17 results on '"Ligibel, J."'
Search Results
2. 2031O Randomized trial of a telephone-based weight loss intervention in overweight and obese patients (pts) with breast cancer (BC): The MEDEA trial
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Luis, I.V. Vaz, Di Meglio, A., Martin, E., Vanlemmens, L., Segura-Djezzar, C., Bouleuc, C., Tredan, O., Pistilli, B., Crane, T., Soldato, D., Charles, C., Barbier, A., Raynard, B., Mangin, A., Coquet, B., Jacob, G., Bonastre, J., Michiels, S., Chaltiel, D., and Ligibel, J.
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- 2023
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3. Early Implementation of Exercise to Facilitate Recovery After Breast Cancer Surgery: A Randomized Clinical Trial.
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Min J, Kim JY, Ryu J, Park S, Courneya KS, Ligibel J, Kim SI, and Jeon JY
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- Humans, Female, Middle Aged, Muscle Strength physiology, Adult, Quality of Life, Resistance Training, Shoulder Joint surgery, Shoulder Joint physiopathology, Breast Neoplasms surgery, Breast Neoplasms rehabilitation, Mastectomy rehabilitation, Range of Motion, Articular, Exercise Therapy methods, Recovery of Function
- Abstract
Importance: Recovery of shoulder function following breast cancer surgery is crucial for physical functioning and quality of life. While early implementation of shoulder rehabilitation exercises may enhance recovery, the optimal timing and exercise program remain unclear., Objective: To investigate whether an early exercise intervention, initiated 1 day postsurgery and continued for 1 month through subsequent visits, could improve shoulder range of motion (ROM) and strength in patients with breast cancer., Design, Setting, and Participants: A parallel-group, 2-arm randomized clinical trial was conducted between June 2020 and October 2021 at the Breast Cancer Center in Seoul, South Korea. Fifty-six patients (of 119 screened) with early-stage breast cancer who were scheduled for partial or total mastectomy were randomized into a tailored resistance exercise group (n = 28) or a usual care group (n = 28). Data were analyzed from November 2021 to June 2022., Interventions: The exercise intervention commenced 1 day postsurgery and consisted of 4 supervised exercise education sessions corresponding with surgeon visits and daily home-based exercises for the first postoperative month. Tailored programs, including stretching and strength exercises, were adjusted based on individual shoulder function recovery status., Main Outcomes and Measures: Primary end points were shoulder ROM and strength at 1 and 6 months postsurgery. Physical activity, body composition, and quality of life were assessed at 6 months., Results: Of 56 patients randomized (mean [SD] age, 50.3 [6.6] years), 54 completed the trial (96%), with 100% and 97% compliance to supervised and home-based exercise sessions, respectively. At 1 month postsurgery, 19 (67.9%) in the exercise group had fully recovered shoulder strength compared to 1 (3.6%) in the usual care group (P < .001). At 6 months, 22 (78.6%) in the exercise group had fully recovered shoulder ROM and 24 (85.7%) had fully recovered strength compared to 6 (21.4%) and 5 (17.9%), respectively, in the usual care group (P < .001). The exercise group exhibited less loss in muscle mass and improved physical activity and quality of life compared to the usual care group., Conclusion and Relevance: In this trial, 1-month tailored exercise program, initiated immediately after breast cancer surgery and supplemented with supervised sessions coinciding with surgeon visits, significantly improved shoulder function in patients with breast cancer., Trial Registration: WHO International Clinical Trials Registry identifier: KCT0006997.
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- 2024
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4. Abnormal vascular structure and function within brain metastases is linked to pembrolizumab resistance.
