chemotherapy. This pilot RCT explored the feasibility of the MI-Walk intervention-an 8-week motivational enhancement therapy- and home-based brisk walking intervention-among gastrointestinal (GI) cancer survivors receiving chemotherapy., Methods: Sixty stage II-IV GI cancer survivors were recruited from 5 sites at their second infusion visit. Participants were randomized to receive PA education alone or the MI-Walk intervention: motivational enhancement therapy consisting of 3 motivational interviewing and self-efficacy-enhancing counseling sessions, a Fitbit Charge 2, exercise diaries, telephone follow-up, scripted motivational email messages, and optional weekly walking groups., Results: The enrollment and completion rates were 62% and 90%, respectively. The MI-Walk participants (n = 29; mean age = 56.79, SD = 11.72; 97% white; 79% male) reported a baseline moderate-vigorous PA duration of 250.93 (SD = 636.52) min/wk. The mean MI-Walk Intervention acceptability score was 50.32 (SD = 12.02) on a scale of 14-70. Mean Fitbit and counseling helpfulness scores on a 5-point scale were 3.67 (SD = 1.43) and 3.44 (SD = 1.36), respectively. Participants' Fitbit moderate-vigorous PA 8-week averages ranged from 0 to 716.88 min/wk; 64% of participants adhered to ≥127 min/wk. Several characteristics (e.g., age, comorbidity, PA level, employment status, BMI, education level, gender, symptoms) were associated with enrollment, attrition, and intervention acceptability and adherence (p < 0.05)., Conclusion: Enrollment and retention were adequate. The Fitbit and counseling were the most helpful. Acceptability and adherence varied based on participant characteristics; therefore, intervention tailoring and further research among cancer survivors less physically active at baseline and most in need of complex exercise intervention are needed., Clinicaltrials: gov NCT03515356., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Grace Kanzawa-Lee reports financial support was provided by American Cancer Society - Denny Hoelzer Sentinel Technologies Doctoral Scholarship in Cancer Nursing. Grace Kanzawa-Lee reports financial support was provided by The Rita & Alex Hillman Foundation. Grace Kanzawa-Lee reports financial support was provided by University of Michigan Rackham Graduate School. Grace Kanzawa-Lee reports financial support was provided by University of Michigan School of Nursing., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
- Published
- 2024
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6. Parents providing palliative care for children with cancer.
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Rassam RS, Huijer HA, Noureddine S, Smith EML, Wolfe J, Fares S, and Abboud MR
- Abstract
Parents of children with cancer provide paediatric palliative care (PPC). However, the activities they perform remain underexplored, especially in low- and middle-income countries (LMICs) where the care heavily relies on family involvement. The aim of this study is to identify parental PPC tasks and intentions to perform PPC tasks and to determine their associated factors. A quantitative cross-sectional descriptive design was used to recruit parents of children with cancer from three major paediatric oncology centres in Lebanon. Data were collected through structured interviews using an adapted questionnaire. The statistical analyses included descriptive, bivariate and regression analyses of PPC tasks and intentions. One hundred and five participants completed the study. On average, parents performed 22 PPC activities. The findings suggested statistically significant associations of the number of PPC tasks with the participants' marital status, number of people living with the child, the intentions to perform the tasks and the number of the child's symptoms in the previous week. Examining parents' tasks in PPC in LMICs, such as Lebanon, enhances knowledge of PPC practice in these regions and informs improvement strategies. These results promote PPC understanding, highlight factors influencing PPC delivery and provide a useful measure of PPC tasks performed by parents of children with cancer., Competing Interests: The authors declare that there is no conflict of interest. The study was conducted in partial fulfilment of the requirements for the degree of Doctor of Philosophy of the Rafic Hariri School of Nursing at the American University of Beirut., (© the authors; licensee ecancermedicalscience.)
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- 2024
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7. Effectiveness of Duloxetine on Oxaliplatin-induced Allodynia and Hyperalgesia in Rats.
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Wagner MA, Smith EML, Ayyash N, Toledo J, Rasheed Z, and Holden JE
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- Humans, Rats, Male, Female, Animals, Oxaliplatin adverse effects, Duloxetine Hydrochloride adverse effects, Rats, Sprague-Dawley, Hyperalgesia chemically induced, Hyperalgesia drug therapy, Hyperalgesia prevention & control, Antineoplastic Agents adverse effects, Pain, Peripheral Nervous System Diseases
- Abstract
Development of painful oxaliplatin-induced peripheral neuropathy (OIPN) is a major problem in people who receive oxaliplatin as part of cancer treatment. The pain experienced by those with OIPN can be seriously debilitating and lead to discontinuation of an otherwise successful treatment. Duloxetine is currently the only recommended treatment for established painful OIPN recommended by the American Society of Clinical Oncology, but its preventative ability is still not clear. This study examined the ability of duloxetine to prevent signs of chronic OIPN in female (n = 12) and male (n = 21) rats treated with the chemotherapeutic agent oxaliplatin. Using an established model of OIPN, rats were started on duloxetine (15 mg) one week prior to oxaliplatin administration and continued duloxetine for 32 days. Behavioral testing for mechanical allodynia and mechanical hyperalgesia was done with selected von Frey filaments. Significant posttreatment differences were found for allodynia in female ( p = .004), but not male rats. Duloxetine was associated with significant differences for hyperalgesia in both female ( p < .001) and male ( p < .001) rats. These findings provide preliminary evidence of the preventative effects of duloxetine on both oxaliplatin-induced allodynia and hyperalgesia in male and female rats, with a difference noted in response between the sexes., Competing Interests: Declaration of Conflicting InterestsThe authors declare that there is no conflict of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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8. Patient-targeted education (ePRO-E) to increase ePRO intent within an Alliance clinical trial (A221805-SI1).
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Smith EML, Cho Y, Hillman S, Scott MR, Harlos E, Wills R, Loprinzi C, Wilson CM, and Zahrieh D
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- Humans, Surveys and Questionnaires, Intention, Attitude to Computers, Patient Education as Topic, Patient Reported Outcome Measures
- Abstract
Background: The Patient Cloud ePRO app was adopted by the National Cancer Institute National Clinical Trials Network (NCTN) to facilitate capturing electronic patient-reported (ePRO) outcome data, but use has been low. The study objectives were to test whether a patient-targeted ePRO educational resource (ePRO-E) would increase ePRO intent (number of users) and improve data quality (high quality: ≥80% of the required surveys submitted) within an ongoing NCTN study., Methods: The ePRO-E intervention, a patient-targeted educational resource (written material and 6-minute animated YouTube video), was designed to address ePRO barriers. ePRO intent and data quality were compared between 2 groups (N = 69): a historical control group and a prospectively recruited intervention group exposed to ePRO-E. Covariates included technology attitudes, age, sex, education, socioeconomic status, and comorbidity., Results: Intervention group ePRO intent (78.8%) was statistically significantly higher than historical control group intent (47.1%) (P = .03). Patients choosing ePRO versus paper surveys had more positive and higher technology attitudes scores (P = .03). The odds of choosing ePRO were 4.7 times higher (95% Confidence Interval [CI] = 1.2 to 17.8) (P = .02) among intervention group patients and 5.2 times higher (95% CI = 1.3 to 21.6) (P = .02) among patients with high technology attitudes scores, after controlling for covariates. However, the 80% submission rate (percentage submitting ≥80% of required surveys) in the ePRO group (30.6%) was statistically significantly lower than in the paper group (57.9%) (P = .05)., Conclusions: ePRO-E exposure increased ePRO intent. High technology attitudes scores were associated with ePRO selection. Since the ePRO survey submission rate was low, additional strategies are needed to promote high-quality data submission., (© The Author(s) 2024. Published by Oxford University Press.)
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- 2024
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9. Unfolding parental knowledge, attitudes, and beliefs toward palliative care for children with cancer.
- Author
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Rassam RS, Huijer HA, Noureddine S, Smith EML, Wolfe J, Fares S, and Abboud MR
- Abstract
Background: Parents' views toward pediatric palliative care (PPC) remain underexplored, especially in low/middle-income countries where care relies heavily on families. A better understanding of parents' perspectives would inform strategies to support PPC integration into the care of children with cancer. This multicenter study aimed to examine knowledge, attitudes, and beliefs toward PPC among parents of children with cancer in Lebanon to uncover areas for improvement and determine associated factors., Methods: Using a quantitative cross-sectional descriptive design, 105 primary caregivers (RR = 95.4%) were recruited during the child's visit to one of three pediatric oncology centers in Lebanon. Data were collected through structured interviews using questionnaire items newly developed or taken from validated tools. Data were analyzed using descriptive statistics, correlational analysis, and multiple linear regression., Results: Only 18/105 participants (17.1%) had heard about PPC and 2% had accurate information about it. When given a brief description, more than 90% endorsed PPC and recommended its integration upon the child's diagnosis. Respectively, "Religious and spiritual engagement" and "Overwhelming negative emotions" were the most cited facilitators and barriers to integrating PPC. Knowledge, attitudes, and beliefs were significantly associated with several demographic and clinical factors such as education level, number of persons living with the child, child's symptom count, and pain score., Conclusion: This research is among the very first studies conducted to examine parents' perspectives toward PPC for children with cancer in Lebanon. Study findings inform future directions to promote PPC in limited-resource settings through expanded research, policy, education, and practice initiatives., (© 2023 Wiley Periodicals LLC.)
