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Yun Jiang,1 Karen E Wickersham,2 Xingyu Zhang,1 Debra L Barton,1 Karen B Farris,3 John C Krauss,4 Marcelline R Harris1 1University of Michigan School of Nursing, Ann Arbor, MI, USA; 2University of South Carolina College of Nursing, Columbia, SC, USA; 3University of Michigan College of Pharmacy, Ann Arbor, MI, USA; 4University of Michigan Medical School, Michigan Medicine, Ann Arbor, MI, USACorrespondence: Yun JiangUniversity of Michigan School of Nursing, 400 North Ingalls Street, Ann Arbor, MI 48109, USAEmail jiangyu@umich.eduPurpose: There are growing concerns about patients’ adherence to oral anticancer agents (OAAs), and the need for patients to engage in self-management of OAA-related side effects. We assessed associations among adherence, severity of side effects, and effectiveness of self-management of side effects in patients taking capecitabine.Methods: Adherence to capecitabine at 6 weeks was measured by the Medication Event Monitoring System among 50 patients with gastrointestinal cancers. Severity of side effects related to capecitabine and effectiveness of self-management of side effects were captured using the Modified Self-Care Diary at the time of enrollment and weekly for 6 weeks. Spearman’s correlation, Mann–Whitney U-tests, and multiple linear regression were conducted, p

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a troublesome chronic symptom that has no proven pharmacologic treatment. The purpose of this double-blind randomized placebo-controlled trial was to evaluate a novel compounded topical gel for this problem.Methods: Patients with CIPN were randomized to baclofen 10 mg, amitriptyline HCL 40 mg, and ketamine 20 mg in a pluronic lecithin organogel (BAK-PLO) versus placebo (PLO) to determine its effect on numbness, tingling, pain, and function. The primary endpoint was the baseline-adjusted sensory subscale of the EORTC QLQ-CIPN20, at 4 weeks.Results: Data in 208 patients reveal a trend for improvement that is greater in the BAK-PLO arm over placebo in both the sensory (p = 0.053) and motor subscales (p = 0.021). The greatest improvements were related to the symptoms of tingling, cramping, and shooting/burning pain in the hands as well as difficulty in holding a pen. There were no undesirable toxicities associated with the BAK-PLO and no evidence of systemic toxicity.Conclusion: Topical treatment with BAK-PLO appears to somewhat improve symptoms of CIPN. This topical gel was well tolerated, without evident systemic toxicity. Further research is needed with increased doses to better clarify the clinical role of this treatment in CIPN. [ABSTRACT FROM AUTHOR]

Purpose: This pilot trial sought to investigate whether any of three doses of American ginseng (Panax quinquefolius) might help cancer-related fatigue. A secondary aim was to evaluate toxicity.Methods: Eligible adults with cancer were randomized in a double-blind manner, to receive American ginseng in doses of 750, 1,000, or 2,000 mg/day or placebo given in twice daily dosing over 8 weeks. Outcome measures included the Brief Fatigue Inventory, vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36), and the Global Impression of Benefit Scale at 4 and 8 weeks.Results: Two hundred ninety patients were accrued to this trial. Nonsignificant trends for all outcomes were seen in favor of the 1,000- and 2,000-mg/day doses of American ginseng. Area under the curve analysis of activity interference from the Brief Fatigue Inventory was 460-467 in the placebo group and 750 mg/day group versus 480-551 in the 1,000- and 2,000-mg/day arms, respectively. Change from baseline in the vitality subscale of the SF-36 was 7.3-7.8 in the placebo and the 750-mg/day arm, versus 10.5-14.6 in the 1,000- and 2,000-mg/day arms. Over twice as many patients on ginseng perceived a benefit and were satisfied with treatment over those on placebo. There were no significant differences in any measured toxicities between any of the arms.Conclusion: There appears to be some activity and tolerable toxicity at 1,000-2,000 mg/day doses of American ginseng with regard to cancer-related fatigue. Thus, further study of American ginseng is warranted. [ABSTRACT FROM AUTHOR]

Goals Of Work: The objectives of this pilot trial were to assess the potential efficacy and safety of levetiracetam for the treatment of hot flashes, a major cause of morbidity among breast cancer survivors.Patients and Methods: Women, aged 18 years or more, with a history of breast cancer or those who wished to avoid estrogen because of a perceived increased risk of breast cancer, who were experiencing bothersome hot flashes (more than or equal to 14 times per week, for more than or equal to 1 month before study entry), were included. During the baseline week, general demographic characteristics, hot flash information, and quality of life data were obtained. At the beginning of week 2, patients were started on levetiracetam for a total of 4 weeks. Information about hot flashes, quality of life, and toxicity were collected during these 4 weeks and compared with the baseline week.Main Results: After treatment with levetiracetam for 4 weeks (N = 19), mean hot flash scores (frequency times mean severity) were reduced by 57%, and mean hot flash frequencies were reduced by 53%, compared to the baseline week; both these reductions were greater than what would be expected with a placebo (20-25% reduction). There were significant improvements in abnormal sweating (p = 0.004), hot flash distress (p = 0.0002), and satisfaction of hot flash control (p = 0.0001), when comparing data from the fourth week of treatment to the baseline week. Twenty-nine percent of the subjects did not complete the study because of treatment-related adverse events, with the most frequently reported side effects being somnolence, fatigue, and dizziness, usually with mild to moderate intensity.Conclusion: The results of this pilot trial suggest that levetiracetam might be an effective therapy for the treatment of hot flashes. Further data are needed to test this hypothesis, evaluating the efficacy and toxicity of this agent. [ABSTRACT FROM AUTHOR]

Cancer and its treatment are often associated with symptoms such as depression, somnolence, cognitive abnormalities, and fatigue. Methylphenidate, a stimulant medication, is commonly used to treat these symptoms. Several small pilot and a few adequately powered studies have assessed the safety and efficacy of methylphenidate in patients with cancer Overall, the studies so far suggest that methylphenidate is well-tolerated in patients with cancer Further, the studies have provided initial evidence of efficacy of this agent in patients with cancer The present article reviews the evidence base behind the use of methylphenidate in these patients. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To provide prospective information on the potential utility of paroxetine for treating hot flashes In men receiving androgen ablation therapy for prostate cancer. PATIENTS AND METHODS: Men with symptomatic androgen ablation therapy-related hot flashes were entered into this clinical trial between August 2001 and October 2003. After a baseline week of documentation of the frequency of hot flashes, patients were assigned to receive paroxetine; the initial dosage was 12.5 mg/d, and it was increased to 37.5 mg/d over the ensuing 4 weeks. RESULTS: Of the 24 patients in whom medication was initiated, 18 completed the 5-week study. In these patients, the median frequency of hot flashes decreased from 6.2 per day during the baseline week to 2.5 per day during the last study week. Hot flash scores (frequency x mean severity) during the same period decreased from 10.6 per day to 3.0 per day. Overall, paroxetine was well tolerated by most patients. CONCLUSION: The results from this trial suggest that paroxetine Is an effective agent for diminishing hot flashes in men receiving androgen ablation therapy. [ABSTRACT FROM AUTHOR]

Venlafaxine is the most studied and most effective nonhormonal therapy for hot flashes in this country. Experience with this drug and anecdotal and pilot data have prompted investigation of similar agents. [ABSTRACT FROM AUTHOR]

