Browsing by Author "Culos-Reed, S. N."
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Item Open Access Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial(2021-10-14) Smith-Turchyn, Jenna; McCowan, Michelle E.; O’Loughlin, Erin; Fong, Angela J.; McDonough, Meghan H.; Santa Mina, Daniel; Arbour-Nicitopoulos, Kelly P.; Trinh, Linda; Jones, Jennifer M.; Bender, Jackie L.; Culos-Reed, S. N.; Tomasone, Jennifer R.; Vani, Madison F.; Sabiston, Catherine M.Abstract Background Peer-based exercise interventions that cultivate new opportunities for support with a fellow cancer survivor may result in increased exercise volume. It is not clear whether adding qualified exercise professional (QEP) support to peer-based interventions improves health outcomes. Therefore, the purpose of this study is to determine whether breast cancer survivor (BCS) dyads who receive 10 weekly sessions of virtually delivered QEP support have improved outcomes compared to BCS dyads who do not receive QEP support. Methods Participants Adult BCS with medical clearance for exercise, who have an internet-connected device, and currently engage in < 150 min of moderate-intensity exercise per week. Intervention BCS will be matched using evidence-based criteria. The intervention group will receive dyadic exercise information sessions and a program tailored by a QEP for 10 weeks (intervention period) and have access to the QEP for an additional 4 weeks (tapering period). The control will not receive any QEP support. Outcomes The primary outcome is post-intervention self-reported exercise volume. Secondary outcomes include device-assessed exercise volume (i.e., Fitbit), social support, and health-related quality of life. Randomization 108 participants, matched in dyads, will be randomized 1:1 to the MatchQEP or Match groups using a web-based scheme. Statistical analysis Outcomes will be measured at baseline, post-intervention, post-tapering, and at 12 weeks post-intervention follow-up. Discussion The findings from this RCT will determine if matched BCS dyads who receive 10 weeks of virtually delivered QEP support have higher levels of self-report and device-measured exercise, social support, and health related quality of life compared to matched dyads without QEP-delivered exercise guidance. To our knowledge this will be the first study to assess the combined effect of peer- and QEP support on exercise volume. Project findings will inform and optimize intervention methods aimed to increase exercise among BCS through accessible exercise supports. Trial Registration: The study is registered on ClinicalTrials.gov (study identifier: NCT04771975, protocol Version Number: 2, date: July 22, 2021).Item Open Access Effects of a support group leader education program jointly developed by health professionals and patients on peer leader self-efficacy among leaders of scleroderma support groups: a two-arm parallel partially nested randomised controlled trial(2022-10-28) Thombs, Brett D.; Levis, Brooke; Carrier, Marie-Eve; Dyas, Laura; Nordlund, Julia; Tao, Lydia; Aguila, Kylene; Bourgeault, Angelica; Konrad, Violet; Sauvé, Maureen; Connolly, Kerri; Henry, Richard S.; Østbø, Nora; Levis, Alexander W.; Kwakkenbos, Linda; Malcarne, Vanessa L.; El-Baalbaki, Ghassan; Hudson, Marie; Wurz, Amanda; Culos-Reed, S. N.; Platt, Robert W.; Benedetti, AndreaAbstract Background More people with rare diseases likely receive disease education and emotional and practical support from peer-led support groups than any other way. Most rare-disease support groups are delivered outside of the health care system by untrained leaders. Potential benefits may not be achieved and harms, such as dissemination of inaccurate information, may occur. Our primary objective was to evaluate the effects of a rare-disease support group leader education program, which was developed collaboratively by researchers, peer support group leaders, and patient organization leaders, compared to waitlist control, on peer leader self-efficacy among scleroderma support group leaders. Methods The trial was a pragmatic, two-arm partially nested randomised controlled trial with 1:1 allocation into intervention or waitlist control. Eligible participants were existing or candidate peer support group leaders affiliated with a scleroderma patient organization. Leader training was delivered in groups of 5–6 participants weekly for 13 weeks in 60–90 min sessions via the GoToMeeting® videoconferencing platform. The program included 12 general leader training modules and one module specific to scleroderma. Primary outcome was leader self-efficacy, measured by the Support Group Leader Self-efficacy Scale (SGLSS) immediately post-intervention. Secondary outcomes were leader self-efficacy 3 months post-intervention; emotional