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Kim AE, Lou KW, Giobbie-Hurder A, Chang K, Gidwani M, Hoebel K, Patel JB, Cleveland MC, Singh P, Bridge CP, Ahmed SR, Bearce BA, Liu W, Fuster-Garcia E, Lee EQ, Lin NU, Overmoyer B, Wen PY, Nayak L, Cohen JV, Dietrich J, Eichler A, Heist R, Krop I, Lawrence D, Ligibel J, Tolaney S, Mayer E, Winer E, Perrino CM, Summers EJ, Mahar M, Oh K, Shih HA, Cahill DP, Rosen BR, Yen YF, Kalpathy-Cramer J, Martinez-Lage M, Sullivan RJ, Brastianos PK, Emblem KE, and Gerstner ER
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- Humans, Female, Male, Middle Aged, Aged, Antineoplastic Agents, Immunological therapeutic use, Magnetic Resonance Imaging, Adult, Prognosis, Immune Checkpoint Inhibitors therapeutic use, Neovascularization, Pathologic drug therapy, Neovascularization, Pathologic pathology, Follow-Up Studies, Antibodies, Monoclonal, Humanized therapeutic use, Brain Neoplasms drug therapy, Brain Neoplasms secondary, Brain Neoplasms diagnostic imaging, Drug Resistance, Neoplasm
- Abstract
Background: We recently conducted a phase 2 trial (NCT028865685) evaluating intracranial efficacy of pembrolizumab for brain metastases (BM) of diverse histologies. Our study met its primary efficacy endpoint and illustrates that pembrolizumab exerts promising activity in a select group of patients with BM. Given the importance of aberrant vasculature in mediating immunosuppression, we explored the relationship between immune checkpoint inhibitor (ICI) efficacy and vascular architecture in the hopes of identifying potential mechanisms of intracranial ICI response or resistance for BM., Methods: Using Vessel Architectural Imaging, a histologically validated quantitative metric for in vivo tumor vascular physiology, we analyzed dual-echo DSC/DCE MRI for 44 patients on trial. Tumor and peri-tumor cerebral blood volume/flow, vessel size, arterial and venous dominance, and vascular permeability were measured before and after treatment with pembrolizumab., Results: BM that progressed on ICI were characterized by a highly aberrant vasculature dominated by large-caliber vessels. In contrast, ICI-responsive BM possessed a more structurally balanced vasculature consisting of both small and large vessels, and there was a trend toward a decrease in under-perfused tissue, suggesting a reversal of the negative effects of hypoxia. In the peri-tumor region, the development of smaller blood vessels, consistent with neo-angiogenesis, was associated with tumor growth before radiographic evidence of contrast enhancement on anatomical MRI., Conclusions: This study, one of the largest functional imaging studies for BM, suggests that vascular architecture is linked with ICI efficacy. Studies identifying modulators of vascular architecture, and effects on immune activity, are warranted and may inform future combination treatments., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
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- 2024
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5. Design and Rationale of Prolonged Nightly Fasting for Multiple Myeloma Prevention (PROFAST): Protocol for a Randomized Controlled Pilot Trial.
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Lee DJ, O'Donnell EK, Raje N, Panaroni C, Redd R, Ligibel J, Sears DD, Nadeem O, Ghobrial IM, and Marinac CR
- Abstract
Background: Obesity is an established, modifiable risk factor of multiple myeloma (MM); yet, no lifestyle interventions are routinely recommended for patients with overweight or obesity with MM precursor conditions. Prolonged nightly fasting is a simple, practical dietary regimen supported by research, suggesting that the synchronization of feeding-fasting timing with sleep-wake cycles favorably affects metabolic pathways implicated in MM. We describe the design and rationale of a randomized controlled pilot trial evaluating the efficacy of a regular, prolonged nighttime fasting schedule among individuals with overweight or obesity at high risk for developing MM or a related lymphoid malignancy., Objective: We aim to investigate the effects of 4-month prolonged nightly fasting on body composition and tumor biomarkers among individuals with overweight or obesity with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or smoldering Waldenström macroglobulinemia (SWM)., Methods: Individuals with MGUS, SMM, or SWM aged ≥18 years and a BMI of ≥25 kg/m