Women with breast cancer have many adverse symptoms, of which some are specific to premenopausal patients. Management of these common symptoms include non-hormonal drugs, such as antidepressants and antiseizure compounds to alleviate hot flushes. Non-oestrogenic vaginal lubricants seem to moderately decrease occurrence of vaginal dryness and dyspareunia. Transdermal testosterone alone has not been shown to improve libido in these women. Options for fertility preservation include cryopreservation of embryos or oocytes before chemotherapy. Exercise is the one evidenced-based intervention shown to positively affect cancer-related fatigue. However, effective prevention and treatments for peripheral neuropathy and paclitaxel acute pain syndrome remain elusive. Weight-bearing exercise helps to maintain bone strength with adequate intake of calcium and vitamin D. Use of bisphosphonates in women taking aromatase inhibitors (combined with ovarian suppression in premenopausal women) to prevent bone fractures has not been substantiated, although it should be considered in women with osteoporosis. No specific drug has been shown to prevent radiation-induced dermatitis alone. Although some effective treatments can counteract symptoms related to cancer or treatments, research is needed to expand evidence-based care in premenopausal survivors of breast cancer. [ABSTRACT FROM AUTHOR]

Cancer-related cognitive impairment (CRCI) is a broad term encompassing subtle cognitive problems to more severe impairment. CRCI severity is influenced by host, disease, and treatment factors and affects patients prior to, during, and following cancer treatment. The National Cancer Institute (NCI) Symptom Management and Health-Related Quality of Life Steering Committee (SxQoL SC) convened a Clinical Trial Planning Meeting (CTPM) to review the state of the science on CRCI and to develop both Phase II/III intervention trials aimed at improving cognitive function in cancer survivors with non-central nervous system (CNS) disease and longitudinal studies to understand the trajectory of cognitive impairment and contributing factors. Participants included experts in the field of CRCI, members of the SxQOL SC, patient advocates, representatives from all seven NCI Community Oncology Research Program (NCORP) Research Bases, and the NCI. Presentations focused on the following topics: measurement, lessons learned from pediatric and geriatric oncology, biomarker and mechanism endpoints, longitudinal study designs, and pharmacologic and behavioral intervention trials. Panel discussions provided guidance on priority cognitive assessments, considerations for remote assessments, inclusion of relevant biomarkers, and strategies for ensuring broad inclusion criteria. Three CTPM working groups (longitudinal studies and pharmacologic and behavioral intervention trials) convened for one year to discuss and report on top priorities and to design studies. The CTPM experts concluded sufficient data exist to advance Phase II/Phase III trials utilizing selected pharmacologic and behavioral interventions for the treatment of CRCI in the non-CNS setting with recommendations included herein., (© The Author(s) 2024. Published by Oxford University Press.)

Purpose: To describe policy and system-level interventions with potential to improve cancer care at six sites., Methods: In 2016, six institutions received foundation support to develop unique multi-component interventions aimed at improving cancer care for underserved populations. These organizations, located across the United States, participated in a cross-site evaluation to assess the overall initiative impact and to identify potentially promising policy and system-level solutions for dissemination and broader implementation. A health system and policy tracking tool was developed to collect data from each site and included a description of their efforts, strategies employed, and changes achieved (e.g., new policies, clinical protocols). Tracking tool data were analyzed using rapid qualitative analyses and a matrix approach. Semi-structured interviews were conducted with site leaders (N = 65) and were analyzed by thematic analysis., Results: Sites reported 20 system and policy efforts, which resulted in improvements to electronic health records and telehealth strategies, changes to hospital/health system policies, and standardized clinical protocols/guidelines, among others. Efforts were aimed at: (1) coordinating care across multiple providers, supported by patient navigators; (2) expanding psychosocial and supportive care; (3) improving patient-provider communication; and (4) addressing barriers to accessing care. Interview analyses provided insights into successful strategies, challenges, and implications of the COVID-19 pandemic on cancer care., Conclusions and Implications for Cancer Survivors: Despite advances in diagnosis and treatment, cancer care remains inequitable. System-level improvements aimed at eliminating common barriers faced by underserved populations offer opportunities to improve the delivery of equitable, effective, and efficient care., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Female cancer survivors often experience estrogen-deprivation symptoms, which may lead to decreases in sexual desire, vulvovaginal health (lubrication, dryness, discomfort), and sexual satisfaction. Interventions are needed to address these concerns., Aim: The objective of this secondary analysis was to determine if women with higher (better) scores on the Female Sexual Function Index (FSFI) lubrication and pain subscales reported higher desire scores based on treatment with bupropion vs placebo., Methods: Participants were part of NRG Oncology's NRG-CC004 (NCT03180294), a randomized placebo-controlled clinical trial evaluating bupropion (150 vs 300 mg) to improve sexual desire in survivors of breast or gynecologic cancer. All participants with baseline data from the FSFI lubrication, pain, and desire subscales with 5- and/or 9-week data were analyzed. The FSFI subscale scores were correlated using Spearman correlation coefficients. Logistic regression was used to determine associations between FSFI desire and other FSFI subscales while accounting for treatment arm and other covariates., Outcomes: The primary outcome of NRG Oncology's NRG-CC004 (NCT03180294) randomized phase II dose-finding trial was change from baseline to 9 weeks on the FSFI desire subscale score. Similar to the parent study, the primary outcome for this ancillary data study was the FSFI desire subscale score at 5 and 9 weeks., Results: Overall, 230 participants completed the FSFI at baseline and 189 at 9 weeks. The strongest correlations were between lubrication and pain at baseline (all participants, rho = 0.77; bupropion arms, rho = 0.82), week 5 (all participants, rho = 0.71; bupropion arms, rho = 0.68), and week 9 (all participants, rho = 0.75; bupropion arms, rho = 0.78), and the weakest correlations were between desire and pain. In patients in the treatment arms there were no interactions between lubrication or pain.The impact of various covariates on the FSFI score for desire at 9 weeks demonstrated that participants of non-White race (odds ratio [OR], 0.42; 95% CI, 0.21-0.81; P = .010), with a high lubrication score (OR, 0.36; 95% CI, 0.21-0.61; P = .0002), with a high pain score (less pain) (OR, 0.50; 95% CI, 0.29-0.87; P = .014), or with prior pelvic surgery (OR, 0.38; 95% CI, 0.23-0.63; P = .0002) had lower odds of having low desire., Clinical Implications: Acute estrogen-deprivation symptoms should be addressed prior to sexual desire intervention., Strengths and Limitations: This secondary analysis was not powered to examine all variables., Conclusion: Lubrication and pain were predictors of low desire. Therefore, vulvovaginal atrophy and associated genitourinary symptoms of menopause such as vaginal dryness and dyspareunia should be addressed prior to or in parallel with interventions for sexual desire., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: To update the ASCO guideline on the management of cancer-related fatigue (CRF) in adult survivors of cancer., Methods: A multidisciplinary panel of medical oncology, geriatric oncology, internal medicine, psychology, psychiatry, exercise oncology, integrative medicine, behavioral oncology, nursing, and advocacy experts was convened. Guideline development involved a systematic literature review of randomized controlled trials (RCTs) published in 2013-2023., Results: The evidence base consisted of 113 RCTs. Exercise, cognitive behavioral therapy (CBT), and mindfulness-based programs led to improvements in CRF both during and after the completion of cancer treatment. Tai chi, qigong, and American ginseng showed benefits during treatment, whereas yoga, acupressure, and moxibustion helped to manage CRF after completion of treatment. Use of other dietary supplements did not improve CRF during or after cancer treatment. In patients at the end of life, CBT and corticosteroids showed benefits. Certainty and quality of evidence were low to moderate for CRF management interventions., Recommendations: Clinicians should recommend exercise, CBT, mindfulness-based programs, and tai chi or qigong to reduce the severity of fatigue during cancer treatment. Psychoeducation and American ginseng may be recommended in adults undergoing cancer treatment. For survivors after completion of treatment, clinicians should recommend exercise, CBT, and mindfulness-based programs; in particular, CBT and mindfulness-based programs have shown efficacy for managing moderate to severe fatigue after treatment. Yoga, acupressure, and moxibustion may also be recommended. Patients at the end of life may be offered CBT and corticosteroids. Clinicians should not recommend L-carnitine, antidepressants, wakefulness agents, or routinely recommend psychostimulants to manage symptoms of CRF. There is insufficient evidence to make recommendations for or against other psychosocial, integrative, or pharmacological interventions for the management of fatigue.Additional information is available at www.asco.org/survivorship-guidelines.