distress, leader burnout, and volunteer satisfaction post-intervention and 3 months post-intervention; and program satisfaction among intervention participants post-intervention. Results One hundred forty-eight participants were randomised to intervention (N = 74) or waitlist (N = 74). Primary outcome data were provided by 146 (99%) participants. Mean number of sessions attended was 11.4 (standard deviation = 2.6). Mean program satisfaction score (CSQ-8) was 30.3 (standard deviation = 3.0; possible range 8–32). Compared to waitlist control, leader self-efficacy was higher post-intervention [SGLSS; 16.7 points, 95% CI 11.0–22.3; standardized mean difference (SMD) 0.84] and 3 months later (15.6 points, 95% CI 10.2–21.0; SMD 0.73); leader volunteer satisfaction was significantly higher at both assessments, emotional distress was lower post-intervention but not 3 months later, and leader burnout was not significantly different at either assessment. Conclusions Peer support group leader education improved leader self-efficacy substantially. The program could be easily adapted for support group leaders in other rare diseases. Trial registration: NCT03965780 ; registered on May 29, 2019.Item Open Access Exploring feasibility, perceptions of acceptability, and potential benefits of an 8-week yoga intervention delivered by videoconference for young adults affected by cancer: a single-arm hybrid effectiveness-implementation pilot study(2023-03-10) Wurz, Amanda; McLaughlin, Emma; Hughes, Kimberly; Ellis, Kelsey; Chen, Amy; Cowley, Lauren; Molina, Heather; Duchek, Delaney; Eisele, Maximilian; Culos-Reed, S. N.Abstract Background Young adults affected by cancer face physical and psychological challenges and desire online supportive care. Yoga can be delivered online and may improve physical and psychological outcomes. Yet, yoga has rarely been studied with young adults affected by cancer. To address this, an 8-week yoga intervention was developed, and a pilot study was deemed necessary to explore feasibility, acceptability, implementation, and potential benefits. Methods A mixed-methods, single-arm hybrid effectiveness-implementation pilot study evaluating the yoga intervention was conducted. Feasibility was assessed by tracking enrollment, retention, attendance, completeness of data, and adverse events. Acceptability was explored through interviews. Implementation metrics included training time, delivery resources, and fidelity. Potential effectiveness was evaluated by exploring changes in physical (i.e., balance, flexibility, range of motion, functional mobility) and psychological (i.e., quality of life, fatigue, resilience, posttraumatic growth, body image, mindfulness, perceived stress) outcomes at pre- (week 0), post- (week 8), and follow-up (week 16) time points. Data were analyzed with descriptive statistics, repeated measures analysis of variance, and content analysis. Results Thirty young adults participated in this study (recruitment rate = 33%). Retention to study procedures was 70%, and attendance ranged from 38 to 100%. There were little missing data (< 5%) and no adverse events. Though most participants were satisfied with the yoga intervention, recommendations for improvement were shared. Sixty study-specific training hours and > 240 delivery and assessment hours were accrued and fidelity was high. Functional mobility, flexibility, quality of life (energy/fatigue, social well-being), body image (appearance evaluation), mindfulness (non-reactivity), and perceived stress improved significantly over time (all p< 0.050; $$\eta_{p}{}^{2}s=0.124-0.292$$ η p 2 s = 0.124 - 0.292 ). No other significant changes were observed (all p> 0.050; $$\eta_{p}{}^{2}s=0.005-0.115$$ η p 2 s = 0.005 - 0.115 ). Conclusions The yoga intervention may confer physical and psychological benefits, though intervention and study-specific modifications are required to improve feasibility and acceptability. Requiring study participation and providing greater scheduling flexibility could enhance recruitment and retention. Increasing the frequency of classes offered each week and offering more opportunities for participant interaction could improve satisfaction. This study highlights the value of doing pilot work and provides data that has directly informed intervention and study modifications. Findings could also be used by others offering yoga or supportive care by videoconference to young adults affected by cancer. Trial registration Not available—not registeredItem Open Access The feasibility of patient-reported outcomes, physical function, and mobilization in the care pathway for head and neck cancer surgical patients(2022-05-27) Daun, Julia T.; Twomey, Rosie; Capozzi, Lauren C.; Crump, Trafford; Francis, George J.; Matthews, T. W.; Chandarana, Shamir; Hart, Robert