2 are randomized to either a 14-hour nighttime fasting intervention or a healthy lifestyle education control group. Participants' baseline diet and lifestyle patterns are characterized through two 24-hour dietary recalls: questionnaires querying demographic, comorbidity, lifestyle, and quality-of-life information; and wrist actigraphy measurements for 7 days. Fasting intervention participants are supported through one-on-one telephone counseling by a health coach and automated SMS text messaging to support fasting goals. Primary end points of body composition, including visceral and subcutaneous fat (by dual-energy x-ray absorptiometry); bone marrow adiposity (by bone marrow histology); and tumor biomarkers, specifically M-proteins and serum free light-chain concentrations (by gel-based and serum free light-chain assays), are assessed at baseline and after the 4-month study period; changes therein from baseline are evaluated using a repeated measures mixed-effects model that accounts for the correlation between baseline and follow-up measures and is generally robust to missing data. Feasibility is assessed as participant retention (percent dropout in each arm) and percentage of days participants achieved a ≥14-hour fast., Results: The PROlonged nightly FASTing (PROFAST) study was funded in June 2022. Participant recruitment commenced in April 2023. As of July 2023, six participants consented to the study. The study is expected to be completed by April 2024, and data analysis and results are expected to be published in the first quarter of 2025., Conclusions: PROFAST serves as an important first step in exploring the premise that prolonged nightly fasting is a strategy to control obesity and obesity-related mechanisms of myelomagenesis. In evaluating the feasibility and impact of prolonged nightly fasting on body composition, bone marrow adipose tissue, and biomarkers of tumor burden, this pilot study may generate hypotheses regarding metabolic mechanisms underlying MM development and ultimately inform clinical and public health strategies for MM prevention., Trial Registration: ClinicalTrials.gov NCT05565638; http://clinicaltrials.gov/ct2/show/NCT05565638., International Registered Report Identifier (irrid): DERR1-10.2196/51368., (©David J Lee, Elizabeth K O'Donnell, Noopur Raje, Cristina Panaroni, Robert Redd, Jennifer Ligibel, Dorothy D Sears, Omar Nadeem, Irene M Ghobrial, Catherine R Marinac. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 11.03.2024.)- Published
- 2024
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6. A qualitative analysis of algorithm-based decision support usability testing for symptom management across the trajectory of cancer care: one size does not fit all.
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Yackel HD, Halpenny B, Abrahm JL, Ligibel J, Enzinger A, Lobach DF, and Cooley ME
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- Adult, Humans, User-Centered Design, User-Computer Interface, Algorithms, Cancer Survivors, Nurse Practitioners, Neoplasms diagnosis, Neoplasms therapy
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Background: Adults with cancer experience symptoms that change across the disease trajectory. Due to the distress and cost associated with uncontrolled symptoms, improving symptom management is an important component of quality cancer care. Clinical decision support (CDS) is a promising strategy to integrate clinical practice guideline (CPG)-based symptom management recommendations at the point of care., Methods: The objectives of this project were to develop and evaluate the usability of two symptom management algorithms (constipation and fatigue) across the trajectory of cancer care in patients with active disease treated in comprehensive or community cancer care settings to surveillance of cancer survivors in primary care practices. A modified ADAPTE process was used to develop algorithms based on national CPGs. Usability testing involved semi-structured interviews with clinicians from varied care settings, including comprehensive and community cancer centers, and primary care. The transcripts were analyzed with MAXQDA using Braun and Clarke's thematic analysis method. A cross tabs analysis was also performed to assess the prevalence of themes and subthemes by cancer care setting., Results: A total of 17 clinicians (physicians, nurse practitioners, and physician assistants) were interviewed for usability testing. Three main themes emerged: (1) Algorithms as useful, (2) Symptom management differences, and (3) Different target end-users. The cross-tabs analysis demonstrated differences among care trajectories and settings that originated in the Symptom management differences theme. The sub-themes of "Differences between diseases" and "Differences between care trajectories" originated from participants working in a comprehensive cancer center, which tends to be disease-specific locations for patients on active treatment. Meanwhile, participants from primary care identified the sub-theme of "Differences in settings," indicating that symptom management strategies are care setting specific., Conclusions: While CDS can help promote evidence-based symptom management, systems providing care recommendations need to be specifically developed to fit patient characteristics and clinical context. Findings suggest that one set of algorithms will not be applicable throughout the entire cancer trajectory. Unique CDS for symptom management will be needed for patients who are cancer survivors being followed in primary care settings., (© 2024. The Author(s).)
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- 2024
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7. Structural and functional vascular dysfunction within brain metastases is linked to pembrolizumab inefficacy.
