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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-08850 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 21052 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| Andy Hill CARE Fund | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: Health Education Group (HEG) | Active Comparator | 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. |
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| Group II: Physical Activity Program (PAP) intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Given access to the ExerciseRx app |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in mean daily step count | 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. | Baseline (1 week prior to trial initiation) and timepoint 2 (12 weeks) |
| Qualitative experience | 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Active time/24 hours (minutes) per week on study | A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to Health Education Group (HEG). Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Psutka, MD, MSc | Contact | 206-210-4040 | spsutka@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Psutka, MD, MSc | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
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Study statistician will be blinded to group assignment
| Best Practice | Other | Given instruction to continue physical activity as usual |
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| Internet-Based Intervention | Other | Given access to the ExerciseRx app locked to the baseline home screen |
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| Exercise Intervention | Other | Complete home exercise sessions |
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| Health Telemonitoring | Other | Given a FitBit® to wear continuously |
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| Educational Intervention | Other | Given NCCN Survivorship for Healthy Living Guidelines pamphlet |
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| Questionnaire Administration | Other | Ancillary studies |
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| Interview | Other | Ancillary studies |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Up to 12 weeks |
| Change in mean daily step count | A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in functional mobility | Assessed by the Short Physical Performance Battery. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in frailty | Assessed by the Cancer and Aging Research Group - Geriatric Assessment. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in health-related quality of life | Will include physical function, role function, emotional function, cognitive function, and social function. Assessed by the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (Core 30) (EORTC-QLQ-C30) and EORTC Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer Module (24 items) (EORTC-QLQ-NMIBC24). A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in fatigue | Will be assessed using the Insomnia and Symptom Scale of the EORTC-QLQ-C30. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in pain | Will be assessed using the Symptom Scale of the EORTC-QLQ-C30. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in anxiety/depression | Will be assessed using the Hospital Anxiety and Depression Scale (HADS)-Anxiety and HADS-Depression (14 items). A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in distress | Will be assessed using the Perceived Stress Scale. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in resiliency | Will be assessed using the Brief Resiliency Scale. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in treatment burden | Will be assessed using the Treatment Burden Questionnaire (engagement in healthcare). Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Incidence of patient-reported musculoskeletal adverse events | A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Incidence of treatment-associated toxicity | Will be assessed using the EORTC-NMIBC 24. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Incidence of patient-reported outcomes | Will be assessed using the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events version 5.0 and chart review. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Up to 4 weeks post intervention |
| Barriers and facilitators to exercise | Will be assessed using the weekly barriers and facilitators to exercise survey. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| Change in Lifespace | Will be assessed using the Lifespace questionnaire. A linear mixed effect model will be used to analyze the impact of the ExerciseRx platform comparing PAP to HEG. Each model will include this outcome with fixed effects for time, treatment assignment, and the time-treatment interaction as well as a random effect for each participant to account for repeated measures. Significant interaction terms will indicate a treatment effect is present at that measurement time. | Baseline up to 4 weeks post intervention |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D018479 | Early Intervention, Educational |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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