Nadia Stanley

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: The 5-year survival rate for breast cancer (BC) has increased in recent years. However, functional limitations associated with BC treatment (eg, loss of strength, fatigue, and lymphedema) often have far-reaching effects on survivors’ physical and mental health. Aerobic physical activity (PA) and muscle-strengthening exercise (MSE) can reduce functional limitations, and occupational therapy (OT) can support these health-promoting behaviors after treatment. Yet, barriers to access among BC survivors (eg, time burden and distance to the OT clinic) limit participation in OT programing. This is particularly true in Oklahoma, where 33% of residents live in rural counties. Digital technologies (eg, telehealth) can help urban and rural BC survivors circumvent these barriers. Objective: We are investigating the feasibility of a novel OT program among urban and rural BC survivors that features (1) 8 once-weekly telehealth OT sessions targeting constructs grounded in Self-Determination Theory (SDT), and (2) self-regulatory strategies known to support aerobic PA and MSE in BC survivors including self-monitoring via a wearable PA tracker, goal setting, and the provision of timely feedback. Methods: This is a single-arm feasibility trial. We are recruiting 38 BC survivors using community-based recruitment approaches and via referral from collaborating oncologists. Participants include individuals who have undergone primary treatment and/or breast-conserving surgery or mastectomy for BC in the last 24 months and who do not meet recommended PA levels at the time of enrollment. We will assess self-reported program acceptability and feasibility via recruitment rates, study retention, and protocol adherence. We will also evaluate program safety by tracking BC-related lymphedema events, musculoskeletal injuries, and other adverse events. Finally, we will assess changes in aerobic PA, MSE, and health-related quality of life during the program period using accelerometry and self-report measurement tools. Results: We received funding in March 2024 and institutional review board approval in September 2024. We began recruiting in November 2024. We anticipate completing data collection in early 2026. We hypothesize that the SDT-grounded OT program will be acceptable, feasible, and safe. We also expect pre- to post-program improvements in (1) SDT-informed determinants of PA, (2) levels of aerobic PA and MSE engagement, and (3) health-related quality of life. Conclusions: The novel OT program under investigation is designed to decrease barriers to engaging in aerobic PA and MSE among people who have undergone various BC treatments. It is centered on facilitating a successful transition from active treatment to the posttreatment period and combines OT with the benefits of telehealth delivery and health behavior change theory. This program is amenable to wide-scale dissemination and, if shown to be acceptable and feasible, will represent a promising approach to supportive cancer care. Trial Registration: ClinicalTrials.gov NCT06671730; https://clinicaltrials.gov/study/NCT06671730

BACKGROUND The 5-year survival rate for breast cancer (BC) has increased in recent years. However, functional limitations associated with BC treatment (eg, loss of strength, fatigue, and lymphedema) often have far-reaching effects on survivors’ physical and mental health. Aerobic physical activity (PA) and muscle-strengthening exercise (MSE) can reduce functional limitations, and occupational therapy (OT) can support these health-promoting behaviors after treatment. Yet, barriers to access among BC survivors (eg, time burden and distance to the OT clinic) limit participation in OT programing. This is particularly true in Oklahoma, where 33% of residents live in rural counties. Digital technologies (eg, telehealth) can help urban and rural BC survivors circumvent these barriers. OBJECTIVE We are investigating the feasibility of a novel OT program among urban and rural BC survivors that features (1) 8 once-weekly telehealth OT sessions targeting constructs grounded in Self-Determination Theory (SDT), and (2) self-regulatory strategies known to support aerobic PA and MSE in BC survivors including self-monitoring via a wearable PA tracker, goal setting, and the provision of timely feedback. METHODS This is a single-arm feasibility trial. We are recruiting 38 BC survivors using community-based recruitment approaches and via referral from collaborating oncologists. Participants include individuals who have undergone primary treatment and/or breast-conserving surgery or mastectomy for BC in the last 24 months and who do not meet recommended PA levels at the time of enrollment. We will assess self-reported program acceptability and feasibility via recruitment rates, study retention, and protocol adherence. We will also evaluate program safety by tracking BC-related lymphedema events, musculoskeletal injuries, and other adverse events. Finally, we will assess changes in aerobic PA, MSE, and health-related quality of life during the program period using accelerometry and self-report measurement tools. RESULTS We received funding in March 2024 and institutional review board approval in September 2024. We began recruiting in November 2024. We anticipate completing data collection in early 2026. We hypothesize that the SDT-grounded OT program will be acceptable, feasible, and safe. We also expect pre- to post-program improvements in (1) SDT-informed determinants of PA, (2) levels of aerobic PA and MSE engagement, and (3) health-related quality of life. CONCLUSIONS The novel OT program under investigation is designed to decrease barriers to engaging in aerobic PA and MSE among people who have undergone various BC treatments. It is centered on facilitating a successful transition from active treatment to the posttreatment period and combines OT with the benefits of telehealth delivery and health behavior change theory. This program is amenable to wide-scale dissemination and, if shown to be acceptable and feasible, will represent a promising approach to supportive cancer care. CLINICALTRIAL ClinicalTrials.gov NCT06671730; https://clinicaltrials.gov/study/NCT06671730 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/73554