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Kim AE, Lou KW, Giobbie-Hurder A, Chang K, Gidwani M, Hoebel K, Patel JB, Cleveland MC, Singh P, Bridge CP, Ahmed SR, Bearce BA, Liu W, Fuster-Garcia E, Lee EQ, Lin NU, Overmoyer B, Wen PY, Nayak L, Cohen JV, Dietrich J, Eichler A, Heist R, Krop I, Lawrence D, Ligibel J, Tolaney S, Mayer E, Winer E, Perrino CM, Summers EJ, Mahar M, Oh K, Shih HA, Cahill DP, Rosen BR, Yen YF, Kalpathy-Cramer J, Martinez-Lage M, Sullivan RJ, Brastianos PK, Emblem KE, and Gerstner ER
- Abstract
Structurally and functionally aberrant vasculature is a hallmark of tumor angiogenesis and treatment resistance. Given the synergistic link between aberrant tumor vasculature and immunosuppression, we analyzed perfusion MRI for 44 patients with brain metastases (BM) undergoing treatment with pembrolizumab. To date, vascular-immune communication, or the relationship between immune checkpoint inhibitor (ICI) efficacy and vascular architecture, has not been well-characterized in human imaging studies. We found that ICI-responsive BM possessed a structurally balanced vascular makeup, which was linked to improved vascular efficiency and an immune-stimulatory microenvironment. In contrast, ICI-resistant BM were characterized by a lack of immune cell infiltration and a highly aberrant vasculature dominated by large-caliber vessels. Peri-tumor region analysis revealed early functional changes predictive of ICI resistance before radiographic evidence on conventional MRI. This study was one of the largest functional imaging studies for BM and establishes a foundation for functional studies that illuminate the mechanisms linking patterns of vascular architecture with immunosuppression, as targeting these aspects of cancer biology may serve as the basis for future combination treatments.
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- 2023
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8. Exploring Young Adults' Perspectives of Participation in a Mindfulness-Based Music Therapy Intervention Before and During the COVID-19 Pandemic.
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Phillips CS, Bockhoff J, Berry DL, Buchbinder E, Frazier AL, LaCasce A, Ligibel J, Luskin MR, Woods H, and Knoerl R
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- Adolescent, Adult, Humans, Young Adult, Pandemics, Qualitative Research, COVID-19, Mindfulness methods, Music, Music Therapy
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Purpose: To explore adolescent and young adults' (AYAs) experiences with participation in a mindfulness-based music therapy intervention during cancer treatment before and during the COVID-19 pandemic. Methods: Sixteen young adults (20-39 years old) who received cancer treatment and participated in a mindfulness-based music therapy intervention for anxiety and stress were interviewed using a semistructured interview guide. Interviews were audio recorded and transcribed verbatim. The interview guide contained prompts about reasons for joining the study, usual coping strategies, experience with the in-person and virtual delivery formats of the intervention, and suggestions for improvement. Themes were derived from the data using inductive content analysis methods. Results: Findings from the interviews included the following: (1) virtual group participants reported difficulty finding a private place to attend the intervention sessions, (2) participants experienced a sense of relaxation in response to intervention participation, (3) in-person group participants felt a sense of connection to the music and their family members who were present during the intervention, while virtual group participants felt a sense of connection to mindfulness, (4) virtual group participants reported that practicing music and mindfulness together was synergistic, and (5) in-person intervention delivery was preferred to virtual intervention delivery. Conclusion: This study provides insight into the contextual factors that impact satisfaction with the intervention and the effect of the intervention on anxiety and stress. Overall, while virtual mindfulness-based music therapy delivery may be more feasible, there are still important advantages to in-person delivery that should be considered in the design of future mindfulness-based music therapy interventions. ClinicalTrials.gov Identifier: NCT03709225.
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- 2023
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9. Pembrolizumab in brain metastases of diverse histologies: phase 2 trial results.
