The EMPOWER Trial: Evaluating a Home-Based Physical Activity Program (PAP) With the ExerciseRx™ Digital Platform vs. Health Education Group (HEG) in People With Non-Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in mean daily step count
研究概览
简要总结
This clinical trial compares how well a home-based personalized physical activity program (PAP) that is delivered by a digital application (app) (the ExerciseRx app) works compared to health education in improving physical activity for patients with bladder cancer that has not reached the muscle wall of the bladder (non-muscle invasive). For people who are not physically active, previous studies have shown that increasing step counts can reduce incidence of death, reduce frailty, and reduce healthcare costs. The ExerciseRx app tracks adherence to home exercise, adapts step count goals based on the patient's progress, and provides encouraging feedback and motivation from the healthcare team. Additional features include activity summaries, progress towards current goal, nudges, helpful facts about the benefits of activity, and ideas for how to incorporate daily movement. A home-based PAP using the ExerciseRx app may work better in increasing physical activity among patients with non-muscle invasive bladder cancer compared to a health education only group.
详细描述
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (Health Education Group, HEG): Patients receive recommendations from their physicians and an educational pamphlet describing physical activity goals in line with National Comprehensive Cancer Network (NCCN) Survivorship for Healthy Living Guidelines. They receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen.
GROUP II (PAP INTERVENTION): Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive personalized daily step count goals that gradually increase over the study period. Patients also receive a FitBit® to wear continuously throughout the study, are given access to features of the ExerciseRx app (step count goals, home exercise videos), and receive an educational pamphlet as in Group I.
After completion of the study intervention, patients are followed up at 4 weeks.
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
- Single (Outcomes Assessor)
盲法说明
Study statistician will be blinded to group assignment
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
- •Adults (age >= 18 years)
- •Prior diagnosis of non-muscle invasive bladder cancer (NMIBC), currently on surveillance or receiving maintenance intravesical therapy (including intravesical chemotherapy, immunotherapy)
- •Classified as insufficiently active on the Physical Activity as a Vital Sign (PAVS) assessment
- •Has an Android or Apple Smartphone/Tablet
- •Ambulatory
- •English-speaking
- •Willing and able to participate in study activities and sign the informed consent form
排除标准
- •Severe cognitive or memory impairment/dementia precluding ability to follow instructions or participate in survey assessments
- •Inability to read or understand English
- •Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria to run the ExerciseRx app
- •Not receiving treatment at University of Washington (UW)
- •Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
- •Inability/Unwillingness to participate in a personalized exercise program
- •Current diagnosis with muscle-invasive or metastatic bladder cancer
- •Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using the ExerciseRx app
- •Participation in a clinical trial that does not permit enrollment in the EMPOWER trial
研究组 & 干预措施
Group II: Physical Activity Program (PAP) intervention
Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals. Patients also receive a FitBit® to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational pamphlet as in Group I.
干预措施: Exercise Intervention (Other)
Group I: Health Education Group (HEG)
Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational pamphlet describing physical activity goals in line with NCCN Survivorship for Healthy Living Guidelines.
干预措施: Questionnaire Administration (Other)
Group I: Health Education Group (HEG)
Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational pamphlet describing physical activity goals in line with NCCN Survivorship for Healthy Living Guidelines.
干预措施: Best Practice (Other)
Group I: Health Education Group (HEG)
Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational pamphlet describing physical activity goals in line with NCCN Survivorship for Healthy Living Guidelines.
干预措施: Internet-Based Intervention (Other)
Group I: Health Education Group (HEG)
Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational pamphlet describing physical activity goals in line with NCCN Survivorship for Healthy Living Guidelines.
干预措施: Health Telemonitoring (Other)
Group I: Health Education Group (HEG)
Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational pamphlet describing physical activity goals in line with NCCN Survivorship for Healthy Living Guidelines.
干预措施: Interview (Other)
Group I: Health Education Group (HEG)
Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational pamphlet describing physical activity goals in line with NCCN Survivorship for Healthy Living Guidelines.
