The Feasibility of a Remote Maintenance Exercise Program for Cancer Survivors Supported by Health Coaching.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Feasibility of Exercise Class Attendance (Cohort 1)
研究概览
简要总结
The feasibility of an online maintenance exercise program for cancer survivors supported by health coaching.
详细描述
Purpose: The primary aim of this proposed mixed-methods study is to determine the feasibility of implementing a home-based exercise program with the support of telephone-based health coaching (HC). The secondary aim is to test the effectiveness of the program on physical activity (PA) levels, psychosocial well-being, and physical functioning.
Background: Cancer is the leading cause of death in Canada, and one in two Canadians will be diagnosed with cancer in their lifetime. Cancer treatments can prolong life, however it is often at the expense of a multitude of negative symptoms and side-effects that diminish quality of life (QOL). Exercise is one of the most effective and safe options among non-pharmaceutical interventions to manage the psychological and physiological side effects of cancer. Despite the known benefits, PA levels amongst cancer survivors are low. The main barriers to exercise in cancer survivors include lack of time, treatment-related side effects, and fatigue. One factor used to address these potential barriers is to have flexibility in programming, including varying sites for delivery of programs (centre vs home). While there is a preference towards home-based programs, adherence and maintenance rates are generally lower compared to group-based programs.
Rationale: Home-based programs can address the preferences of cancer survivors and potential barriers of exercise, such as access and lack of time. However, there is a need to increase adherence in a home-based program setting.
Objectives/ Research Question: The primary outcome measure of this pilot study is feasibility, while the secondary outcome measures include PA levels, physical functioning, and patient reported outcomes (PRO). We hypothesize that a home-based exercise program, designed to promote self-efficacy and supported by HC, will be maintained, and will improve physical activity levels, self-efficacy in managing the additional burden of isolation, and symptom management, such as chronic fatigue and QOL. The data collected will be used to inform the implementation of a home-based maintenance exercise program.
Research Plan: Assessments of the two intervention arms 1) online group maintenance classes (tapered sessions, 2x/wk for first 2 weeks; 1x/wk for remaining 6 weeks); and 2) online group maintenance classes (same tapered format) with HC (1x/week for approximately 30 minutes) will occur at baseline and post intervention. The first wave of the intervention was run from May until July 2020 for 8 weeks and the second wave was run from September until December 2020 for 12 weeks. Feasibility is the primary outcome measure, including recruitment rate (% who participate from those eligible), assessment completion, safety (adverse event reporting), attendance to remote maintenance classes, HC call completion, and attrition rates. Secondary outcomes include PROs of fatigue, loneliness, stress, social support, self-efficacy, QOL, and PA levels; and measures of physical functioning. Fatigue will be assessed using the FACIT-F. Social support will be assessed through the OSSS-3. Stress and loneliness will be assessed with the PSS and ULS-6 respectively. Self-efficacy will be assessed with a modified barrier SE scale and QOL with the FACT-general questionnaire. PA levels will be monitored objectively through weekly PA levels recorded with an accelerometer, and pre-/post intervention with the self-reported GLTEQ. Physical functioning assessments will be conducted remotely with a clinical exercise physiologist. Semi-structured interviews conducted post-intervention will focus on feasibility, including participant satisfaction, barrier management, pros/cons to the home-setting, value of the health coaching support, and facilitators to maintaining PA levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The certified exercise physiologists (CEP) instructing the exercise classes were unaware of the intervention each participant was assigned to. The CEP administering the physical functioning assessment was unaware of the participants intervention and was not the participants exercise class instructor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 years or older
- •Diagnosed with Cancer within the last 3 years
- •Passed Physical Activity Readiness Questionnaire + (PAR-Q+)
- •Completed at an ACE baseline class
- •Have access to a computer, laptop, iPad or Tablet with a video camera (with the Zoom app installed)
- •Have access to an internet connection strong enough to support a live video broadcast
排除标准
- •Active infections at the time of enrollment
- •Enteral tube feeding/parenteral nutrition
- •Mechanical or functional bowel obstruction due to any cause
- •Cognitive impairment
- •non-English speaking
- •Neuromusculoskeletal issues that impede participation
结局指标
主要结局
Feasibility of Exercise Class Attendance (Cohort 1)
时间窗: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
Percentage of class attendance by all participants was assessed and deemed feasible if attendance was equal or above 70%.
Feasibility of Exercise Class Attendance (Cohort 2)
时间窗: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
Percentage of class attendance by all participants was assessed and deemed feasible if attendance was equal or above 70%.
Feasibility of Recruitment
时间窗: Started about one month before study beginning and went until beginning of study (week 0)
Percentage of participants signing up for the study over the eligible cancer survivors will be calculated. 50% or higher recruitment rate will be deemed feasible.
Feasibility of Study completion (Cohort 1)
时间窗: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
The attrition rate of the study was calculated as the percentage of dropouts out of all participants.
Feasibility of Exercise Guidelines Adherence (Cohort 1)
时间窗: Beginning of exercise classes (week 1) until last week of exercise classes (end of week 8)
Percentage of participants meeting the exercise guidelines of 90 minutes of moderate to vigorous physical activity. 80% or higher adherence will be deemed feasible.
Feasibility of Exercise Guidelines Adherence (Cohort 2)
时间窗: Beginning of exercise classes (week 1) until last week of exercise classes (end of week 12)
Percentage of participants meeting the exercise guidelines of 90 minutes of moderate to vigorous physical activity. 80% or higher adherence will be deemed feasible.