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Brastianos PK, Kim AE, Giobbie-Hurder A, Lee EQ, Lin NU, Overmoyer B, Wen PY, Nayak L, Cohen JV, Dietrich J, Eichler A, Heist RS, Krop I, Lawrence D, Ligibel J, Tolaney S, Mayer E, Winer E, Bent B, de Sauvage MA, Ijad N, Larson JM, Marion B, Nason S, Murthy N, Ratcliff S, Summers EJ, Mahar M, Shih HA, Oh K, Cahill DP, Gerstner ER, and Sullivan RJ
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- Humans, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Combined Chemotherapy Protocols, Brain Neoplasms drug therapy, Brain Neoplasms secondary, Melanoma pathology
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Brain metastases (BMs) are an emerging challenge in oncology due to increasing incidence and limited treatments. Here, we present results of a single-arm, open-label, phase 2 trial evaluating intracranial efficacy of pembrolizumab, a programmed cell death protein 1 inhibitor, in 9 patients with untreated BMs (cohort A) and 48 patients with recurrent and progressive BMs (cohort B) across different histologies. The primary endpoint was the proportion of patients achieving intracranial benefit, defined by complete response, partial response or stable disease. The primary endpoint was met with an intracranial benefit rate of 42.1% (90% confidence interval (CI): 31-54%). The median overall survival, a secondary endpoint, was 8.0 months (90% CI: 5.5-8.7 months) across both cohorts, 6.5 months (90% CI: 4.5-18.7 months) for cohort A and 8.1 months (90% CI: 5.3-9.6 months) for cohort B. Seven patients (12.3%), encompassing breast, melanoma and sarcoma histologies, had overall survival greater than 2 years. Thirty patients (52%; 90% CI: 41-64%) had one or more grade-3 or higher adverse events that were at least possibly treatment related. Two patients had grade-4 adverse events (cerebral edema) that were deemed at least possibly treatment related. These results suggest that programmed cell death protein 1 blockade may benefit a select group of patients with BMs, and support further studies to identify biomarkers and mechanisms of resistance. ClinicalTrials.gov identifier: NCT02886585., (© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.)
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- 2023
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10. Exploring Influencing Factors of Anxiety Improvement Following Mindfulness-Based Music Therapy in Young Adults with Cancer.
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Knoerl R, Mazzola E, Woods H, Buchbinder E, Frazier L, LaCasce A, Luskin MR, Phillips CS, Thornton K, Berry DL, and Ligibel J
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- Child, Humans, Young Adult, Pandemics, Stress, Psychological therapy, Stress, Psychological psychology, Anxiety therapy, Anxiety psychology, Music Therapy methods, Mindfulness methods, COVID-19 therapy, Neoplasms complications, Neoplasms therapy, Neoplasms psychology
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The purpose of this secondary analysis was to explore physiological, psychological, and situational influencing factors that may affect the impact of a mindfulness-music therapy intervention on anxiety severity in young adults receiving cancer treatment. Young adults receiving cancer treatment for ≥ eight weeks were recruited from adult and pediatric oncology outpatient centers at Dana-Farber Cancer Institute. Participants were asked to attend up to four, in-person (offered virtually via Zoom video conference after the onset of the COVID-19 pandemic) 45-min mindfulness-based music therapy sessions over twelve weeks with a board-certified music therapist. Participants completed questionnaires about anxiety, stress, and other cancer treatment-related outcomes before and after participating in the intervention. Changes in anxiety (i.e., PROMIS Anxiety 4a) over time were compared among baseline physiological (e.g., age or sex), psychological (e.g., stress), and situational influencing (i.e., intervention delivery format) factors using Wilcoxon-rank sum tests. Thirty-one of the 37 enrolled participants completed the baseline and post-intervention measures and were eligible for inclusion in the secondary analysis. Results revealed that higher baseline physical functioning (median change = -6.65), anxiety (median change=-5.65), fatigue (median change = -5.6), sleep disturbance (median change = -5.6), female sex (median change = -5.15), or virtual intervention delivery (median change = -4.65) were potential physiological, psychological, or situational influencing factors associated with anxiety improvement following mindfulness-based music therapy. Additional investigation into physiological, psychological, or situational influencing factors associated with anxiety response will help to tailor the design of future mindfulness-music therapy interventions to decrease psychological distress and address the unique psychosocial concerns among young adults receiving cancer treatment. Trial Registration ClinicalTrials.gov Identifier: NCT03709225., (© The Author(s) 2023. Published by Oxford University Press on behalf of American Music Therapy Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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11. Translational and transdisciplinary research in energy balance and cancer: past is prologue.
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Irwin ML, Sears DD, and Ligibel J
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- Humans, Research Design, Energy Metabolism, Interdisciplinary Research, Neoplasms diagnosis, Neoplasms epidemiology, Neoplasms therapy
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- 2023
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12. Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy: Protocol for a Randomized Controlled Trial.