In this work, we quantitatively compare computer simulations and existing cell tracking data of P. aeruginosa surface motility in order to analyse the underlying motility mechanism. We present a three dimensional twitching motility model, that simulates the extension, retraction and surface association of individual Type IV Pili (TFP), and is informed by recent experimental observations of TFP. Sensitivity analysis is implemented to minimise the number of model parameters, and quantitative estimates for the remaining parameters are inferred from tracking data by approximate Bayesian computation. We argue that the motility mechanism is highly sensitive to experimental conditions. We predict a TFP retraction speed for the tracking data we study that is in a good agreement with experimental results obtained under very similar conditions. Furthermore, we examine whether estimates for biologically important parameters, whose direct experimental determination is challenging, can be inferred directly from tracking data. One example is the width of the distribution of TFP on the bacteria body. We predict that the TFP are broadly distributed over the bacteria pole in both walking and crawling motility types. Moreover, we identified specific configurations of TFP that lead to transitions between walking and crawling states., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Barton et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Rates of sleep disturbance among survivors of cancer are more than 3 times higher than the general population. Causes of sleep disturbance among survivors are many and multifaceted, including anxiety and fear related to cancer diagnosis and treatments. Cognitive behavioral therapy for insomnia (CBT-I) is considered a first-line treatment for insomnia; However, a lack of access to trained professionals and limited insurance coverage for CBT-I services has limited patient access to these effective treatments. Evidence supports digital delivery of CBT-I (dCBT-I), but there is only limited evidence to support its use among survivors of cancer. Broad adoption of smartphone technology provides a new channel to deliver dCBT-I, but no prior studies have evaluated mobile dCBT-I interventions for survivors. To address the need for accessible and efficacious CBT-I for survivors of cancer, the Mi Sleep Coach program was developed to adapt CBT-I for delivery to survivors of cancer as a self-directed mobile health app., Objective: This single-arm feasibility study assessed the adherence, attrition, usefulness, and satisfaction of the Mi Sleep Coach app for insomnia., Methods: A 7-week, single-arm study was conducted, enrolling adult survivors of breast, prostate, or colon cancer reporting sleep disturbances., Results: In total, 30 participants were enrolled, with 100% completing the study and providing data through week 7. Further, 9 out of 10 app features were found to be useful by 80% (n=24) to 93% (n=28) of the 30 participants. Furthermore, 27 (90%) participants were satisfied with the Mi Sleep Coach app and 28 (93%) would recommend the use of the Mi Sleep Coach app for those with insomnia. The Insomnia Severity Index showed a decrease from baseline (18.5, SD 4.6) to week 7 (10.4, SD 4.2) of 8.1 (P<.001; Cohen d=1.5). At baseline, 25 (83%) participants scored in the moderate (n=19; 15-21) or severe (n=6; 22-28) insomnia range. At week 7, a total of 4 (13%) patients scored in the moderate (n=4) or severe (n=0) range. The number of patients taking prescription sleep medications decreased from 7 (23%) at baseline to 1 (3%; P<.001) at week 7. The number of patients taking over-the-counter sleep medications decreased from 14 (47%) at baseline to 9 (30%; P=.03) at week 7., Conclusions: The Mi Sleep Coach app demonstrated high levels of program adherence and user satisfaction and had large effects on the severity of insomnia among survivors of cancer. The Mi Sleep Coach app is a promising intervention for cancer-related insomnia, and further clinical trials are warranted. If proven to significantly decrease insomnia in survivors of cancer in future randomized controlled clinical trials, this intervention would provide more survivors of cancer with easy access to evidence-based CBT-I treatment., Trial Registration: ClinicalTrials.gov NCT04827459; https://clinicaltrials.gov/study/NCT04827459., (©Noel Arring, Debra L Barton, Carolyn Lafferty, Bryana Cox, Deirdre A Conroy, Lawrence An. Originally published in JMIR Formative Research (https://formative.jmir.org), 26.04.2024.)

This study examines feedback from two interventions, hypnosis and progressive muscle relaxation (PMR), to improve body image in a randomized phase II trial. Eighty-seven women were randomized either to hypnosis or PMR. Sixty-three women (72%) were motivated to write comments about their study experience. These comments were explored in an unplanned qualitative analysis. Thematic analysis generated five themes, suggesting both hypnosis and PMR may improve body image through the ability to relax and manage stress, sleep better, improve mood and create a mind-body connection. Sexual health emerged as a theme for participants in only the hypnosis group which suggests hypnotic suggestions for body image may improve overall sexual health. Additional research is needed to assess this further.

Purpose: The objectives of this narrative review are to describe (1) the evidence for interventions addressing four key issues affecting female sexual health in cancer populations (ie, low sexual desire, vulvovaginal symptoms, negative body image, and sexual partner relationships) that are ready or nearly ready for integration into practice and (2) the current state of patient-provider sexual health communication related to female sexual health as these findings could have implications for integrating sexual health into practice., Methods: A narrative review of recent intervention evidence for female cancer survivors' sexual health was conducted., Results: Strong evidence was found for behavioral interventions, such as psychosexual counseling and psychoeducation to treat concerns related to sexual health, including desire, body image, and sexual partner relationships. For partnered female survivors, couple-based psychosexual interventions have been found to be effective. There are no proven pharmacologic treatments for sexual-related concerns other than for vulvovaginal atrophy in female cancer survivors. Vaginal nonhormonal and low-dose hormonal agents are effective remedies for vulvovaginal symptoms. Laser treatment has not yet been fully evaluated. Sexual partners are a critical context for sexual health. Despite much need, discussions around this topic continue to be relatively infrequent. Recent technology-based interventions show promise in improving discussions around sexual health., Conclusion: Effective interventions exist for many sexual health challenges for female survivors although more high-quality intervention research, particularly multimodal interventions, is needed. Many of the effective interventions are nonpharmacologic, and thus, evaluation of the use of digital delivery to improve access to these interventions is needed. Cancer care delivery research is urgently needed to translate existing effective interventions into practice, including strategies to improve patient-provider communication around this topic.