- Published
- 2023
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10. Physical Activity Programming for Older Adults in Assisted Living: Residents' Perspectives.
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Webster KE, Seng JS, Gallagher NA, Gothe NP, Colabianchi N, Smith EML, Ploutz-Snyder R, and Larson JL
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- Humans, Female, Aged, Aged, 80 and over, Male, Exercise, Sedentary Behavior, Motivation, Qualitative Research, Assisted Living Facilities
- Abstract
Decreasing sedentary behavior and increasing light physical activity could promote the maintenance of functional abilities for older adults in assisted living (AL). The purpose of this qualitative study was to gather residents' recommendations about a proposed self-efficacy enhancing intervention to replace sedentary behavior with light physical activity. We interviewed 20 residents (mean age 83.1; 60% women). Topics included their current activities and thoughts about physical activity. We presented the intervention and asked questions to inform its modification. Data were analyzed with content and thematic analysis. Specific recommendations included shorter one-hour sessions and framing the intervention as increasing light physical activity rather than decreasing sedentary behavior. The thematic analysis identified multiple factors that could influence intervention implementation, including motivation to be active, safety concerns, ageist attitudes about physical activity, varying abilities of residents, social influences, and limited opportunities for physical activity. These results will inform physical activity intervention implementation for AL residents.
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- 2023
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11. Comparison of Pre-Diagnosis Physical Activity and Its Correlates between Lung and Other Cancer Patients: Accelerometer Data from the UK Biobank Prospective Cohort.
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Zhou W, Veliz PT, Smith EML, Chen W, Reddy RM, and Larson JL
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- Humans, Male, Cohort Studies, Prospective Studies, Biological Specimen Banks, Exercise, Accelerometry, Lung, United Kingdom epidemiology, Lung Neoplasms diagnosis, Lung Neoplasms epidemiology, Prostatic Neoplasms, Colorectal Neoplasms
- Abstract
Purpose: Physical activity (PA) plays an important role in health outcomes for people with cancer, and pre-diagnosis PA influences PA behaviors after cancer treatment. Less is known about the PA of lung cancer patients, and the strong history of smoking could influence pre-diagnosis levels of PA and place them at risk for health problems. This study aimed to compare pre-diagnosis PA and its correlates in patients with lung cancer and other types of cancer (female breast, colorectal, and prostate cancer) and examine the relationship between pre-diagnosis PA and all-cause mortality. Methods: This study used data from the UK Biobank, which is a national cohort study with accelerometry data. We included 2662 participants and used adjusted linear regressions and survival analyses. Results: Male and female lung cancer groups spent a mean of 78 and 91 min/day in pre-diagnosis moderate to vigorous PA (MVPA), respectively; this is lower than the 3 other types of cancer (p < 0.001). Younger age and faster walking pace had a strong association with PA in all the four types of cancer (p < 0.01). Smoking status had a strong association with PA in the lung cancer group, while obesity had a strong association with PA in female breast, colorectal, and prostate cancer (p < 0.01). Higher levels of pre-diagnosis MVPA (≥1.5 h/day) were associated with a significantly lower all-cause mortality risk. Conclusions: The present study suggests that lung cancer patients are the most inactive population before diagnosis. The identified difference in correlates of PA suggest that cancer-specific approaches are needed in PA research and practices. This study also highlights the importance of high PA for individuals with high cancer risk.
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- 2023
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12. Co-occurrence and metabolic biomarkers of sensory and motor subtypes of peripheral neuropathy from paclitaxel.
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Chen CS, Smith EML, Stringer KA, Henry NL, and Hertz DL
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- Antineoplastic Agents adverse effects, Female, Humans, Prospective Studies, Quality of Life, Breast Neoplasms drug therapy, Paclitaxel adverse effects, Peripheral Nervous System Diseases chemically induced
- Abstract
Purpose: Chemotherapy-induced peripheral neuropathy (CIPN) is the major treatment-limiting toxicity of paclitaxel, which predominantly presents as sensory symptoms, with motor symptoms in some patients. Differentiating CIPN into subtypes has been recommended to direct CIPN research. The objective of this study was to investigate whether sensory and motor CIPN are distinct subtypes with different predictive biomarkers in patients with breast cancer receiving paclitaxel., Methods: Data were from a prospective cohort of 60 patients with breast cancer receiving up to 12 weekly infusions of 80 mg/m
2 paclitaxel (NCT02338115). European Organisation for Research and Treatment of Cancer Quality of Life questionnaire CIPN20 was used to evaluate CIPN. Clusters of the time course of sensory (CIPNS ), motor (CIPNM ), and the difference between sensory and motor (CIPNS -CIPNM ) were identified using k-means clustering on principal component scores. Predictive metabolomic biomarkers of maximum CIPNS and CIPNM were investigated using linear regressions adjusted for baseline CIPN, paclitaxel pharmacokinetics, and body mass index., Results: More sensory than motor CIPN was found (CIPNS change: mean = 10.8, ranged [-3.3, 52.1]; CIPNM change: mean = 3.5, range: [-7.5, 35.0]). Three groups were identified with No CIPN, Mixed CIPN, and Sensory-dominant CIPN (maximum CIPNS : mean = 12.7 vs. 40.9 vs. 74.3, p < 0.001; maximum CIPNM : mean = 5.4 vs. 25.5 vs. 36.1, p < 0.001; average CIPNS -CIPNM : mean = 2.8 vs. 5.8 vs. 24.9, p < 0.001). Biomarkers of motor CIPN were similar to previously identified biomarkers of sensory CIPN, including lower serum histidine (p = 0.029)., Conclusion: Our findings suggest that sensory and motor CIPN co-occur and may not have differentiating metabolic biomarkers. These findings need to be validated in larger cohorts of patients treated with paclitaxel and other neurotoxic agents to determine the optimal approach to predict, prevent, and treat CIPN and improve patients' outcomes., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)- Published
- 2022
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13. Temporal, Location- and Symptom-Specific Likelihood of Patient-Reported Sensory Symptoms Related to Oxaliplatin-Induced Peripheral Neuropathy (OIPN) in Patients Receiving Oxaliplatin for Three Months.
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Zahrieh D, Satele D, Smith EML, Loprinzi CL, and Le-Rademacher J
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While oxaliplatin-induced peripheral neuropathy (OIPN) is more common and severe in patients who receive the previous standard, 6-month oxaliplatin-based treatment, we hypothesized that OIPN was still pervasive in patients who received shorter, 3-month-treatment regimens. Using six EORTC QLQ-CIPN20 questions that quantify numbness (N), tingling (T) and shooting/burning pain (P) in upper/lower distal extremities, our aim is to quantify patient-reported responses over 3 months (6 cycles) of oxaliplatin regarding symptom-specific timing, location and severity. For each question, patients were asked how each of the sensory symptoms had affected them during the preceding week, with 1 = “Not at all”, 2 = “A little”, 3 = “Quite a bit” and 4 = “Very much”. The proportional odds model for the cumulative log odds of response that allowed symptom-specific patient heterogeneity to be obtained was applied to a pooled dataset from the placebo arms of two multisite OIPN prevention trials and fit separately to the upper/lower distal extremities. For each symptom, we report the cycle-specific marginal probabilities for each response. In 141 patients, substantial patient heterogeneity in the likelihood, at a given cycle, of a more severe response for a symptom was present. Distinct patterns in the probabilities for each response over time for N and T were observed between the upper/lower distal extremities, while the probabilities of a response >1 for P was largely negligible in both locations. Despite the decrease in exposure to oxaliplatin from 6 to 3 months, OIPN was still pervasive with patients experiencing considerable N and T in the fingers (or hands) and toes (or feet).
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- 2022
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14. Device-measured sedentary behavior in oldest old adults: A systematic review and meta-analysis.
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Webster KE, Zhou W, Gallagher NA, Smith EML, Gothe NP, Ploutz-Snyder R, Colabianchi N, and Larson JL
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Sedentary behavior contributes to health decline and frailty in older adults, especially the oldest old. The purpose of this systematic review was to synthesize evidence describing the volume of device-measured sedentary behavior and factors that influence sedentary behavior in community-dwelling adults aged 80 and older. Four electronic databases were searched in August 2018; the search was updated in September 2019 and December 2020. Twenty-one articles representing 16 unique datasets from six countries met inclusion criteria. Various devices and data processing methods were used to measure sedentary behavior; the most common device was the ActiGraph accelerometer. Sedentary time during the waking day ranged from 7.6 to 13.4 h/day. Studies using similar measurement methods (hip-worn ActiGraph with uniaxial cut-point <100 counts per minute) had a weighted mean of 10.6 h/day. Subgroup analyses revealed that male gender and age ≥85 may contribute to increased sedentary behavior. Only seven individual articles examined factors that influence sedentary behavior in the 80 and older age group; older age, male gender, non-Hispanic white race/ethnicity, social disadvantage, and declining cognitive function (in men) were associated with increased sedentary behavior. In conclusion, the oldest old are highly sedentary and little is known about factors that influence their sedentary behavior., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 The Authors.)