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Wilson R, Kang DW, Tahbaz M, Norris M, Uno H, Ligibel J, Guenette J, Christopher C, and Dieli-Conwright C
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Background: More than 75% of patients with breast cancer treated with chemotherapy experience cognitive impairments (eg, memory and attention problems), commonly known as chemo-brain. Exercise, especially aerobic high-intensity interval training (HIIT), is associated with better cognitive function in healthy populations. However, clinical trials testing the impact of exercise interventions on chemotherapy-induced cognitive decline in patients with cancer are lacking, and the mechanisms through which exercise could improve cognitive function are unclear., Objective: The objective of the Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy trial is to examine the effects of HIIT on cognitive function in patients with breast cancer undergoing chemotherapy., Methods: This 2-arm, single-center, pilot randomized controlled trial will randomize 50 patients with breast cancer undergoing chemotherapy to HIIT or attention control. The HIIT group will perform a supervised 16-week, thrice-weekly intervention, with each session including a 5-minute warm-up at 10% maximal power output (POmax), 10 sets of alternating 1-minute high-intensity (90% POmax) and 1-minute recovery (10% POmax) intervals, and a 5-minute cooldown (10% POmax). The attention control group will receive a stretching program with no exercise components and be asked to maintain their exercise levels for 16 weeks. The primary outcomes of the study are executive function and memory measured using the National Institutes of Health toolbox and resting-state connectivity and diffusion tensor imaging microstructure evaluated using magnetic resonance imaging. The secondary and tertiary outcomes include cardiorespiratory fitness, body composition, physical fitness, and psychosocial health. The study has been approved by the institutional review board of the Dana-Farber Cancer Institute (20-222)., Results: The trial was funded in January 2019, with recruitment started in June 2021. As of May 2022, a total of 4 patients have consented and been randomized (n=2, 50% to exercise; n=1, 25% to control; and n=1, 25% nonrandomized). Trial completion is expected in January 2024., Conclusions: This first-of-its-kind study incorporates a novel exercise intervention (ie, HIIT) and comprehensive cognitive measures. If positive, our findings will establish the pilot efficacy of HIIT on chemotherapy-induced cognitive function in patients with breast cancer, providing the foundation for future larger phase-II and phase-III trials to confirm the findings and potentially establish HIIT as a standard of care for women undergoing chemotherapy for breast cancer., Trial Registration: ClinicalTrials.gov NCT04724499; https://clinicaltrials.gov/ct2/show/NCT04724499., International Registered Report Identifier (irrid): DERR1-10.2196/39740., (©Rebekah Wilson, Dong-Woo Kang, Meghan Tahbaz, Mary Norris, Hajime Uno, Jennifer Ligibel, Jeffrey Guenette, Cameron Christopher, Christina Dieli-Conwright. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.04.2023.)
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- 2023
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13. Cancer Survivors' Perspectives of Virtual Yoga for Chronic Chemotherapy-Induced Peripheral Neuropathy Pain During the COVID-19 Pandemic.
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Knoerl R, Bockhoff J, Fox E, Giobbie-Hurder A, Berry DL, Berfield J, Meyerhardt J, Wright A, and Ligibel J
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- Humans, Pandemics, Antineoplastic Agents adverse effects, COVID-19, Cancer Survivors, Chronic Pain drug therapy, Neoplasms, Peripheral Nervous System Diseases chemically induced, Peripheral Nervous System Diseases therapy, Yoga
- Abstract
With the rise in telehealth due to the COVID-19 pandemic, further research is needed to determine how to optimize virtual delivery of existing integrative oncology interventions for cancer treatment-related symptoms. The purpose of this qualitative analysis was to explore cancer survivors' perspectives of the acceptability and satisfaction of an 8-week, virtual yoga intervention for cancer survivors with chronic chemotherapy-induced peripheral neuropathy pain. Fourteen participants with chronic chemotherapy-induced peripheral neuropathy pain who completed the virtual yoga intervention were interviewed using a semistructured interview guide. Themes were derived from the data using inductive content analysis methods. Main findings from the interviews included the following: (1) participants were willing to try new nonpharmacological treatments for chemotherapy-induced peripheral neuropathy due to the high symptom burden and prior lack of success with medications; (2) participants highly rated the flexibility offered by the virtual format, but desired the social support potentially offered by practicing in-person yoga; and (3) the impact of virtual yoga on chemotherapy-induced peripheral neuropathy severity was unclear. There were several barriers to participants' use of virtual yoga for chronic chemotherapy-induced peripheral neuropathy pain (eg, technology, lack of space/equipment). The results may be used to improve the design and delivery of future trials testing virtual yoga for chronic chemotherapy-induced peripheral neuropathy pain., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2022
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14. Self-Reported Severity, Characteristics, and Functional Limitations of Chemotherapy-Induced Peripheral Neuropathy.