Purpose: Paclitaxel is associated with an acute pain syndrome (P-APS- and chronic chemotherapy-induced peripheral neuropathy (CIPN). P-APS is associated with higher risk of CIPN. Omega-3 fatty acids have well-established anti-inflammatory and neuroprotective properties. The primary purpose of this pilot study was to assess whether omega-3 fatty acids could decrease P-APS and thus CIPN., Methods: Patients scheduled to receive weekly paclitaxel for breast cancer were randomized to receive 4 g of omega-3 acid ethyl esters (Lovaza) or placebo, beginning 1 week prior and continued until paclitaxel was stopped. Patients completed acute pain questionnaires at baseline, daily after each treatment, and 1 month after completion of therapy., Results: Sixty patients (49 evaluable) were randomized to treatment versus placebo. Seventeen (68.0%) patients receiving the omega-3 fatty acids intervention experienced P-APS, compared to 15 (62.5%) of those receiving placebo during the first week of treatment (p = 0.77). Over the full 12-week study, 21 (84.0%) patients receiving the omega-3 fatty acid intervention experienced P-APS, compared to 21 (87.5%) of those receiving placebo (p = 1.0). Secondary outcomes suggested that those in the intervention arm used more over-the-counter analgesics (OR: 1.65, 95% CI: 0.72-3.78, p = 0.23), used more opiates (OR: 2.06, 95% CI: 0.55-7.75, p = 0.28), and experienced higher levels of CIPN (12.8, 95% CI: 7.6-19.4 vs. 8.4, 95% CI: 4.6-13.2, p = 0.21)., Conclusions: The results of this pilot study do not support further study of the use of omega-3 fatty acids for the prevention of the P-APS and CIPN., Trial Registration: Number: NCT01821833., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Large segments of the US population do not receive quality cancer care due to pervasive and systemic inequities, which can increase morbidity and mortality. Multicomponent, multilevel interventions can address inequities and improve care, but only if they reach communities with suboptimal access. Intervention studies often underenroll individuals from historically excluded groups., Methods: The Alliance to Advance Patient-Centered Cancer Care includes 6 grantees across the United States who implemented unique multicomponent, multilevel intervention programs with common goals of reducing disparities, increasing engagement, and improving the quality of care for targeted populations. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework informed the evaluation efforts across sites. Each Alliance site identified their intended populations, which included underrepresented minorities (eg, Black and Latinx persons), individuals who prefer a language other than English, and rural residents. We evaluated the demographic characteristics of participants to determine program reach., Results: Between 2018 and 2020, a total of 2,390 of 5,309 potentially eligible participants were enrolled across the 6 sites. The proportion of enrolled individuals with selected characteristics included 38% (n=908) Black adults, 24% (n=574) Latinx adults, 19% (n=454) preferring a language other than English, and 30% (n=717) rural residents. The proportion of those enrolled who were the intended population was commensurate to the proportion with desired characteristics in those identified as potentially eligible., Conclusions: The grantees met or exceeded enrollments from their intended populations who have been underserved by quality cancer care into patient-centered intervention programs. Intentional application of recruitment/engagement strategies is needed to reach individuals from historically underserved communities.

Background: The Roadmap mobile health (mHealth) app was developed to provide health-related quality of life (HRQOL) support for family caregivers of patients with cancer., Methods: Eligibility included: family caregivers (age ≥18 years) who self-reported as the primary caregiver of their pediatric patient with cancer; patients (age ≥5 years) who were receiving cancer care at the University of Michigan. Feasibility was calculated as the percentage of caregivers who logged into ONC Roadmap and engaged with it at least twice weekly for at least 50% of the 120-day study duration. Feasibility and acceptability was also assessed through a Feasibility and Acceptability questionnaire and the Mobile App Rating Scale to specifically assess app-quality. Exploratory analyses were also conducted to assess HRQOL self- or parent proxy assessments and physiological data capture., Results: Between September 2020-September 2021, 100 participants (or 50 caregiver-patient dyads) consented and enrolled in the ONC Roadmap study for 120-days. Feasibility of the study was met, wherein the majority of caregivers (N=32; 65%) logged into ONC Roadmap and engaged with it at least twice weekly for at least 50% of the study duration (defined a priori in the Protocol). The Feasibility and Acceptability questionnaire responses indicated that the study was feasible and acceptable with the majority (>50%) reporting Agree or Strongly Agree with positive Net Favorability [( Agree + Strongly Agree ) - ( Disagree + Totally Disagree )] in each of the domains (e.g., Fitbit use, ONC Roadmap use, completing longitudinal assessments, engaging in similar future study, study expectations). Improvements were seen across the majority of the mental HRQOL domains across all groups; even though underpowered, there were significant improvements in caregiver-specific aspects of HRQOL and anxiety and in depression and fatigue for children (ages 8-17 years), and a trend toward improvement in depression for children ages 8-17 years and in fatigue for adult patients., Conclusions: This study supports that mHealth technology may be a promising platform to provide HRQOL support for caregivers of pediatric patients with cancer. Importantly, the findings suggest that the study protocol was feasible, and participants were favorable to participate in future studies of this intervention alongside routine cancer care delivery., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-22-24/coif). CNN is supported by an NIH/NCI T32 Training Grant (T32CA236621). JPT reports that the analytic work for this study was supported by the National Center for Advancing Translational Sciences (NCATS Grant Number: UL1TR002240) for the Michigan Institute for Clinical and Health Research. JAM is supported as a research staff member on HL146354 (Roadmap mHealth Study). AH, NEC, DLB, DAH report that being Co-I of National Institute of Health/National Heart, Lung, and Blood Institute grant (1R01HL146354). SWC reports that this work was supported by an American Society of Hematology Bridge Grant and National Institute of Health/National Heart, Lung, and Blood Institute grant (1R01HL146354) and the Edith S. Briskin and Shirley K Schlafer Foundation (SWC). SWC is supported by grants 1R01HL146354 and K24HL156896. The other authors have no conflicts of interest to declare., (2023 mHealth. All rights reserved.)