- Published
- 2021
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15. Development and preliminary testing of the collaboration for leadership and innovation in mentoring survey: An instrument of nursing PhD mentorship quality.
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Smith AB, Umberfield E, Granner JR, Harris M, Liestenfeltz B, Shuman C, and Smith EML
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- Cross-Sectional Studies, Humans, Leadership, Mentors, Pilot Projects, Psychometrics, Reproducibility of Results, Surveys and Questionnaires, Mentoring, Students, Nursing
- Abstract
Background: High-quality PhD nursing student mentorship facilitates student and program success. Extant literature recommends evaluating and improving mentorship to foster optimal PhD student development. However, a comprehensive measure capturing all aspects of mentorship salient to PhD nursing student wellbeing and success is not available., Objectives: The purpose of this pilot study was to develop a new instrument - the Collaboration for Leadership and Innovation in Mentoring (CLIM) - for quantifying important components of PhD student mentorship in nursing, and to preliminarily test its psychometric properties (content validity, sensitivity, test-retest reliability)., Design: The study employed a cross-sectional design., Setting: The CLIM instrument was administered to nursing PhD students at a public state university in the United States., Participants: Sixteen nursing PhD students at various stages in their degree progression completed the instrument., Methods: PhD nursing students developed unique items based on qualitative data collected by the University using an Appreciative Inquiry framework. Seven nursing and non-nursing experts with experience in PhD mentorship evaluated content validity. After revisions, the final 44-item instrument was administered at two time points (one month apart) to allow assessment of test-retest reliability. Test-retest reliability was evaluated using Spearman-rank correlations and data from students with ≥1 year of experience with their mentor., Results: Response rates were 94% for both administrations (n = 16). The instrument's overall Content Validity Index (CVI) was 0.91 (p = 0.05). Test-retest analyses resulted in high correlations (r = 0.91, p < 0.001), further supporting reliability of the CLIM instrument., Conclusions: Preliminary evidence suggests that the CLIM instrument is a reliable instrument of PhD mentorship in nursing. However, additional testing in larger and more diverse graduate student populations is needed to evaluate internal consistency reliability, among other psychometric properties., (Copyright © 2021 Elsevier Ltd. All rights reserved.)
- Published
- 2021
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16. Assessment of Pediatric Chemotherapy-Induced Peripheral Neuropathy Using a New Patient-Reported Outcome Measure: The P-CIN.
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Smith EML, Kuisell C, Kanzawa-Lee G, Bridges CM, Cho Y, Swets J, Renbarger JL, and Gilchrist LS
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- Adolescent, Child, Child, Preschool, Humans, Patient Reported Outcome Measures, Reproducibility of Results, Surveys and Questionnaires, Antineoplastic Agents adverse effects, Neoplasms drug therapy, Peripheral Nervous System Diseases chemically induced, Peripheral Nervous System Diseases diagnosis
- Abstract
Background: Chemotherapy-induced peripheral neuropathy (CIPN) is commonly experienced by children receiving neurotoxic chemotherapy. No validated pediatric CIPN patient-reported outcome (PRO) measures exist. Purpose: To test sensitivity, internal consistency reliability, content and convergent validity, and feasibility of the Pediatric Chemotherapy-Induced Neuropathy (P-CIN), an electronic PRO measure for assessing CIPN in children who received neurotoxic chemotherapy. Method: Five experts evaluated content validity of the 14-item P-CIN. Children 5 to 17 years old with CIPN ( N = 79) completed the P-CIN via tablet computer; a subset ( n = 26) also underwent neurological examinations using the Pediatric-Modified Total Neuropathy Score. Following preliminary analyses, one item was deleted and three others modified. The revised P-CIN was retested with patients ( n = 6) who also completed the Bruininks-Oseretsky Test of Motor Proficiency motor function assessment. Means, item response ranges, standard deviations, content validity indexes, Cronbach's alphas, and correlation coefficients were calculated. Results: Mean participant age was 11.25 ( SD = 4.0) years. Most had acute leukemia (62.5%) and received vincristine (98.7%). Content validity index coefficients ranged from .80 to 1.0 ( p = .05). For 9 of 14 items, responses ranged from 0 to 4 or 5; response ranges for toe numbness, pick up a coin, and three of four pain items were 0 to 3. After deleting one item, Cronbach's alpha coefficient was .83. P-CIN scores were strongly associated with Pediatric-Modified Total Neuropathy Score ( r = .52, p < .01) and Bruininks-Oseretsky Test of Motor Proficiency ( r = -.83, p = .04) scores. Sixty-eight percent of children 6 to 17 years old completed P-CIN independently. Discussion: Preliminary evidence suggests that the 13-item P-CIN is internally consistent, is valid, and can be completed independently by children ≥ 6 years. However, we recommend additional testing.
- Published
- 2021
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17. Characteristics and patterns of pediatric chemotherapy-induced peripheral neuropathy: A systematic review.
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Smith EML, Kuisell C, Cho Y, Kanzawa-Lee GA, Gilchrist LS, Park SB, Scott MR, and Alberti P
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- Child, Humans, Antineoplastic Agents adverse effects, Peripheral Nervous System Diseases chemically induced
- Abstract
This systematic review provides a high-quality synthesis of the empirical evidence regarding chemotherapy-induced peripheral neuropathy (CIPN) characteristics and patterns described in studies of children who received neurotoxic chemotherapy to treat cancer. PubMed, CINAHL, PsycINFO, and Embase were searched for articles published 2009 - 2019, yielding 861. Forty-two papers met the eligibility criteria, including 31 that described characteristics and patterns of vincristine-induced CIPN. Fifty-seven percent of articles were of low to moderate quality; measurement flaws were the most common limitations. The reported CIPN incidence varies widely (2.8%-100%) depending on risk factors (e.g., race) and the measurement approach. Incidence rates of sensory, motor, autonomic CIPN, and pain were 12-28%, 50-72%, 0.8-83% and 5.7-44%, respectively. The evidence suggests that sensory and motor neuropathy, pain, and functional deficits are common and can persist into adulthood. Caucasian race is a risk factor and, contrary to prior thinking, cumulative chemotherapy dosage alone does not predict CIPN severity. The influence of other risk factors is less clear, and studies to date have not explored potential interactions among race, genetics, age, sex, drug metabolism, and nutritional status, among other factors., (Copyright © 2021. Published by Elsevier Ltd.)
- Published
- 2021
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18. Obesity as a Potential Risk Factor for Vincristine-induced Peripheral Neuropathy.
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Sajdyk TJ, Boyle FA, Foran KS, Tong Y, Pandya P, Smith EML, Ho RH, Wells E, and Renbarger JL
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- Adolescent, Child, Child, Preschool, Female, Humans, Male, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma complications, Risk Factors, Antineoplastic Agents, Phytogenic adverse effects, Obesity complications, Peripheral Nervous System Diseases chemically induced, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma drug therapy, Vincristine adverse effects
- Abstract
Acute lymphoblastic leukemia (ALL) is the most common pediatric cancer. Vincristine is a core chemotherapeutic agent for patients with ALL; unfortunately, ∼78% will develop vincristine-induced peripheral neuropathy (VIPN). VIPN can result in vincristine dose reductions that decrease therapeutic efficacy: making it important to understand which children are at highest risk for VIPN. We hypothesized that pediatric ALL patients who were obese at diagnosis would develop worse VIPN than healthy weight children with ALL within the first year. Our results confirmed that obese pediatric patients have significantly (P=0.03) worse VIPN than patients of healthy weight.
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- 2020
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19. Patient factors associated with discrepancies between patient-reported and clinician-documented peripheral neuropathy in women with breast cancer receiving paclitaxel: A pilot study.