Feasibility health coaching call completion (Cohort 1)
时间窗: Beginning of exercise classes (week 1) until last week of exercise classes (week 8)
Percentage of participants in the health coaching intervention completing all calls. 80% or higher completion will be deemed feasible.
Feasibility health coaching call completion (Cohort 2)
时间窗: Beginning of exercise classes (week 1) until last week of exercise classes (week 12)
Percentage of participants in the health coaching intervention completing all calls. 80% or higher completion will be deemed feasible.
Fidelity of the health coaching intervention (Cohort 1)
时间窗: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
The fidelity of the health coaching intervention will be reported based on how close the intervention followed the protocol. Two sessions of each participant were randomly recorded (through envelope draw). After study completion a research assistant will analyze the recording with the health coaching protocol checklist. The research assistant will report percent agreement with the protocol (9 items for each health coaching session) and the time spent on each part of the health coaching call.
Fidelity of the health coaching intervention (Cohort 2)
时间窗: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
The fidelity of the health coaching intervention will be reported based on how close the intervention followed the protocol. Two sessions of each participant were randomly recorded (through envelope draw). After study completion a research assistant will analyze the recording with the health coaching protocol checklist. The research assistant will report percent agreement with the protocol (9 items for each health coaching session) and the time spent on each part of the health coaching call.
Fidelity of the exercise intervention (Cohort 1)
时间窗: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
The fidelity of the exercise intervention will be reported based on how close the intervention followed the protocol. The research coordinator joined each exercise class, reported on the class and compared the class structure to the exercise protocol checklist (4 items for each exercise class (including: Alterations to pre-class, warm-up, exercise circuits, cool-down, and post-class conversation)). Percent agreement between protocol and intervention across all classes will be reported. Additionally, the amount of times participants showed up late and the amount of times technical difficulties arose (including audio/video and log in complications) will be reported.
Feasibility of Assessment Completion (Accelerometer) (Cohort 1)
时间窗: Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8
Percentage of days accelerometer was worn as intended was assessed and deemed feasible if completed wear time days were equal or above 70% of overall study days. The accelerometer wearing time was calculated as following: a day was counted if the accelerometer was worn for more than 10 hours, the percentage of days worn over the overall days of the study was calculated.
Fidelity of the exercise intervention (Cohort 2)
时间窗: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
The fidelity of the exercise intervention will be reported based on how close the intervention followed the protocol. The research coordinator joined each exercise class, reported on the class and compared the class structure to the exercise protocol checklist (4 items for each exercise class (including: Alterations to pre-class, warm-up, exercise circuits, cool-down, and post-class conversation)). Percent agreement between protocol and intervention across all classes will be reported. Additionally, the amount of times participants showed up late and the amount of times technical difficulties arose (including audio/video and log in complications) will be reported.
Semi-Structured Interview (Feasibility)
时间窗: Post-intervention (week 9 (first wave) or week 13 (second wave))
Include participant satisfaction, barrier management, pros/cons to the home-setting, value of the health coaching support, and facilitators to maintaining PA levels.
Feasibility of Study completion (Cohort 2)
时间窗: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
The attrition rate of the study was calculated as the percentage of dropouts out of all participants.
Feasibility of Assessment Completion (Questionnaire) (Cohort 1)
时间窗: Before study (week 0) and after study completion (Week 9)
Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 1)
时间窗: Before study (week 0) and after study completion (Week 9)
Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 2)
时间窗: Before study (week 0) and after study completion (Week 13)
Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completion (Questionnaire) (Cohort 2)
时间窗: Before study (week 0) and after study completion (Week 13)
Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completeness (Questionnaire) (Cohort 2)
时间窗: Before study (week 0) and after study completion (Week 13)
Percentage of all questions within the questionnaire answered by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completeness (Questionnaire) (Cohort 1)
时间窗: Before study (week 0) and after study completion (Week 9)
Percentage of all questions within the questionnaire answered by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completion (Accelerometer) (Cohort 2)
时间窗: Throughout the study from week 1 until end of week 12
Percentage of days accelerometer was worn as intended was assessed and deemed feasible if completed wear time days were equal or above 70% of overall study days. The accelerometer wearing time was calculated as following: a day was counted if the accelerometer was worn for more than 10 hours, the percentage of days worn over the overall days of the study was calculated.
次要结局
- Physical Activity Minutes Per Week (objective) (Cohort 2)(Throughout the study from week 1 until end of week 12)
- Physical Activity Minutes Per Week (subjective) (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Body Composition (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Body Composition (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Aerobic Endurance (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Strength Endurance (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Upper extremity flexibility (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Lower extremity flexibility (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Barrier Self-Efficacy (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Stress (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Physical Activity Minutes Per Week (objective) (Cohort 1)(Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8)
- Physical Activity Minutes Per Week (subjective) (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Aerobic Endurance (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Lower extremity flexibility (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Balance (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- General Wellbeing (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Strength Endurance (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Upper extremity flexibility (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Loneliness (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Balance (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Loneliness (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Barrier Self-Efficacy (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- General Wellbeing (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Fatigue (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Social Support (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Fatigue (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Social Support (Cohort 1)(Before study (week 0) and after study completion (Week 9))
- Stress (Cohort 2)(Before study (week 0) and after study completion (Week 13))
- Garmin Activity Tracker Usage (Cohort 2)(Post-intervention (week 13))