Tara C Klinedinst, Zachary C Pope, Michael C Robertson, Nadia Stanley, Audrey Wint, Christina Henson, Darla E Kendzor
{"title":"数字介导的职业治疗增加城市和农村乳腺癌幸存者的身体活动:单组可行性试验方案。","authors":"Tara C Klinedinst, Zachary C Pope, Michael C Robertson, Nadia Stanley, Audrey Wint, Christina Henson, Darla E Kendzor","doi":"10.2196/73554","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06671730; https://clinicaltrials.gov/study/NCT06671730.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/73554.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73554"},"PeriodicalIF":1.5000,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12514410/pdf/","citationCount":"0","resultStr":"{\"title\":\"Digitally Mediated Occupational Therapy to Increase Physical Activity in Urban and Rural Breast Cancer Survivors: Protocol for a Single-Arm Feasibility Trial.\",\"authors\":\"Tara C Klinedinst, Zachary C Pope, Michael C Robertson, Nadia Stanley, Audrey Wint, Christina Henson, Darla E Kendzor\",\"doi\":\"10.2196/73554\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06671730; https://clinicaltrials.gov/study/NCT06671730.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/73554.</p>\",\"PeriodicalId\":14755,\"journal\":{\"name\":\"JMIR Research Protocols\",\"volume\":\"14 \",\"pages\":\"e73554\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2025-09-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12514410/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JMIR Research Protocols\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2196/73554\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JMIR Research Protocols","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2196/73554","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
Digitally Mediated Occupational Therapy to Increase Physical Activity in Urban and Rural Breast Cancer Survivors: Protocol for a Single-Arm Feasibility Trial.
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.