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Salgado TM, Liu J, Reed HL, Quinn CS, Syverson JG, Le-Rademacher J, Lopez CL, Beutler AS, Loprinzi CL, Vangipuram K, Smith EML, Henry NL, Farris KB, and Hertz DL
- Subjects
- Adult, Aged, Electronic Health Records statistics & numerical data, Female, Health Literacy statistics & numerical data, Humans, Middle Aged, Pilot Projects, Socioeconomic Factors, Trust psychology, Antineoplastic Agents adverse effects, Breast Neoplasms drug therapy, Breast Neoplasms psychology, Paclitaxel adverse effects, Patient Reported Outcome Measures, Peripheral Nervous System Diseases chemically induced
- Abstract
Purpose: Discrepancies between clinicians' assessment of chemotherapy-induced peripheral neuropathy (CIPN) and patient-reported outcomes (PRO) have been described, though the underlying reasons are unknown. Our objective was to identify potential patient-specific factors associated with under-describing of CIPN to clinicians in women with non-metastatic breast cancer treated with paclitaxel., Methods: Patients enrolled in an observational study (n = 60) completed weekly CIPN PRO using the EORTC CIPN20. Clinician-documented CIPN using the NCI CTCAE were abstracted from the electronic medical record and paired with CIPN20 data at weeks 7 and 10. Patients were classified as under-describers if their CIPN20 was above the 80th percentile of the CIPN20 distribution for that CTCAE grade from an independent clinical trial (N08CA). Demographics, Assessment of Survivor Concerns (ASC), Trust in Oncologist Scale (TiOS), and health literacy assessment were collected post-treatment via survey. Repeated measures cumulative logistic regression models were used to identify factors associated with under-describing CIPN., Results: Forty-two women completed the survey (response rate 70%). Three and 9 patients were categorized as under-describers at weeks 7 and 10, respectively. Women who were not working (OR = 9.00, 95%CI 1.06-76.15), had lower income (OR = 7.04, 95%CI 1.5-32.99), and displayed higher trust in their oncologist's competence (OR = 1.29, 95%CI 1.03-1.62 for a 0.1-unit increase in score) were more likely to under-describe CIPN symptoms., Conclusions: This preliminary study identified non-working status, low income and trust in oncologist's competence as potential factors influencing under-description of CIPN to the clinical team. Further work is needed to clarify these relationships and test additional factors., Competing Interests: Declaration of competing interest Syverson owns stock in Pfizer Inc. and AbbVie Inc. Loprinzi received personal fees from Pled Pharma, Metys, Disarm Therapeutics, and Asahi Kasei. Farris is a consultant and received remuneration from Quio Technologies. All other authors declare that they have no conflict of interest., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2020
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20. Exercise Effects on Chemotherapy-Induced Peripheral Neuropathy: A Comprehensive Integrative Review.
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Kanzawa-Lee GA, Larson JL, Resnicow K, and Smith EML
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- Antineoplastic Agents adverse effects, Humans, Randomized Controlled Trials as Topic, Treatment Outcome, Exercise Therapy, Peripheral Nervous System Diseases chemically induced, Peripheral Nervous System Diseases therapy
- Abstract
Background: No effective cures for chemotherapy-induced peripheral neuropathy (CIPN) are known; however, exercise may be beneficial., Objective: The purpose of this review was to synthesize high-quality research publications reporting the effects of exercise on CIPN and related outcomes among people of all age groups who received neurotoxic chemotherapy., Methods: PubMed, CINAHL, Scopus, PsycINFO, and SPORTDiscus databases were searched first between May and November 2016 and then again in April 2019 for all clinical trials and meta-analyses. Subsequent hand-searching continued through April 2019. Potential scientific bias was rigorously evaluated, using the CONSORT (Consolidated Standards of Reporting Trials) guidelines., Results: Thirteen studies (7 randomized controlled trials, 6 quasi-experiments) were found that reported exercise effects in various adult CIPN populations (ie, mixed cancer types and stages, chemotherapy regimens and status, and CIPN presence and severity). No studies provided high-quality evidence; 2 studies provided moderate-quality evidence. Most studies (76.3%) evaluated combined aerobic, strength, and balance training interventions of varying dosages. The most commonly improved outcomes were CIPN, balance, and fitness. All 7 studies with an aerobic exercise component led to significant-most studies showing moderate to large-CIPN benefits., Conclusions: Few studies-none of high quality or in child/adolescent populations-have evaluated exercise effects on CIPN. The exercise interventions, dosages, and settings have been too heterogeneous to identify the most beneficial intervention for other CIPN-related outcomes. However, aerobic exercise may be a key component of exercise interventions for CIPN., Implications for Practice: Although promising, the empirical evidence is insufficient to definitively conclude that exercise interventions ameliorate CIPN.
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- 2020
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21. Genetic variation in EPHA contributes to sensitivity to paclitaxel-induced peripheral neuropathy.
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Marcath LA, Kidwell KM, Vangipuram K, Gersch CL, Rae JM, Burness ML, Griggs JJ, Van Poznak C, Hayes DF, Smith EML, Henry NL, Beutler AS, and Hertz DL
- Subjects
- Biomarkers, Female, Genetic Variation, Humans, Antineoplastic Agents, Phytogenic adverse effects, Breast Neoplasms, Paclitaxel adverse effects, Peripheral Nervous System Diseases chemically induced, Peripheral Nervous System Diseases genetics, Receptors, Eph Family genetics
- Abstract
Aims: Chemotherapy-induced peripheral neuropathy (PN) is a treatment limiting toxicity of paclitaxel. We evaluated if EPHA genetic variation (EPHA4, EPHA5, EPHA6, and EPHA8) is associated with PN sensitivity by accounting for variability in systemic paclitaxel exposure (time above threshold)., Methods: Germline DNA from 60 patients with breast cancer was sequenced. PN was measured using the 8-item sensory subscale (CIPN8) of the patient-reported CIPN20. Associations for 3 genetic models were tested by incorporating genetics into previously published PN prediction models integrating measured paclitaxel exposure and cumulative treatment. Significant associations were then tested for association with PN-related treatment disruption., Results: EPHA5 rs7349683 (minor allele frequency = 0.32) was associated with increased PN sensitivity (β-coefficient = 0.39, 95% confidence interval 0.11-0.67, p = 0.007). Setting a maximum tolerable threshold of CIPN8 = 30, optimal paclitaxel exposure target is shorter for rs7349683 homozygous (11.6 h) than heterozygous (12.6 h) or wild-type (13.6 h) patients. Total number of missense variants (median = 0, range 0-2) was associated with decreased PN sensitivity (β-coefficient: -0.42, 95% confidence interval -0.72 to -0.12, P = .006). No association with treatment disruption was detected for the total number of missense variants or rs7349683., Conclusion: Isolating toxicity sensitivity by accounting for exposure is a novel approach, and rs7349683 represents a promising marker for PN sensitivity that may be used to individualize paclitaxel treatment., (© 2019 The British Pharmacological Society.)
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- 2020
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22. Approaches to measure paediatric chemotherapy-induced peripheral neurotoxicity: a systematic review.
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Smith EML, Kuisell C, Kanzawa-Lee GA, Bridges CM, Alberti P, Cavaletti G, Saad R, and Park S
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- Child, Humans, Neurotoxicity Syndromes diagnosis, Pediatrics, Peripheral Nervous System Diseases diagnosis, Antineoplastic Agents adverse effects, Neoplasms drug therapy, Neurotoxicity Syndromes etiology, Peripheral Nervous System Diseases chemically induced
- Abstract
In children who receive neurotoxic chemotherapy, peripheral neurotoxicity occurs frequently, necessitates dose reduction or treatment cessation, and affects function and long-term quality of life. No treatments exist for peripheral neurotoxicity and few assessment measures are specific to children. We did a systematic review to analyse the published literature concerning the evaluation of assessment measures for paediatric chemotherapy-induced peripheral neurotoxicity. We searched PubMed, CINAHL, PsycINFO, and Embase on Nov 7-8, 2018; of 1409 articles, seven met the inclusion criteria. A total of 335 children (excluding ten healthy controls) were enrolled in the seven studies and the sample sizes ranged from 17 to 86 individuals. 276 (82%) of the 335 children were actively undergoing chemotherapy treatment. Most studies did not comprehensively evaluate the psychometric properties of assessment measures for chemotherapy-induced peripheral neurotoxicity. By use of a narrative analysis that combined approaches from the Joanna Briggs Institute (Adelaide, SA, Australia) and the quality of diagnostic accuracy studies assessment method (known as QUADAS), only one study was deemed high quality. We identified two variants of the Total Neuropathy Score, two grading scales, two semi-objective tests, one patient-reported outcome, and several mobility measures. The National Cancer Institute Common Terminology Criteria for Adverse Events and the Balis grading scales showed lower sensitivity and specificity than the items of the Total Neuropathy Score. Although there is insufficient evidence to support the use of most approaches to assess chemotherapy-induced peripheral neurotoxicity in children, two variants of the Total Neuropathy Score, the pediatric-modified Total Neuropathy Score and the Total Neuropathy Score-pediatric vincristine, are promising but require further testing. Other approaches are less sensitive or less feasible. A patient-reported outcome measure for chemotherapy-induced peripheral neurotoxicity in children is needed., (Copyright © 2020 Elsevier Ltd. All rights reserved.)
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- 2020
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23. Vitamin D deficiency increases severity of paclitaxel-induced peripheral neuropathy.