Background: Head and neck cancer (HNC) and associated treatments have significant long-term and late adverse effects that can impair function. Therefore, there is a need for reliable common metrics to assess function in HNC that limit participant burden and are cost-effective and easy to use in clinical settings., Objective: The aim of this study was to assess the feasibility of using the Fitbit Zip, NIH Toolbox, and REDCap electronic data collection tool to measure function and symptoms in individuals with HNC and to explore preliminary findings., Methods: A prospective descriptive design with a total of 16 participants was used to assess function and symptoms pretreatment to 3 months post treatment initiation., Results: The enrollment rate was 49%, the retention rate was 81%, and the Fitbit Zip adherence rate was 86%. Exploratory analyses suggested a possible decline in physical activity and worsening symptom burden alongside improved attention and cognitive flexibility abilities ( P ≤ .05). There were no differences in strength, functional mobility, information processing, or perceived attentional function., Conclusion: The results of this study suggest that use of the Fitbit Zip, NIH Toolbox, and REDCap data collection tool in HNC is feasible. Exploratory analyses suggest that the Fitbit Zip may be a sensitive measure of physical activity in HNC., Implications for Practice: This study provides preliminary evidence for metrics that could be used in the clinical settings to assess function and symptom distress in HNC. Integration of these measures, upon further validation, could help providers better identify patients in need of intervention., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: More than 60% of cancer cases occur in older adults, and many are treated with oral anticancer agents. Yet, the treatment tolerability in older adults has not been fully understood due to their underrepresentation in oncology clinical trials, creating challenges for treatment decision-making and symptom management. The objective of this study was to investigate the tolerance of capecitabine, an example of oral chemotherapy, among older adults with cancer and explore factors associated with capecitabine-related side effects and treatment changes, to enhance supportive care., Methods: A secondary analysis used combined data from electronic health records and a pilot study of patient-reported outcomes, with a total of 97 adult patients taking capecitabine during 2016-2017, including older adult patients aged 65 years or older (n = 43). The data extracted included patient socio-demographics, capecitabine information, side effects, and capecitabine treatment changes (dose reductions and dose interruptions). Bivariate correlations, negative binomial regression, and multiple linear regression were conducted for data analysis., Results: Older adults were more likely to experience fatigue (86% vs. 51%, p = .001) and experienced more severe fatigue (β = 0.44, p = 0.03) and hand-foot syndrome (HFS) (β = 1.15, p = 0.004) than younger adults. The severity of fatigue and HFS were associated with the number of outpatient medications (β = 0.06, p = 0.006) and the duration of treatment (β = 0.50, p = 0.009), respectively. Correlations among side effects presented different patterns between younger and older adults. Although more older adults experienced dose reductions (21% vs. 13%) and dose interruptions (33% vs. 28%) than younger adults, the differences were not statistically different. Female sex, breast cancer diagnosis, capecitabine monotherapy, and severe HFS were found to be associated with dose reductions (p-values < 0.05)., Conclusions: Older adults were less likely to tolerate capecitabine treatment and had different co-occurring side effects compared to younger adults. While dose reductions are common among older adults, age 65 years or older may not be an independent factor of treatment changes. Other socio-demographic and clinical factors may be more likely to be associated. Future studies can be conducted to further explore older adults' tolerance to a variety of oral anticancer agents to generate more evidence to support optimal treatment decision-making and symptom management., (© 2022. The Author(s).)

Sexuality is an important component of holistic quality of life, and myocardial infarction (MI) negatively influences many aspects of sexuality, including sexual function. However, there is limited literature that examines sexuality beyond the most basic physical components. This pilot study aimed to describe the relationships between the physical, psychologic, and social domains of holistic sexuality at an early timepoint post-MI. Adult men post-MI were mailed self-report surveys at 2 weeks post discharge. Physical domains of sexuality were measured with the arousal, orgasm, erection, lubrication, and pain subscales of the Male Sexual Function Index (MSFI). The social domain utilized the sexual satisfaction subscale of the MSFI. The psychologic domain included the desire subscale of the MSFI and sexual fear (Multidimensional Sexuality Questionnaire). Spearman correlations were estimated to examine associations among the different measurement subscales. Twenty-four men post-MI were analyzed. Average scores on the MSFI were 9.2 ( SD 7.7). Desire and satisfaction were the highest scoring subscales among men when compared with other subscales (i.e. erection, lubrication). There was minimal evidence supporting a relationship between sexual fear and function. Additional research is also needed with larger samples, and among women post-MI.

Background: Six multidisciplinary cancer centers were selected and funded by the Merck Foundation (2017-2021) to collaborate in the Alliance to Advance Patient-Centered Cancer Care ("Alliance"), an initiative to improve patient access, minimize health disparities, and enhance the quality of patient-centered cancer care. These sites share their insights on implementation and expansion of their patient navigation efforts., Methods: Patient navigation represents an evidence-based health care intervention designed to enhance patient-centered care and care coordination. Investigators at 6 National Cancer Institute-designated cancer centers outline their approaches to reducing health care disparities and synthesize their efforts to ensure sustainability and successful transferability in the management of patients with cancer and their families in real-world health care settings., Results: Insights are outlined within the context of patient navigation program effectiveness and supported by examples from Alliance cancer center sites: 1) understand the patient populations, particularly underserved and high-risk patients; 2) capitalize on the existing infrastructure and institutional commitment to support and sustain patient navigation; and 3) build capacity by mobilizing community support outside of the cancer center., Conclusions: This process-level article reflects the importance of collaboration and the usefulness of partnering with other cancer centers to share interdisciplinary insights while undergoing intervention development, implementation, and expansion. These collective insights may be useful to staff at other cancer centers that look to implement, enhance, or evaluate the effectiveness of their patient navigation interventions., (© 2022 American Cancer Society.)

Background: Myocardial infarction (MI) may decrease sexual function and satisfaction in men and can be influenced by anxiety, depression, and sexual fear. However, few studies have examined short-term changes in sexual function over time in a post-MI population. This study aimed to longitudinally describe changes in sexual function and satisfaction in a sample of men post-MI., Methods: Eighteen patients were recruited from a Midwestern hospital. Surveys were mailed two weeks and three months post discharge. Sexual function was measured with the Male Sexual Function Index. Other variables collected included sexual fear (Multidimensional Sexuality Questionnaire), anxiety and depressive symptoms (Patient-Reported Outcomes Measurement Information System Anxiety and Depression 4a), and use of coping strategies (Coping Strategy Indicator)., Results: Sexual function scores increased in the entire sample from 8.9 (SD 7.3) at two weeks to 14.6 (SD 8.9) at three months (18.8% improvement, p= 0.04). Men who were sexually active improved their scores by 27.3% ( p= 0.01), while those who were not sexually active decreased their scores by 2.3% ( p= 0.5). Depressive symptoms and anxiety scores were low and largely stable across timepoints, though there were some improvements among men who were sexually active compared to those who were not. Decreased utilization of avoidance coping strategies was reported in sexually active versus inactive men., Conclusion: While sexual function improved within a short-time period post discharge among sexually active men post-MI, further research is needed with a larger sample to understand these changes across a longer period. Additional research is also warranted to examine any potential influence of psychosocial predictors., Competing Interests: Conflicts of interest/Competing interests None.