D.; Schrag, Christiaan; Matthews, Jennifer; McKenzie, C. D.; Lau, Harold; Dort, Joseph C.; Culos-Reed, S. N.Abstract Background Head and neck cancer (HNC) patients are an understudied population whose treatment often includes surgery, causing a wide range of side effects. Exercise prehabilitation is a promising tool to optimize patient outcomes and may confer additional benefits as a prehabilitation tool. The primary objective of this study was to assess the feasibility of measuring patient-reported outcomes (PROs), physical function, and in-hospital mobilization across the HNC surgical timeline in advance of a future prehabilitation trial. The secondary objective was to examine potential changes in these outcomes across the surgical timeline. Methods HNC patients scheduled to undergo oncologic resection with free-flap reconstruction completed assessments of PROs and physical function at three timepoints across the surgical timeline (baseline, in-hospital, and postsurgical/outpatient). Mobilization was measured during the in-hospital period. The feasibility of recruitment and measurement completion was tracked, as were changes in both PROs and physical function. Results Of 48 eligible patients, 16 enrolled (recruitment rate of 33%). The baseline and in-hospital PROs were completed by 88% of participants, while the outpatient assessments were completed by 81% of participants. The baseline and in-hospital assessment of physical function were completed by 56% of participants, and 38% completed the outpatient assessment. Measuring in-hospital mobilization was completed for 63% of participants. Conclusion Measuring PROs and in-hospital mobilization is feasible across the surgical timeline in HNC; however, the in-person assessment of physical function prior to surgery was not feasible. A multidisciplinary collaboration between exercise specialists and clinicians supported the development of new clinical workflows in HNC surgical care that will aid in the implementation of a future prehabilitation trial for this patient population.Item Open Access The online delivery of exercise oncology classes supported with health coaching: a parallel pilot randomized controlled trial(2023-05-12) Eisele, Maximilian; Pohl, Andrew J.; McDonough, Meghan H.; McNeely, Margaret L.; Ester, Manuel; Daun, Julia T.; Twomey, Rosie; Culos-Reed, S. N.Abstract Purpose The primary objective was to investigate the feasibility of a synchronous, online-delivered, group-based, supervised, exercise oncology maintenance program supported with health coaching. Methods Participants had previously completed a 12-week group-based exercise program. All participants received synchronous online delivered exercise maintenance classes, and half were block randomized to receive additional weekly health coaching calls. A class attendance rate of ≥ 70%, a health coaching completion rate of ≥ 80%, and an assessment completion rate of ≥ 70% were set as markers of feasibility. Additionally, recruitment rate, safety, and fidelity of the classes and health coaching calls were reported. Post-intervention interviews were performed to further understand the quantitative feasibility data. Two waves were conducted — as a result of initial COVID-19 delays, the first wave was 8 weeks long, and the second wave was 12 weeks long, as intended. Results Forty participants (n8WK = 25; n12WK = 15) enrolled in the study with 19 randomized to the health coaching group and 21 to the exercise only group. The recruitment rate (42.6%), attrition (2.5%), safety (no adverse events), and feasibility were confirmed for health coaching attendance (97%), health coaching fidelity (96.7%), class attendance (91.2%), class fidelity (92.6%), and assessment completion (questionnaire = 98.8%; physical functioning = 97.5%; Garmin wear-time = 83.4%). Interviews highlighted that convenience contributed to participant attendance, while the diminished ability to connect with other participants was voiced as a drawback compared to in-person delivery. Conclusion The synchronous online delivery and assessment of an exercise oncology maintenance class with health coaching support was feasible for individuals living with and beyond cancer. Providing feasible, safe, and effective exercise online to individuals living with cancer may support increased accessibility. For example, online may provide an accessible alternative for those living in rural/remote locations as well as for those who may be immunocompromised and cannot attend in-person classes. Health coaching may additionally support individuals’ behavior change to a healthier lifestyle. Trial registration The trial was retrospectively registered (NCT04751305) due to the rapidly evolving COVID-19 situation that precipitated the rapid switch to online programming.