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Jennaro TS, Fang F, Kidwell KM, Smith EML, Vangipuram K, Burness ML, Griggs JJ, Van Poznak C, Hayes DF, Henry NL, and Hertz DL
- Subjects
- Adult, Aged, Antineoplastic Agents, Phytogenic adverse effects, Breast Neoplasms pathology, Female, Follow-Up Studies, Humans, Middle Aged, Peripheral Nervous System Diseases etiology, Prognosis, Prospective Studies, Retrospective Studies, Breast Neoplasms drug therapy, Paclitaxel adverse effects, Peripheral Nervous System Diseases pathology, Severity of Illness Index, Vitamin D Deficiency complications
- Abstract
Purpose: Approximately 25% of patients receiving weekly paclitaxel for breast cancer require treatment disruptions to avoid severe, irreversible peripheral neuropathy (PN). Vitamin insufficiencies are PN risk factors in many diseases, but their relevance to chemotherapy-induced PN is unknown., Methods: We investigated whether baseline insufficiency of vitamin D, vitamin B12, folate, or homocysteine increased PN in patients with breast cancer receiving weekly paclitaxel in a retrospective analysis of a prospective observational study. Patient-reported PN was collected at baseline and during treatment on the Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (CIPN20). The primary analysis tested associations between vitamin deficiency and the maximum increase from baseline in the CIPN20 sensory subscale (ΔCIPN8). Secondary analyses tested for association with PN-induced treatment disruptions and adjusted associations for treatment and clinical variables., Results: 25-hydroxy-vitamin D was the only nutrient with sufficient deficiency (< 20 ng/mL) for analysis (15/37 = 41%). Vitamin D-deficient patients had a greater mean PN increase than non-deficient patients (ΔCIPN8 ± SD, 36 ± 23 vs. 16 ± 16, p = 0.003) and a non-significant, approximately threefold increase in risk of treatment disruption (OR 2.98, 95% CI [0.72, 12.34], p = 0.16). In multivariable models adjusted for clinical and treatment variables, baseline vitamin D level was inversely associated with PN (β = - 0.04, p = 0.02)., Conclusion: Pre-treatment vitamin D deficiency was associated with PN in women receiving weekly paclitaxel for breast cancer. Vitamin D deficiency may be an easily detected PN risk factor that could be resolved prior to treatment to prevent PN, avoid treatment disruptions, and improve treatment outcomes.
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- 2020
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24. Characterization of Internal Validity Threats to Phase III Clinical Trials for Chemotherapy-Induced Peripheral Neuropathy Management: A Systematic Review.
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Lee D, Kanzawa-Lee G, Knoerl R, Wyatt G, and Smith EML
- Abstract
Objective: The recent American Society of Clinical Oncology (ASCO) Clinical Guidelines for chemotherapy-induced peripheral neuropathy (CIPN) management (48 Phase III trials reviewed) only recommend duloxetine. However, before concluding that a CIPN intervention is ineffective, scientists and clinicians should consider the risk of Type II error in Phase III studies. The purpose of this systematic review was to characterize internal threats to validity in Phase III CIPN management trials., Methods: The PubMed, CINAHL, EMBASE
® , and Scopus databases were searched for Phase III clinical trials testing interventions for CIPN management between 1990 and 2018. The key search terms were neoplasms, cancer, neuropathy, and CIPN. Two independent researchers evaluated 24 studies, using a modified Joanna Briggs Institute Checklist for Randomized Control Trials developed by the authors specific for CIPN intervention trials., Results: Two studies exhibited minimal or no design flaws. 22/24 Phase III clinical trials for CIPN have two or greater design flaws due to sample heterogeneity, malapropos mechanism of action, malapropos intervention dose, malapropos timing of the outcome measurement, confounding variables, lack of a valid and reliable measurement, and suboptimal statistical validity., Conclusions: Numerous CIPN interventions have been declared ineffective based on the results of Phase III trials. However, internal validity threats to numerous studies may have resulted in Type II error and subsequent dismissal of a potentially effective intervention. Patients may benefit from rigorous retesting of several agents (e.g., alpha-lipoic acid, duloxetine, gabapentin, glutathione, goshajinkigan, lamotrigine, nortriptyline, venlafaxine, and Vitamin E) to expand and validate the evidence regarding ASCO's recommendations for CIPN management., Competing Interests: There are no conflicts of interest., (Copyright: © 2019 Ann & Joshua Medical Publishing Co. Ltd.)- Published
- 2019
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25. Implementation of a Survivorship Care Plan Program in a Community-Based Oncology Clinic.
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Soulia SL, Duffy EA, Morley KA, and Smith EML
- Abstract
There is conflicting evidence from the small number of randomized controlled trials (RCTs) that have assessed the benefit of survivorship care plans (SCPs) on improving patient outcomes. Yet, published quasi-experimental and descriptive studies provide preliminary evidence suggesting that using survivorship care plans in practice may improve patient knowledge, decrease worry and anxiety, and lead to patient and primary care physician satisfaction. Given the conflicting evidence and the paucity of RCTs, further research is needed to more fully explore the effect of SCP on patient outcomes. To address this knowledge gap, an SCP program was implemented in a community-based oncology clinic and used quality improvement methodology to assess the effect on patient knowledge of diagnosis, treatment, and follow-up, and to understand patients' satisfaction with the current SCP program. A total of 30 cancer patients were recruited in Southeast Michigan to participate in an SCP quality improvement project and completed surveys to evaluate the SCP program. Data were collected between December 2017 and March 2018. We observed a statistically significant ( p = .028) difference between pre- and postintervention (survivorship care plan visit) knowledge scores about cancer diagnosis, treatment received, and follow-up recommendations. Moreover, participants were satisfied with the survivorship care plan and visit., Competing Interests: The authors have no potential conflicts of interest to disclose., (© 2019 Harborside™.)
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- 2019
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26. Characterizing patient-clinician chemotherapy-induced peripheral neuropathy assessment and management communication approaches.
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Knoerl R, Smith EML, Han A, Doe A, Scott K, and Berry DL
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- Adult, Aged, Aged, 80 and over, Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Quality of Life, Antineoplastic Agents adverse effects, Communication, Peripheral Nervous System Diseases chemically induced, Peripheral Nervous System Diseases therapy, Physician-Patient Relations
- Abstract
Objective: To describe the frequency and characteristics of chemotherapy-induced peripheral neuropathy (CIPN) assessment and management communication approaches between patients receiving neurotoxic chemotherapy and clinicians., Methods: The data used in this analysis originated from a randomized controlled trial in which adults with cancer self-reported treatment-related symptoms using web-based symptom assessment technology. Three-to-six weeks after study initiation, each participant's outpatient visit was audio-recorded. Audio recordings and associated clinician notes for 159 participants who received platinum and/or taxane-based chemotherapy were coded for the presence of several CIPN assessment and management communication characteristics., Results: Participants received low cumulative neurotoxic chemotherapy doses (75%) at the time of audio recording. CIPN was discussed and documented in 44% and 46% of participant-clinician encounters. In symptomatic participants, clinicians asked an average of 0.7 open-ended questions, appropriately managed 70% of cases, and asked upper and lower extremity CIPN questions in 25% of cases., Conclusions: Clinicians infrequently discussed and documented CIPN in participants with low CIPN severity, however appropriately managed mild CIPN. Development of interventions to translate existing recommended CIPN communication approaches into practice are required., Practice Implications: Effective participant-clinician communication is required at each clinic visit during chemotherapy treatment to identify initial signs of CIPN and offer appropriate treatment., (Copyright © 2019 Elsevier B.V. All rights reserved.)
- Published
- 2019
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27. Pharmacologic Treatments for Chronic Cancer-Related Pain: Does Anything Work?
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Smith EML
- Subjects
- Bayes Theorem, Humans, Network Meta-Analysis, Cancer Pain, Chronic Pain
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- 2019
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28. Rasch model-based testing of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) using Alliance for Clinical Trials in Oncology (Alliance) A151408 study data.
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Smith EML, Zanville N, Kanzawa-Lee G, Donohoe C, Bridges C, Loprinzi C, Le-Rademacher J, and Yang JJ
- Subjects
- Adult, Aged, Aged, 80 and over, Cluster Analysis, Female, Humans, Male, Middle Aged, Models, Theoretical, Peripheral Nervous System Diseases drug therapy, Psychometrics standards, Quality of Life, Randomized Controlled Trials as Topic, Surveys and Questionnaires, Young Adult, Antineoplastic Agents adverse effects, Neoplasms drug therapy, Peripheral Nervous System Diseases chemically induced, Psychometrics methods
- Abstract
Purpose: To test the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) using Rasch-based methods., Methods: A secondary data analysis was performed using pooled QLQ-CIPN20 data from patients (N = 1008) who had participated in any of four multi-site chemotherapy-induced peripheral neuropathy (CIPN) treatment and prevention trials. QLQ-CIPN20 responses were evaluated using a polytomous Rasch partial credit model. Data were assessed for person-item fit using the chi-square statistic, item scaling based on response proportions, threshold ordering using item characteristic curves and logit threshold locations, differential item response (DIF) (i.e., response bias) using likelihood ratio tests, and unidimensionality using cluster analysis., Results: A statistically significant chi-square test indicated poor fit of the observed to the expected responses. More than 70% of the respondents reported a complete absence of six symptoms, reflecting significant floor effects and poor item scaling. Disordered/non-ordinal or narrow response thresholds were found for 11 of the 20 items. Item responses were significantly different by gender (p < 0.0001) and chemotherapy type (p < 0.0001). Cluster analysis findings suggest that the QLQ-CIPN20 is a unidimensional scale due to the absence of item clusters., Conclusions: Rasch model testing revealed psychometric weaknesses that could be addressed by revising the QLQ-CIPN20's problematic items and response options. Alternatively, perhaps the new gold standard CIPN measurement approach in future intervention trials should involve use of only the best items, which would also allow comparisons across previous trials that utilized the QLQ-CIPN20.