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Knoerl R, Mazzola E, Hong F, Salehi E, McCleary N, Ligibel J, Reyes K, and Berry DL
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- Adolescent, Adult, Humans, Hypesthesia chemically induced, Hypesthesia drug therapy, Prospective Studies, Self Report, Young Adult, Antineoplastic Agents adverse effects, Peripheral Nervous System Diseases chemically induced
- Abstract
Background: The early identification of chemotherapy-induced peripheral neuropathy (CIPN) (e.g., numbness or tingling in the fingers or toes) is important due to its frequency and the few effective treatment options available. The identification of common patient-reported CIPN characteristics and associated functional limitations may help to facilitate patient-clinician discussions of CIPN in practice., Aims: To quantify the severity, duration, location, characteristics, and associated functional limitations of chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving neurotoxic chemotherapy., Design: Exploratory secondary analysis of a prospective, two-phase study SETTING: Breast, gastrointestinal, and multiple myeloma clinics at Dana-Farber Cancer Institute., Participants: 142 individuals who planned to receive at least three more cycles of neurotoxic chemotherapy after consent., Methods: Participants self-reported CIPN using standardized measures (i.e., PRO-CTCAE™ Numbness and Tingling Items or 0-10 numerical rating scale of worst CIPN pain intensity) and/or study team generated follow up questions about CIPN location, duration, characteristics, and functional limitations prior to three consecutive clinic visits (T1, T2, T3). Participants' responses to the CIPN self-report questionnaires were described by chemotherapy type and age., Results: Over approximately 36.5 days (T1-T3), the percentage of participants reporting at least mild CIPN increased from 59.3% to 71%. At T3, patients with non-painful (n = 98) or painful neuropathy (n = 34) frequently reported symptoms in the fingers (non-painful = 83.5%, painful = 76.5%) or toes (non-painful = 49.5%, painful = 41.2%) and characterized symptoms as numbness (non-painful = 54.1%, painful = 50%) or tingling (non-painful = 68.4%, painful = 82.4%). Self-reported CIPN functional limitations (n = 55) included difficulties with buttoning a shirt (38.2%) or walking (25.5%). Paclitaxel-related CIPN (n = 33) was frequently characterized as "continuous" (30.3%), whereas oxaliplatin-related CIPN (n = 51) was frequently characterized as "intermittent" (41.2%). Young adults (15-39 years old, n = 15) frequently reported moderate-severe non-painful CIPN (46.7%), painful CIPN (40%), and CIPN interference (33.3%)., Conclusions: Consistent with qualitative research, participants frequently described CIPN as numbness and/or tingling in the fingers and/or toes., Competing Interests: Declarations of Competing Interest None., (Copyright © 2021 Elsevier Ltd. All rights reserved.)
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- 2022
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15. Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial.