Purpose: Because of the negative impact of cancer treatment on female sexual function, effective treatments are warranted. The purpose of this multisite study was to evaluate the ability of two dose levels of extended-release bupropion, a dopaminergic agent, to improve sexual desire more than placebo at 9 weeks, measured by the desire subscale of the Female Sexual Function Index (FSFI), and to evaluate associated toxicities., Methods: Postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy, were eligible. Women were randomly assigned to receive 150 mg or 300 mg once daily of extended-release bupropion or a matching placebo. t -tests were performed on the FSFI desire subscale to evaluate whether there was a significantly greater change from baseline to 9 weeks between placebo and each bupropion arm as the primary end point. Sixty-two patients per arm provided 80% power using a one-sided t -test., Results: Two hundred thirty women were randomly assigned from 72 institutions through the NRG Oncology NCORP network. At 9 weeks, there were no statistically significant differences in change of the desire subscale scores between groups; participants in all three arms reported improvement. The mean changes for each arm were placebo 0.62 (standard deviation [SD] = 1.18), 150-mg once daily bupropion 0.64 (SD = 0.95), and 300-mg once daily bupropion 0.60 (SD = 0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups., Conclusion: Bupropion was not more effective than placebo in improving the desire subscale of the FSFI. Subscale and total scores of the FSFI demonstrated dysfunction throughout the 9 weeks of the study. More research is needed to support sexual function in female cancer survivors., Competing Interests: Debra L. BartonResearch Funding: Merck Stephanie L. PughResearch Funding: Pfizer (Inst), Millennium (Inst) Patricia A. GanzLeadership: Intrinsic LifeSciences (I)Stock and Other Ownership Interests: Xenon Pharma (I), Intrinsic LifeSciences (I), Teva, Novartis, Merck, Johnson & Johnson, Pfizer, GlaxoSmithKline, Abbott LaboratoriesConsulting or Advisory Role: InformedDNA, Vifor Pharma (I), Ambys Medicines (I), Global Blood Therapeutics (I), GlaxoSmithKline (I), Ionis Pharmaceuticals (I), Protagonist Therapeutics (I), Akebia Therapeutics (I), Regeneron (I), Sierra Oncology (I), Rockwell Medical Technologies Inc (I), Astellas Pharma (I), Gossamer Bio (I), American Regent (I), Disc Medicine (I), Blue Note Therapeutics (I), Grail (I)Research Funding: Blue Note Therapeutics (Inst)Patents, Royalties, Other Intellectual Property: Related to iron metabolism and the anemia of chronic disease, UpToDate royalties for section editor on survivorshipTravel, Accommodations, Expenses: Intrinsic LifeSciences (I) Steven C. PlaxeStock and Other Ownership Interests: Pfizer, Merck, Zimmer Biomet, GlaxoSmithKline, AstraZeneca, Bristol Myers Squibb/Pfizer, Johnson & Johnson/JanssenResearch Funding: Endocyte, Incyte, MedImmune, Novartis, Pfizer, Janssen Oncology, BIND Therapeutics, PharmaMar, AstraZeneca, Kevelt, Millennium, Tesaro Bridget F. KoontzEmployment: GenesisCareLeadership: GenesisCareConsulting or Advisory Role: Blue Earth Diagnostics, Myovant Sciences, Rythera TherapeuticsResearch Funding: Janssen, Merck, Blue Earth DiagnosticsPatents, Royalties, Other Intellectual Property: Demos Publishing Matthew L. HillStock and Other Ownership Interests: AstraZeneca, Newlink Genetics, Kazia Therapeutics, Leap Therapeutics, OncoSec, MEI Pharma, PLx Pharma, Radius Health, Crispr Therapeutics, Cassava SciencesOpen Payments Link: https://openpaymentsdata.cms.gov/physician/820072 Carolyn Y. MullerResearch Funding: AstraZeneca, Genmab, VBL Therapeutics, Roche/Genentech, TapImmune Inc, Linnaeus Therapeutics, Agenus, Incyte, MerckPatents, Royalties, Other Intellectual Property: Have a pending patent on the cancer use for R-ketorolac—not yet its own new drugOther Relationship: NCI, Department of Defense Lisa A. KachnicConsulting or Advisory Role: New B InnovationResearch Funding: Varian Medical SystemsPatents, Royalties, Other Intellectual Property: UpToDateNo other potential conflicts of interest were reported.

Purpose: To update recommendations of the ASCO systemic therapy for hormone receptor (HR)-positive metastatic breast cancer (MBC) guideline., Methods: An Expert Panel conducted a systematic review to identify new, potentially practice-changing data., Results: Fifty-one articles met eligibility criteria and form the evidentiary basis for the recommendations., Recommendations: Alpelisib in combination with endocrine therapy (ET) should be offered to postmenopausal patients, and to male patients, with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA -mutated, ABC, or MBC following prior endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Clinicians should use next-generation sequencing in tumor tissue or cell-free DNA in plasma to detect PIK3CA mutations. If no mutation is found in cell-free DNA, testing in tumor tissue, if available, should be used as this will detect a small number of additional patients with PIK3CA mutations. There are insufficient data at present to recommend routine testing for ESR1 mutations to guide therapy for HR-positive, HER2-negative MBC. For BRCA1 or BRCA2 mutation carriers with metastatic HER2-negative breast cancer, olaparib or talazoparib should be offered in the 1st-line through 3rd-line setting. A nonsteroidal aromatase inhibitor (AI) and a CDK4/6 inhibitor should be offered to postmenopausal women with treatment-naïve HR-positive MBC. Fulvestrant and a CDK4/6 inhibitor should be offered to patients with progressive disease during treatment with AIs (or who develop a recurrence within 1 year of adjuvant AI therapy) with or without one line of prior chemotherapy for metastatic disease, or as first-line therapy. Treatment should be limited to those without prior exposure to CDK4/6 inhibitors in the metastatic setting.Additional information can be found at www.asco.org/breast-cancer-guidelines., Competing Interests: Reprint Requests: 2318 Mill Road, Suite 800, Alexandria, VA 22314; guidelines@asco.org Debra L. BartonResearch Funding: Merck Lesley J. FallowfieldHonoraria: Voluntis, Genomic Health, NanoString Technologies, Novartis, Pfizer, MSD, Novartis, AbbVie, Clovis OncologyConsulting or Advisory Role: Puma Biotechnology, Voluntis, AstraZeneca, Takeda, Genomic Health/Exact Sciences, Lilly, Seagen, RocheResearch Funding: Bristol Myers Squibb, Novartis, LillyTravel, Accommodations, Expenses: Genomic Health Stephen R. D. JohnstonHonoraria: Pfizer, Novartis, Eisai, AstraZeneca, Roche, LillyConsulting or Advisory Role: Lilly, Puma Biotechnology, Novartis, PfizerResearch Funding: Pfizer, Puma BiotechnologyExpert Testimony: Novartis Jennifer K. LittonHonoraria: UpToDateConsulting or Advisory Role: Pfizer, AstraZeneca, Medivation/Pfizer, Ayala PharmaceuticalsSpeakers' Bureau: Physicans' Education Resource, UpToDate, Med Learning Group, Medscape, Prime Oncology, Clinical Care Options, MedpageResearch Funding: Genentech, Pfizer, EMD Serono, AstraZeneca, Zenith Epigenetics, MerckPatents, Royalties, Other Intellectual Property: UptoDateTravel, Accommodations, Expenses: Physicans' Education Resource, Med Learning Group, Medscape, Clinical Care OptionsOther Relationship: Medivation/Pfizer Praveen VikasStock and Other Ownership Interests: Moderna Therapeutics, NovavaxResearch Funding: Sanofi Rachel L. YungResearch Funding: Novartis, Odonate Therapeutics, American Cancer Society/Pfizer Hope S. RugoHonoraria: Puma Biotechnology, MylanConsulting or Advisory Role: SamsungResearch Funding: Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Lilly, Genentech, Merck, Immunomedics, Odonate Therapeutics, Daiichi Sankyo, Seattle Genetics, Sermonix Pharmaceuticals, AstraZenecaTravel, Accommodations, Expenses: Pfizer, Novartis, Macrogenics, Mylan, Daiichi Sankyo, AstraZeneca Spain, MerckOpen Payments Link: https://openpaymentsdata.cms.gov/summaryNo other potential conflicts of interest were reported.