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- 2019
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29. Impact of using a broad-based multi-institutional approach to build capacity for non-communicable disease research in Thailand.
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Potempa K, Rajataramya B, Barton DL, Singha-Dong N, Stephenson R, Smith EML, Davis M, Dinov I, Hampstead BM, Aikens JE, Saslow L, Furspan P, Sarakshetrin A, and Pupjain S
- Subjects
- Cultural Competency, Data Mining, Leadership, Medical Informatics, Mentors, Michigan, Public Health, Thailand, Universities, Biomedical Research, Capacity Building, Developing Countries, Health Workforce, International Cooperation, Noncommunicable Diseases, Research Personnel
- Abstract
Thailand's transition to high middle-income country status has been accompanied by demographic changes and associated shifts in the nation's public health challenges. These changes have necessitated a significant shift in public health focus from the treatment of infectious diseases to the more expensive and protracted management of non-communicable diseases (NCDs) in older adults.In 2010, in response to this shift in focus, the University of Michigan and colleagues at the Praboromarajchanok Institute for Health Workforce Development in Thailand began work on a broad-based multi-institutional programme for NCD research capacity-building in Thailand.To begin to build a base of intervention research we paired our programme's funded Thai postdoctoral fellows with United States mentors who have strong programmes of intervention research. One direct impact of the programme was the development of research 'hubs' focused upon similar areas of investigative focus such as self-management of cancer symptoms, self-management of HIV/AIDS and health technology information applications for use in community settings. Within these hubs, interventions with proven efficacy in the United States were used as a foundation for culturally relevant interventions in Thailand. The programme also aimed to develop the research support structures necessary within departments and colleges for grant writing and management, dissemination of new knowledge, and ethical conduct of human subject research.In an effort to capitalise on large national health datasets and big data now available in Thailand, several of the programme's postdoctoral fellows began projects that use data science methods to mine this asset. The investigators involved in these ground-breaking projects form the core of a network of research hubs that will be able to capitalise on the availability of lifespan health data from across Thailand and provide a robust working foundation for expansion of research using data science approaches.Going forward, it is vitally important to leverage this groundwork in order to continue fostering rapid growth in NCD research and training as well as to capitalise upon these early gains to create a sustaining influence for Thailand to lead in NCD research, improve the health of its citizens, and provide ongoing leadership in Southeast Asia.
- Published
- 2019
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30. Genetic Variants Associated With Vincristine-Induced Peripheral Neuropathy in Two Populations of Children With Acute Lymphoblastic Leukemia.
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Li L, Sajdyk T, Smith EML, Chang CW, Li C, Ho RH, Hutchinson R, Wells E, Skiles JL, Winick N, Martin PL, and Renbarger JL
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- Adolescent, Child, Child, Preschool, Cohort Studies, Female, Genetic Variation drug effects, Humans, Infant, Male, Peripheral Nervous System Diseases chemically induced, Polymorphism, Single Nucleotide genetics, Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy, Young Adult, Antineoplastic Agents, Phytogenic adverse effects, Genetic Variation genetics, Genome-Wide Association Study methods, Peripheral Nervous System Diseases genetics, Precursor Cell Lymphoblastic Leukemia-Lymphoma genetics, Vincristine adverse effects
- Abstract
Vincristine is one of the core chemotherapy agents used in the treatment of pediatric acute lymphoblastic leukemia (ALL). However, one of the major toxicities resulting from vincristine exposure is vincristine-induced peripheral neuropathy (VIPN). When VIPN results in significant morbidity, the vincristine dose may need to be reduced, thus potentially decreasing the effectiveness of treatment. To date, there are no robust biomarkers used clinically to determine which patients will be at risk for worse neuropathy. The current study included genomewide association study (GWAS) in two independent cohorts: Pediatric Oncology Group (POG) ALL trials and a multicenter study based at Indiana University in children with ALL. A meta-analysis of the cohorts identified two single-nucleotide polymorphisms (SNPs), rs1045644 and rs7963521, as being significantly (P value threshold 0.05/4749 = 1.05E-05) associated with neuropathy. Subsequently these SNPs may be effective biomarkers of VIPN in children with ALL., (© 2018 The Authors Clinical Pharmacology & Therapeutics © 2018 American Society for Clinical Pharmacology and Therapeutics.)
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- 2019
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31. Mechanisms, Predictors, and Challenges in Assessing and Managing Painful Chemotherapy-Induced Peripheral Neuropathy.
- Author
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Kanzawa-Lee GA, Knoerl R, Donohoe C, Bridges CM, and Smith EML
- Subjects
- Antineoplastic Agents therapeutic use, Humans, Quality of Life, Antineoplastic Agents adverse effects, Pain chemically induced, Pain Management methods, Peripheral Nervous System Diseases chemically induced
- Abstract
Objective: To describe the known predictors and pathophysiological mechanisms of chronic painful chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors and the challenges in assessing and managing it., Data Sources: PubMed/Medline, CINAHL, Scopus, and PsycINFO., Conclusion: The research on chronic painful CIPN is limited. Additional research is needed to identify the predictors and pathophysiological mechanisms of chronic painful CIPN to inform the development of assessment tools and management options for this painful and possibly debilitating condition., Implications for Nursing Practice: Recognition of the predictors of chronic painful CIPN and proactive CIPN assessment and palliative management are important steps in reducing its impact on physical function and quality of life., (Copyright © 2019 Elsevier Inc. All rights reserved.)
- Published
- 2019
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32. Psychometric Testing of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale Using Pooled Chemotherapy-Induced Peripheral Neuropathy Outcome Measures Standardization and Alliance for Clinical Trials in Oncology A151408 Study Data.
- Author
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Smith EML, Banerjee T, Yang JJ, Bridges CM, Alberti P, Sloan JA, and Loprinzi C
- Subjects
- Adult, Aged, Aged, 80 and over, Cross-Sectional Studies, Europe, Female, Humans, Male, Middle Aged, Patient Reported Outcome Measures, Psychometrics, Randomized Controlled Trials as Topic, Reproducibility of Results, Antineoplastic Agents adverse effects, Neoplasms drug therapy, Peripheral Nervous System Diseases chemically induced, Quality of Life psychology, Surveys and Questionnaires
- Abstract
Background: No criterion-standard patient-reported outcome measure of chemotherapy-induced peripheral neuropathy (CIPN) exists., Objectives: The aims of this study were to reevaluate the sensitivity, reliability, and validity of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN (QLQ-CIPN20) measure and suggest possible revisions that could strengthen it., Methods: Cross-sectional QLQ-CIPN20 data from 8 European countries (n = 271) were pooled with data from 4 North American multisite CIPN intervention trials (n = 884). The combined sample (N = 1155) included patients with varied cancer diagnoses who had received neurotoxic chemotherapy. Item score ranges, Cronbach's α, and exploratory factor analysis were used to evaluate sensitivity, internal consistency, and structural validity., Results: Individual item mean scores ranged from 1.21 to 2.34 (SD range, 0.55-1.17). All item scores encompassed the entire 1 to 4 range. We recommend that 4 items be removed because of low item-item score correlations (r < 0.30). On the basis of the remaining 16 items, 88% of the variance was explained by 2 factors whose Cronbach's α coefficients were .90 and .85. However, items lacked conceptual alignment with previously published factor structures., Conclusion: Using a large, diverse sample of European and North American participants, the reduced 16-item QLQ-CIPN20 is sensitive and internally consistent. However, factor analysis results revealed an unstable factor structure., Implications for Practice: The use of a reliable, valid, and sensitive criterion-standard QLQ-CIPN20 variant in clinical practice settings could improve function, quality of life, and CIPN symptom control by facilitating patient reporting and thereby clinician awareness of this underrecognized consequence of cancer therapy.
- Published
- 2019
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33. Corrigendum to 'Estimating the Frequency, Severity, and Clustering of SPADE Symptoms in Chronic Painful Chemotherapy-Induced Peripheral Neuropathy' Pain Management Nursing 2018;19(4):354-365.
- Author
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Knoerl R, Chornoby Z, and Smith EML
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- 2019
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34. Pilot Study of an Internet-Based Self-Management Program for Symptom Control in Patients With Early-Stage Breast Cancer.