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Baedorf Kassis S, Lu W, White SA, Shin IH, Park SH, Jeong YJ, Yao C, Ligibel J, and Bierer BE
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- China, Humans, Republic of Korea, United States, Acupuncture Therapy
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Background: In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Given the study's approach, there was no central coordinating center or data monitoring committee for the study, so a site performance self-monitoring toolkit was developed and implemented to support study teams in collecting and maintaining high-quality regulatory information, and consistent review of study data and documentation., Methods: The site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality. The toolkit included: (1) a binder of essential study management documents and related monitoring logs for sites to complete and maintain (herein called regulator binder), (2) a study start-up checklist, (3) a self-assessment study conduct and oversight checklist to be completed regularly, and (4) a study close-out checklist. In addition, a process of regular virtual meetings to discuss documentation progress coupled with periodic external remote review of completed logs and checklists provided accountability checks., Results: Over the course of the study, the sites in China and South Korea completed the entirety of the site performance self-monitoring toolkit, and successfully submitted their completed materials for review. The process of implementing a self-monitoring toolkit in a multinational integrative medicine study is described qualitatively. Periodic external review of the completed toolkit materials revealed categories of findings. Written follow-up reports were provided to sites and discussion of the documents occurred via separate virtual meetings., Conclusions: Site study team self-monitoring provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities in higher risk studies. Iterative feedback and support appeared to drive a disciplined approach to maintaining regulatory document compliance and helped sustain investigator and study team engagement in the process., Trial Registration: ClinicalTrials.gov Identifier NCT03783546 (21/12/2018)., (© 2022. The Author(s).)
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- 2022
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16. Exploring Daily Salivary Cortisol Patterns as Biomarkers of Chronic Chemotherapy-Induced Peripheral Neuropathy Pain.
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Knoerl R, Giobbie-Hurder A, Berfield J, Berry D, Meyerhardt J, Wright A, and Ligibel J
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- Female, Humans, Biomarkers, Circadian Rhythm, Hydrocortisone, Hypothalamo-Hypophyseal System, Pain, Pituitary-Adrenal System, Saliva, Antineoplastic Agents, Peripheral Nervous System Diseases chemically induced
- Abstract
Objectives: Little is known about the biologic mechanisms of chronic chemotherapy-induced peripheral neuropathy (CIPN) pain. The purpose of this secondary analysis was to explore salivary cortisol patterns among cancer survivors with chronic CIPN pain to provide preliminary data regarding the role of hypothalamic-pituitary-adrenal axis dysregulation in the pathophysiology of this condition., Sample & Setting: 13 cancer survivors with chronic CIPN pain recruited from the breast, gastrointestinal, and gynecologic cancer centers at Dana-Farber Cancer Institute in Boston, Massachusetts., Methods & Variables: Salivary cortisol was collected on awakening, 30 minutes after awakening, and before going to bed on two consecutive days. Cortisol awakening response and diurnal cortisol slope were calculated by averaging results across two days., Results: Cortisol was available from 13 participants. The median cortisol awakening response was -0.03 mcg/dl, and the average diurnal cortisol slope was -0.24 mcg/dl., Implications for Nursing: Mechanism-based treatments are needed for cancer survivors with chronic CIPN pain. Nurse scientists may use study results to explore stress-related mechanisms of chronic CIPN pain.
- Published
- 2022
- Full Text
- View/download PDF
17. Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial.
- Author
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Sanft T, Harrigan M, Cartmel B, Ferrucci LM, Li FY, McGowan C, Zupa M, Nguyen TH, Ligibel J, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones B, Knobf T, Chagpar A, Silber A, and Irwin ML
- Subjects
- Exercise, Female, Humans, Life Style, Quality of Life, Randomized Controlled Trials as Topic, Breast Neoplasms drug therapy, Diet, Healthy
- Abstract
Background: The World Cancer Research Fund and the American Cancer Society provide nutrition and physical activity guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines and delay efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse treatment-related side effects and may improve adherence to treatment, resulting in improved breast cancer prognosis. The Lifestyle, Exercise, and Nutrition Early after Diagnosis (LEANer) study is testing the effect of a nutrition and physical activity intervention on chemotherapy completion rates., Methods: 172 women with stage I-III breast cancer undergoing chemotherapy will be randomized 1:1 to a yearlong, 16 session, nutrition and exercise intervention or usual care control group. The intervention is delivered by registered dietitians specializing in oncology nutrition and exercise training. The intervention includes goal setting to meet nutrition and physical activity guidelines for cancer survivors. After each chemotherapy session, date and dose of each drug administered, and reason for dose-adjustments and/or dose-delays are abstracted from the electronic medical record or obtained from the treating oncologist. Chemotherapy completion rate is assessed as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. Secondary endpoints of endocrine therapy adherence, treatment-related side effects, and changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes are assessed at four timepoints., Discussion: If successful, this study has the potential to make healthy lifestyle interventions a standard component of breast cancer treatment., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
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