Background: Sexual dysfunction often persists among men post-myocardial infarction (MI). While some cross-sectional and longitudinal research has been conducted, there are still no known modifiable targets for intervention. This pilot study aimed to model hypothesized predictive factors of higher sexual function in a cohort of men post-MI., Methods: In a longitudinal study design, sexual function (Male Sexual Function Index), sexual fear (Multidimensional Sexuality Questionnaire), anxiety and depressive symptoms (Patient-Reported Outcomes Measurement Information System), and utilization of coping strategies (Coping Strategy Indicator) data were collected at two weeks and three months post discharge for MI. Spearman correlations were estimated to examine associations among MSFI scores with the selected predictors at two weeks and three months. Linear regression models were conducted for sexual function while controlling for age., Results: Fourteen men post-MI were analyzed. The average age of the sample was 59.79 years, 78.6% were married, and all were self-reported White race. Sexual fear and utilization of problem-solving and support-seeking coping strategies were moderately correlated with MSFI scores at three months. Increased use of problem-solving and support-seeking coping strategies were associated with increased sexual function at three months (support-seeking coping 1.47, p <0.01; problem-solving coping 0.95, p =0.02)., Conclusions: Based on these preliminary findings, utilization of coping strategies may predict increased function score over three months. However, additional studies are needed to further examine these hypothesized relationships with a larger more diverse sample. Additional studies are needed of predictors of sexual function among women post-MI.

Few studies have directly targeted nonparticipants in colorectal cancer screening to identify effective engagement strategies. We undertook a randomized controlled trial that targeted nonparticipants in a previous trial of average-risk subjects which compared participation rates for mailed invitations offering a fecal test, a blood test or a choice of either. Nonparticipants ( n = 899) were randomized to be offered a kit containing a fecal immunochemical test (FIT), directions on how to arrange a blood DNA test, or the option of doing either. Screening participation was assessed 12 weeks after the offer. To assess the cognitive and attitudinal variables related to participation and invitee choice, invitees were surveyed after 12 weeks, and associations were investigated using multinomial logistic regression. Participation rates were similar between groups ( P = 0.88): 12.0% for FIT (35/292), 13.3% for the blood test (39/293), and 13.4% for choice (39/290). Within the choice group, participation was significantly higher with FIT (9.7%, 28/290) compared with the blood test (3.8%, 11/290, P = 0.005). The only variable significantly associated with participation was socioeconomic status when offered FIT, and age when offered choice but there was none when offered the blood test. Survey respondents indicated that convenience, time-saving, comfort, and familiarity were major influences on participation. There was no clear advantage between a fecal test, blood test, or choice of test although, when given a choice, the fecal test was preferred. Differences in variables associated with participation according to invitation strategy warrant consideration when deciding upon an invitation strategy for screening nonparticipants. PREVENTION RELEVANCE: This trial of screening for those at average risk for colorectal cancer targeted past fecal-test nonparticipants and compared participation rates for mailed invitations offering a fecal test, blood test, or choice of either. Although there was no clear advantage between strategies, factors associated with participation differed between each strategy., (©2021 American Association for Cancer Research.)

Objectives: The objectives were to compare patients with and without cancer who sought an integrative health (IH) consult and reasons for seeking a consult., Design: Descriptive cross-sectional study that employed a secondary analysis of an integrative health database supplemented by a retrospective medical record review., Setting/location: Integrative Medicine and Health program in a Southwestern United States academic medical center., Subjects: Eight hundred thirty-nine adults over the age of 18 seeking IH consultation., Results: The number of complementary therapies reported prior to consult were not significantly different between groups. The most reported complementary therapies used by cancer survivors were multivitamins, exercise, and turmeric. Patients without cancer reported significantly higher pain levels than cancer survivors. Cancer survivors reported significantly higher energy, sleep levels, overall health, spiritual wellbeing, and significantly better relationships compared to patients without cancer. Cancer survivors reported fatigue and cancer as the top reasons for IH consult., Conclusion: Participants without cancer reported higher levels of pain and lower levels of energy, sleep, overall health, spiritual wellbeing, and relationships compared to cancer survivors. However, cancer survivors still reported levels of unmanaged symptoms. Complementary therapy use prior to IMH consult was similar between groups; however, IMH providers recommended more treatments for patients without cancer. Our results highlight that more evidence is needed to guide IMH recommendations, especially for cancer survivors who may still be in treatment. Additionally, our results support evidence-based recommendations that all cancer survivors should be assessed for complementary therapy use and provided counseling by qualified providers on their advantages and limitations.

Purpose: Fatigue and anxiety are common and significant symptoms reported by cancer patients. Few studies have examined the trajectory of multidimensional fatigue and anxiety, the relationships between them and with quality of life., Methods: Breast cancer patients (n = 580) from community oncology clinics and age-matched controls (n = 364) completed fatigue and anxiety questionnaires prior to chemotherapy (A1), at chemotherapy completion (A2), and six months post-chemotherapy (A3). Linear mixed models (LMM) compared trajectories of fatigue /anxiety over time in patients and controls and estimated their relationship with quality of life. Models adjusted for age, education, race, BMI, marital status, menopausal status, and sleep symptoms., Results: Patients reported greater fatigue and anxiety compared to controls at all time points (p's < 0.001, 35% clinically meaningful anxiety at baseline). From A1 to A2 patients experienced a significant increase in fatigue (β = 8.3 95%CI 6.6,10.0) which returned to A1 values at A3 but remained greater than controls' (p < 0.001). General, mental, and physical fatigue subscales increased from A1 to A2 remaining significantly higher than A1 at A3 (p < 0.001). Anxiety improved over time (A1 to A3 β =  - 4.3 95%CI -2.6,-3.3) but remained higher than controls at A3 (p < 0.001). Among patients, fatigue and anxiety significantly predicted one another and quality of life. Menopausal status, higher BMI, mastectomy, and sleep problems also significantly predicted change in fatigue., Conclusion: Breast cancer patients experience significant fatigue and anxiety up to six months post-chemotherapy that is associated with worse quality of life. Future interventions should simultaneously address anxiety and fatigue, focusing on mental and physical fatigue subdomains.

Purpose: Sleep disturbance is a prevalent problem for cancer survivors and effective behavioral treatments are not widely used for this population. This study evaluated home-based sleep interventions based on cognitive behavioral therapy for insomnia (CBT-I)., Methods: This phase II randomized controlled trial evaluated two manualized interventions over 7 weeks. The intervention group received sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording. The control group was similar, but without sleep restriction and used audio recordings of bedtime short stories instead of imagery. Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7 days. Patients with diagnoses of sleep or mental health disorders were excluded. The primary endpoint was change in time to fall asleep or falling back to sleep after awakening, from baseline to week 7. Two-sample T tests evaluated differences between arms for this endpoint., Results: Ninety-three of 168 planned participants were enrolled from 20 institutions. The study closed early for poor accrual. Baseline time to sleep was 45 min and 52 min for the intervention and control group, respectively. At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85). Secondary outcomes improved in both groups with no significant differences between arms., Conclusions: Improvement in sleep outcomes in both arms was consistent with other CBT-I interventions delivered through alternative approaches to provider-delivered therapy. More research on optimal scalable delivery of CBT-I is needed., Clinical Relevance: This study supports the effectiveness of CBT-I based behavioral interventions for sleep but also the need for better delivery methods to improve uptake and effect size., Trial Registration: ClinicalTrials.gov identifier: NCT00993928.