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Henry NL, Kidwell KM, Alsamarraie C, Bridges CM, Kwiatkowski C, Clauw DJ, Smith EML, and Williams DA
- Subjects
- Antineoplastic Combined Chemotherapy Protocols therapeutic use, Female, Follow-Up Studies, Humans, Middle Aged, Neoplasm Staging, Pilot Projects, Prospective Studies, Survival Rate, Treatment Outcome, Breast Neoplasms therapy, Cancer Survivors statistics & numerical data, Internet statistics & numerical data, Self-Management
- Abstract
Purpose: Many survivors of breast cancer experience an array of chronic symptoms, including pain, insomnia, and fatigue. Few effective therapies have been identified. Behavioral management programs to address similar symptom clusters in other chronic conditions have been effective. The objective of this study was to determine the effect of an Internet-based lifestyle and behavioral self-management program on cancer-related symptoms., Patients and Methods: Women with stage 0 to 3 breast cancer who reported insomnia, pain, or fatigue as their primary symptom of concern during the 7 days before enrollment were enrolled. Local therapies and/or chemotherapy were completed at least 3 months before enrollment. Patients were assessed at baseline and after 8 weeks, and they completed the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile and Patient Global Impression of Change (PGIC) questionnaire electronically. Change in each of the eight symptom domains was assessed., Results: Fifty patients enrolled. In the 45 patients with both baseline and 8-week PROMIS data, statistically significant improvements in anxiety, sleep, fatigue, activity level, and pain severity were reported. Of the 35 patients who responded to the PGIC, 62.9% reported improvement in their primary symptom. Those who reported fatigue as their primary symptom reported greatest overall benefit in multiple symptom improvement, including improvements in fatigue, anxiety, pain severity, pain interference, and participation in social activities., Conclusions: These findings suggest that this lifestyle and behavioral management program may improve multiple symptoms in breast cancer survivors when delivered via the Internet. Randomized studies are warranted to evaluate the efficacy of the online intervention compared with standard symptom management approaches and to identify patients most likely to benefit.
- Published
- 2018
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35. Pharmacometabolomics reveals a role for histidine, phenylalanine, and threonine in the development of paclitaxel-induced peripheral neuropathy.
- Author
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Sun Y, Kim JH, Vangipuram K, Hayes DF, Smith EML, Yeomans L, Henry NL, Stringer KA, and Hertz DL
- Subjects
- Adult, Aged, Biomarkers blood, Breast Neoplasms blood, Breast Neoplasms complications, Breast Neoplasms pathology, Female, Histidine blood, Humans, Magnetic Resonance Spectroscopy, Middle Aged, Paclitaxel adverse effects, Peripheral Nervous System Diseases chemically induced, Peripheral Nervous System Diseases pathology, Phenylalanine blood, Threonine blood, Breast Neoplasms drug therapy, Metabolomics, Paclitaxel administration & dosage, Peripheral Nervous System Diseases blood
- Abstract
Purpose: Approximately 25% of breast cancer patients experience treatment delays or discontinuation due to paclitaxel-induced peripheral neuropathy (PN). Currently, there are no predictive biomarkers of PN. Pharmacometabolomics is an informative tool for biomarker discovery of drug toxicity. We conducted a secondary whole blood pharmacometabolomics analysis to assess the association between pretreatment metabolome, early treatment-induced metabolic changes, and the development of PN., Methods: Whole blood samples were collected pre-treatment (BL), just before the end of the first paclitaxel infusion (EOI), and 24 h after the first infusion (24H) from sixty patients with breast cancer receiving (80 mg/m
2 ) weekly treatment. Neuropathy was assessed at BL and prior to each infusion using the sensory subscale (CIPN8) of the EORTC CIPN20 questionnaire. Blood metabolites were quantified from 1-D-1 H-nuclear magnetic resonance spectra using Chenomx® software. Metabolite concentrations were normalized in preparation for Pearson correlation and one-way repeated measures ANOVA with multiple comparisons corrected by false discovery rate (FDR)., Results: Pretreatment histidine, phenylalanine, and threonine concentrations were inversely associated with maximum change in CIPN8 (ΔCIPN8) (p < 0.02; FDR ≤ 25%). Paclitaxel caused a significant change in concentrations of 2-hydroxybutyrate, 3-hydroxybutyrate, pyruvate, o-acetylcarnitine, and several amino acids from BL to EOI and/or 24H (p < 0.05; FDR ≤ 25%), although these changes were not associated with ΔCIPN8., Conclusions: Whole blood metabolomics is a feasible approach to identify potential biomarker candidates of paclitaxel-induced PN. The findings suggest that pretreatment concentrations of histidine, phenylalanine, and threonine may be predictive of the severity of future PN and paclitaxel-induced metabolic changes may be related to disruption of energy homeostasis.- Published
- 2018
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36. Chemotherapy-Induced Peripheral Neuropathy: Use of an Electronic Care Planning System to Improve Adherence to Recommended Assessment and Management Practices.
- Author
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Knoerl R, Bridges C, Smith GL, Yang JJ, Kanzawa-Lee G, and Smith EML
- Subjects
- Adult, Aged, Aged, 80 and over, Disease Management, Female, Humans, Michigan, Middle Aged, Prospective Studies, Retrospective Studies, Surveys and Questionnaires, Antineoplastic Agents adverse effects, Breast Neoplasms drug therapy, Internet, Medication Adherence, Patient Care Planning, Peripheral Nervous System Diseases chemically induced, Peripheral Nervous System Diseases drug therapy, Telemedicine methods
- Abstract
Background: Chemotherapy-induced peripheral neuropathy (CIPN) is often inadequately assessed and managed by advanced practice providers., Objectives: The aim is to explore the impact of CIPN assessment training and electronic care planning system (CPS) use on CIPN assessment documentation and guidelines adherence., Methods: The authors used a pre-/post-test, prospective design with two retrospective chart reviews. Six providers received CIPN assessment training and used the CPS to manage CIPN for 75 women receiving neurotoxic chemotherapy., Findings: CPS use significantly improved documentation of numbness and nonpainful CIPN management strategies but had no effect on documentation of additional assessment variables or painful CIPN management.
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- 2018
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37. Psychometric properties of the Menopause Specific Quality of Life questionnaire among Thai women with a history of breast cancer.
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Phligbua W, Smith EML, and Barton DL
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- Adult, Aged, Breast Neoplasms complications, Cross-Sectional Studies, Factor Analysis, Statistical, Female, Hair, Humans, Middle Aged, Psychometrics, Reproducibility of Results, Self Report, Sexual Behavior, Surveys and Questionnaires, Thailand, Asian People psychology, Breast Neoplasms ethnology, Breast Neoplasms psychology, Menopause ethnology, Menopause psychology, Quality of Life
- Abstract
Purpose: This study evaluated the psychometric properties of the Thai Menopause Specific Quality of Life Questionnaire (MENQOL) instrument in menopausal Thai women with a history of breast cancer., Methods: Two hundred and ninety women with a history of breast cancer who reported hot flashes completed the Thai MENQOL. Internal consistency reliability and item analysis were used to evaluate the reliability of the Thai MENQOL. Construct validity was evaluated by examining the correlations between the self-reported hot flash frequency and severity with the vasomotor MENQOL subscale (convergent validity); and assessed using exploratory factor analysis (structural validity)., Results: The Cronbach's alpha coefficient for the MENQOL total scale was 0.86 and for the vasomotor, psychosocial, physical, sexual domains were 0.73, 0.78, 0.81, and 0.83, respectively. Self-reported frequency and severity of hot flashes were correlated significantly with the vasomotor subscale (r's ≥ 0.50, p's < 0.001). The single item "increased facial hair" was poorly correlated with most items (r = 0.13). Confirmatory factor analysis supported four factors explaining 42.35% of the total variance. Item-domain correlation analysis showed that all items correlated more strongly with their own domains than with other domains., Conclusions: The Thai version of the MENQOL demonstrates good psychometric properties (internal consistency reliability, convergent validity, and structural validity). We recommend removal of the single item, "increased facial hair" from the Thai version due to low correlations with most items. The Thai MENQOL can be used to measure menopause-related quality of life in Thai women with a history of breast cancer experiencing menopausal symptoms., (Copyright © 2018 Elsevier Ltd. All rights reserved.)
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- 2018
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38. Estimating the Frequency, Severity, and Clustering of SPADE Symptoms in Chronic Painful Chemotherapy-Induced Peripheral Neuropathy.
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Knoerl R, Chornoby Z, and Smith EML
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- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols standards, Anxiety etiology, Cross-Sectional Studies, Depression etiology, Fatigue etiology, Female, Humans, Male, Middle Aged, Pain Measurement methods, Pilot Projects, Sleep Disorders, Circadian Rhythm etiology, Surveys and Questionnaires, Syndrome, Antineoplastic Combined Chemotherapy Protocols adverse effects, Neoplasms complications, Peripheral Nervous System Diseases complications
- Abstract
Background: Patients undergoing treatment for cancer commonly experience symptoms such as sleep disturbance, pain, anxiety, depression, and low energy/fatigue (SPADE), subsequently altering physical function and complicating effective symptom management. However, little is known about the frequency, severity, and clustering of SPADE symptoms in individuals with chronic painful chemotherapy-induced peripheral neuropathy (CIPN). Aims/Design: The purpose of this cross-sectional, secondary analysis was to describe the frequency, severity, and clustering of SPADE symptoms and their association with physical function in individuals with chronic painful CIPN. Participants/Subjects: Sixty individuals with chronic painful CIPN were recruited from five academic and community oncology outpatient center to participate in a randomized controlled pilot trial designed to test the efficacy of a cognitive behavioral therapy-based pain management program., Methods: Participants completed the 0-10 Average CIPN Pain Numerical Rating Scale and Patient-Reported Outcome Measurement Information System measures for sleep-related impairment, anxiety, depression, fatigue, and pain interference via tablet before being randomly assigned to a study arm. The frequency, severity, and clustering of SPADE symptoms were calculated via descriptive statistics and Partitioning Around Medoids cluster analysis. Spearman rank correlation was performed to determine the association between number of SPADE symptoms and pain interference severity., Results and Conclusions: Participants (n = 59) experienced numerous SPADE symptoms. 66.1% of participants experienced at least two SPADE symptoms concurrently. The cluster analysis revealed high (n = 36) and low (n = 23) severity subgroups. There was a moderate correlation (r = 0.48) between the number of SPADE symptoms and pain interference severity. Determining the clustering of SPADE symptoms in individuals with chronic painful CIPN may lead to targeted multifaceted interventions to improve physical function., (Copyright © 2018 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.)