干预措施: Electronic Health Record Review (Other)
Group I: Health Education Group (HEG)
Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational pamphlet describing physical activity goals in line with NCCN Survivorship for Healthy Living Guidelines.
干预措施: Educational Intervention (Other)
Group II: Physical Activity Program (PAP) intervention
Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals. Patients also receive a FitBit® to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational pamphlet as in Group I.
干预措施: Internet-Based Intervention (Other)
Group II: Physical Activity Program (PAP) intervention
Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals. Patients also receive a FitBit® to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational pamphlet as in Group I.
干预措施: Health Telemonitoring (Other)
Group II: Physical Activity Program (PAP) intervention
Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals. Patients also receive a FitBit® to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational pamphlet as in Group I.
干预措施: Educational Intervention (Other)
Group II: Physical Activity Program (PAP) intervention
Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals. Patients also receive a FitBit® to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational pamphlet as in Group I.
干预措施: Questionnaire Administration (Other)
Group II: Physical Activity Program (PAP) intervention
Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals. Patients also receive a FitBit® to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational pamphlet as in Group I.
干预措施: Interview (Other)
Group II: Physical Activity Program (PAP) intervention
Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals. Patients also receive a FitBit® to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational pamphlet as in Group I.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Change in mean daily step count
时间窗: Baseline (1 week prior to trial initiation) and timepoint 2 (12 weeks)
Average daily step count (per 24-hour day) will be assessed by the Fitbit tracker. Summary statistics (mean and standard deviations; counts and percentages) will be used to describe and compare baseline characteristics between the two treatment arms. Will use a linear mixed effects model with average daily step count as the outcome, with fixed effects for time (T1, T2, and T3), treatment assignment, and the week-treatment interaction, and a random intercept for each participant. A significant interaction between T2 and treatment assignment will indicate the change in step count from baseline to T2 differs between the two treatment arms and will be used to evaluate the co-primary outcomes of step-count improvement at the end of treatment using a two-sided significance level of 0.05. The minimum amount of time that participants need to have worn the Fitbit for their step data to be valid for use in analysis is one week (7 days) post baseline period.
Qualitative experience
时间窗: Week 16
Will be assessed by Zoom interviews (usability interview) with a subset of volunteer participants from the physical activity program (PAP) arm. Will analyze the semi-structured interview data using a process of reflexive thematic analysis, drawing on our reflexivity as designers, health informatics researchers, and clinical researchers to interpret data and construct themes using affinity analysis to identify ways in which ExerciseRx can be improved to meet the needs of patients with bladder cancer. Similarly, will apply the Discover Design Built Test framework from the University of Washington ALACRITY Center to adapt the ExerciseRx provider dashboard for healthcare providers caring for patients with bladder cancer.
次要结局
- Active time/24 hours (minutes) per week on study(Up to 12 weeks)
- Change in mean daily step count(Baseline up to 4 weeks post intervention)
- Change in functional mobility(Baseline up to 4 weeks post intervention)
- Change in frailty(Baseline up to 4 weeks post intervention)
- Change in health-related quality of life(Baseline up to 4 weeks post intervention)
- Change in fatigue(Baseline up to 4 weeks post intervention)
- Change in pain(Baseline up to 4 weeks post intervention)
- Change in anxiety/depression(Baseline up to 4 weeks post intervention)
- Change in distress(Baseline up to 4 weeks post intervention)
- Change in resiliency(Baseline up to 4 weeks post intervention)
- Change in treatment burden(Baseline up to 4 weeks post intervention)
- Incidence of patient-reported musculoskeletal adverse events(Baseline up to 4 weeks post intervention)
- Incidence of treatment-associated toxicity(Baseline up to 4 weeks post intervention)
- Incidence of patient-reported outcomes(Up to 4 weeks post intervention)
- Barriers and facilitators to exercise(Baseline up to 4 weeks post intervention)
- Change in Lifespace(Baseline up to 4 weeks post intervention)