Background: Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory., Objective: This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation., Methods: The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records., Results: We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app., Conclusions: This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes., Trial Registration: ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844., International Registered Report Identifier (irrid): PRR1-10.2196/19288., (©Michelle Rozwadowski, Manasa Dittakavi, Amanda Mazzoli, Afton L Hassett, Thomas Braun, Debra L Barton, Noelle Carlozzi, Srijan Sen, Muneesh Tewari, David A Hanauer, Sung Won Choi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.09.2020.)

Context: Cancer-related fatigue (CRF) is one of the most common symptoms experienced by cancer patients after hematopoietic cell transplantation (HCT). Yoga is an approach with supportive evidence to improve CRF in different cancer populations, but to our knowledge, it has not been tested in an adult HCT population., Objectives: The aim of this study was to evaluate the feasibility of a yoga intervention offered to adult HCT survivors with moderate-to-severe CRF., Methods: This feasibility study used a single-arm, pretest-posttest design. Adult HCT survivors were enrolled in a six-week restorative yoga intervention that consisted of a one-hour once-weekly class with twice-weekly home practice using a DVD., Results: Twenty participants (13 women and seven men) enrolled in this study with a mean age of 51 years (SD = 12.5). The sample consisted of 19 allogeneic HCT survivors, seven of whom had a history of acute graft-vs.-host disease (GVHD), six with active, extensive chronic GVHD, and one autologous HCT survivor. The accrual acceptance rate was 23.2% (20/86 HCT survivors) and retention rate was 60% (12/20). Overall adherence was 45.4%. No adverse events were reported., Conclusion: The results of this study suggest that a restorative yoga intervention in adult HCT survivors is safe and feasible. The incidence of GVHD may have impacted adherence. Strategies to improve accrual acceptance, retention, and adherence are needed., (Copyright © 2019 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: There are growing concerns about patients' adherence to oral anticancer agents (OAAs), and the need for patients to engage in self-management of OAA-related side effects. We assessed associations among adherence, severity of side effects, and effectiveness of self-management of side effects in patients taking capecitabine., Methods: Adherence to capecitabine at 6 weeks was measured by the Medication Event Monitoring System among 50 patients with gastrointestinal cancers. Severity of side effects related to capecitabine and effectiveness of self-management of side effects were captured using the Modified Self-Care Diary at the time of enrollment and weekly for 6 weeks. Spearman's correlation, Mann-Whitney U -tests, and multiple linear regression were conducted, p <0.05., Results: Overall mean adherence rate was 85.4±14.1%. Adherence rate was not significantly correlated to the mean severity of total side effects at any time point and was correlated with the mean effectiveness of self-management of total side effects only at week 2 ( rho =0.29, p =0.04). However, adherence rate was associated with the mean severity of one specific side effect, diarrhea, at 6 weeks ( rho =0.36, p =0.01) and marginally correlated to the mean effectiveness of self-management of diarrhea at 6 weeks ( rho =0.28, p =0.05). Mean severity of diarrhea at 6 weeks was an independent predictor of adherence rate ( b =4.97, p =0.01), with the control of age ( b =0.52, p =0.002), number of outpatient medications ( b =1.12, p =0.007), health literacy ( b =2.53, p =0.04), diagnosis of colorectal cancer ( b =11.6, p =0.03), and capecitabine in combination with other chemotherapies ( b =16.8, p =0.001) in the model., Conclusion: This pilot study suggests ongoing examination of both severity and effectiveness of self-management of side effects in future studies of adherence to OAAs is merited. There is a need for future studies with larger sample sizes that explore the complex relationships among adherence, severity of side effects, and effectiveness of self-management of side effects in OAA therapy., Competing Interests: Karen B Farris reports personal fees from QuiO, outside the submitted work. The authors report no other conflicts of interest to this work., (© 2019 Jiang et al.)

Purpose: This article outlines how current nursing research can utilize technology to advance symptom and self-management science for precision health and provides a roadmap for the development and use of technologies designed for this purpose., Approach: At the 2018 annual conference of the National Institute of Nursing Research (NINR) Research Centers, nursing and interdisciplinary scientists discussed the use of technology to support precision health in nursing research projects and programs of study. Key themes derived from the presentations and discussion were summarized to create a proposed roadmap for advancement of technologies to support health and well-being., Conclusions: Technology to support precision health must be centered on the user and designed to be desirable, feasible, and viable. The proposed roadmap is composed of five iterative steps for the development, testing, and implementation of technology-based/enhanced self-management interventions. These steps are (a) contextual inquiry, focused on the relationships among humans, and the tools and equipment used in day-to-day life; (b) value specification, translating end-user values into end-user requirements; (c) design, verifying that the technology/device can be created and developing the prototype(s); (d) operationalization, testing the intervention in a real-world setting; and (e) summative evaluation, collecting and analyzing viability metrics, including process data, to evaluate whether the technology and the intervention have the desired effect., Clinical Relevance: Interventions using technology are increasingly popular in precision health. Use of a standard multistep process for the development and testing of technology is essential., (© 2019 Sigma Theta Tau International.)

Background: Sexual dysfunction, fueled by body image stress, is prevalent in women with a history of breast or gynecologic cancer. Preliminary data support that mind-body connections may improve sexual health outcomes through improving body image., Objective: This randomized controlled trial compared hypnosis to progressive muscle relaxation (PMR). The primary outcome was body image at week 6 as measured by the Impact of Treatment Scale for women who have or have had breast or gynecologic cancer., Interventions/methods: Consented participants were randomized 2:1 to hypnosis or PMR. Both arms consisted of three face-to-face sessions delivered by a trained therapist. Sessions were every 2 weeks for 6 weeks; participants practiced at home between sessions using an audio recording., Results: Eighty-seven women were randomized, 59 to hypnosis and 28 to PMR. Both groups reported significant improvements on body image over time (within group effect size Cohen's d = 0.49-0.75) with no significant difference between groups (p = 0.15). Secondary outcomes were not significantly different between groups. The hypnosis group improved more in sexual satisfaction and sexual interest while the PMR group improved more in positive affect., Conclusions: Interventions facilitating mind-body connections such as hypnosis and PMR may help to improve body image. This study suggests that stress relieving strategies of hypnosis and PMR may contribute to providing a re-connection to one's body, improved positive affect, and overall better sexual health.

Cancer-related fatigue (CRF) is a common symptom for which cancer patients often use integrative and integrative therapies; however, evidence supporting these therapies is limited. The aim of this review is to provide evidence-based recommendations for integrative interventions during and after cancer treatment for CRF. These recommendations are based on a systematic literature review from 1990 through 2019. Cognitive behavior therapy plus hypnosis and American ginseng can be considered during active treatment, and acupressure, mindfulness-based cognitive therapy, and qigong/tai chi easy can be considered during posttreatment. Coenzyme Q10 and L-carnitine are not recommended during active-treatment. All other integrative therapies for CRF had insufficient evidence to make a recommendation. While there is increasing evidence for integrative therapies for CRF, because of lack of rigorous trials and replication, no therapies could be definitively recommended. Further rigorously designed integrative therapy research is needed and should consider implementation and dissemination.