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- 2018
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39. Médiateurs potentiels d’amélioration de la neuropathie périphérique chimio-induite douloureuse par une intervention cognitivocomportementale en ligne.
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Knoerl R, Barton DL, Holden JE, Krauss JC, LaVasseur B, and Smith EML
- Abstract
Competing Interests: DIVULGATION Les auteurs déclarent n’avoir aucun conflit d’intérêts. La préparation de ces travaux a été rendue possible grâce à la bourse de nouveau chercheur de la University of Michigan School of Nursing et à la subvention de recherche Rackham pour étudiant à la maîtrise. La source de financement n’a joué aucun rôle dans la structure de l’étude, la collecte et l’analyse de données ou la rédaction de cet article. La création du site Web PROSPECT (PROactive Self-management Program for Effects of Cancer Treatment [programme d’autogestion proactive des effets du traitement contre le cancer]) était soutenue par la Damon Runyon Cancer Research Foundation (CI-53-10) accordé à Norah Lynn Henry. PROSPECT s’est inspiré du site Web Fibroguide.com qui a été conçu grâce aux subventions portant les numéros R01-AR050044 (NIAMS/NIH) et DAMD 17-00-2-0018 (Département de la Défense).
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- 2018
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40. Potential mediators of improvement in painful chemotherapy-induced peripheral neuropathy via a web-based cognitive behavioural intervention.
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Knoerl R, Barton DL, Holden JE, Krauss JC, LaVasseur B, and Smith EML
- Abstract
Purpose: Preliminary evidence suggests that a self-guided cognitive and behaviourally-based pain management intervention (PROSPECT) is effective for chronic painful chemotherapy-induced peripheral neuropathy (CIPN), but its mechanism of action is unknown. The purpose of this secondary analysis was to explore if changes in anxiety, depression, sleep-related impairment, or fatigue mediated improvements in worst pain following PROSPECT in individuals with chronic painful CIPN., Methods: Sixty participants were randomized to receive self-guided cognitive behavioural pain management (access for eight weeks) or treatment as usual. A seven-day worst CIPN pain diary and the PROMIS measures of anxiety, depression, fatigue, and sleep-related impairment were administered pre/posttest (eight-weeks). Causal mediation analysis was used to quantify mediators of worst pain improvement., Results: None of the hypothesized mediators had a statistically significant effect on worst pain (n=38)., Implications: Further research is needed to identify potential mediators of pain intensity that can be targeted by specific cognitive behavioural strategies to improve painful CIPN severity., Competing Interests: DISCLOSURES The authors declare no conflicts of interest. This work was supported by the University of Michigan School of Nursing New Investigator Award and Rackham Graduate Student Research Grant. The funding source had no role in study design, data collection/analysis, or manuscript preparation. Creation of the PROSPECT website was supported by the Damon Runyon Cancer Research Foundation (#CI-53-10) awarded to Norah Lynn Henry. PROSPECT was adapted from the website, Fibroguide.com, which was developed with support from Grant numbers R01-AR050044 (NIAMS/NIH), and DAMD 17-00-2-0018 (Department of Defense).
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- 2018
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41. Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy: A Multicenter, Pilot, Randomized, Wait-List Controlled Trial.
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Knoerl R, Smith EML, Barton DL, Williams DA, Holden JE, Krauss JC, and LaVasseur B
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- Adult, Aged, Antineoplastic Agents adverse effects, Female, Follow-Up Studies, Humans, Male, Middle Aged, Peripheral Nervous System Diseases chemically induced, Prospective Studies, Self Report, Time Factors, Treatment Outcome, Waiting Lists, Cognitive Behavioral Therapy methods, Online Systems, Pain etiology, Pain rehabilitation, Pain Measurement, Peripheral Nervous System Diseases complications
- Abstract
The purpose of this pilot, parallel, randomized controlled trial was to examine the efficacy of a self-guided online cognitive and behaviorally-based pain management intervention (Proactive Self-Management Program for Effects of Cancer Treatment [PROSPECT]) to reduce "worst" pain for individuals with chronic painful chemotherapy-induced peripheral neuropathy (CIPN). Secondary outcomes included "average" pain, nonpainful CIPN symptom severity, impression of change, and pain interference. Sixty patients with chronic painful CIPN were recruited from 5 outpatient academic and community cancer centers. Patients were randomized in a 1:1 ratio to receive either 8 weeks of PROSPECT or usual care. A 7-day electronic "worst" pain intensity diary and standardized measures of pain interference, nonpainful CIPN symptom severity, impression of change, and "average" pain were administered pre/post intervention. Postintervention mean scores were evaluated between groups using analysis of covariance adjusting for baseline. Individuals who received the PROSPECT intervention (n = 19) had significantly greater improvements in "worst pain" compared with individuals receiving usual care (n = 19; P = .046, d = .58). There were no significant differences in mean scores between groups for the secondary outcomes (n = 42). A larger, adequately powered study testing the PROSPECT intervention is needed to determine if improvements in pain may be sustained, evaluate the effect of the intervention on the secondary outcomes, and identify mediators of pain intensity-related improvement., Perspective: This study explores the efficacy of an 8-week online cognitive behavioral pain management intervention for chronic painful CIPN. Intervention use resulted in greater improvements in "worst" pain than usual care alone. The findings provide preliminary support for the efficacy of a nonpharmacological intervention for chronic painful CIPN., (Copyright © 2017 The American Pain Society. Published by Elsevier Inc. All rights reserved.)
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- 2018
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42. In Search of a Gold Standard Patient-Reported Outcome Measure for Use in Chemotherapy- Induced Peripheral Neuropathy Clinical Trials.
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Smith EML, Knoerl R, Yang JJ, Kanzawa-Lee G, Lee D, and Bridges CM
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- Adult, Aged, Aged, 80 and over, Case-Control Studies, Clinical Trials as Topic, Female, Humans, Longitudinal Studies, Male, Middle Aged, Prospective Studies, Reproducibility of Results, Patient Reported Outcome Measures, Peripheral Nervous System Diseases drug therapy
- Abstract
Purpose: To test a reduced version-CIPN15-of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy scale (QLQ-CIPN20) to establish a possible gold-standard patient-reported outcome measure for chemotherapy-induced peripheral neuropathy (CIPN)., Methods: Using a prospective, longitudinal, case-control design, patients (n = 121) receiving neurotoxic chemotherapy completed the CIPN15 at baseline and 12 weeks and underwent objective neurological assessment using the 5-item Total Neuropathy Score-Clinical (TNSc). Healthy controls (n = 30) completed the CIPN15 once. Structural validity was evaluated using factor analysis. Because a stable factor structure was not found, a sum score was used to evaluate measures of the CIPN15's psychometric properties-reliability, validity, sensitivity, and responsiveness-as follows: internal consistency via Cronbach's α and item-item correlations; test-retest reliability via correlation between 2 CIPN15 scores from each patient; concurrent validity via correlation between CIPN15 and 5-item TNSc scores; contrasting group validity via comparison of CIPN15 scores from patients and healthy controls; sensitivity via descriptive statistics (means, standard deviation, ranges); and responsiveness via Cohen's d effect size., Results: Most patients received single agent oxaliplatin (33.7%), paclitaxel (21.2%), or more than 1 neurotoxic drug concurrently (29.8%). Factor analysis revealed no stable factor structure. Cronbach's α for the CIPN15 sum score was 0.91 (confidence interval [CI] = 0.89-0.93). Test-retest reliability was demonstrated based on strong correlations between the 2 scores obtained at the 12-week time point ( r = 0.86; CI = 0.80-0.90). The CIPN15 and 5-item TNSc items reflecting symptoms (not signs) were moderately correlated ( r range 0.57-0.72): concurrent validity. Statistically significant differences were found between patient and healthy control CIPN15 mean scores ( P < .0001): contrasting group validity. All items encompassed the full score range but the CIPN15 linearly converted sum score did not: sensitivity. The CIPN15 was responsive based on a Cohen's d of 0.52 (CI = 0.25-0.79)., Conclusion: The sum-scored CIPN15 is reliable, valid, sensitive, and responsive when used to assess taxane- and platinum-induced CIPN.
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- 2018
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