Localized Non-Muscle Invasive Bladder Urothelial CarcinomaEMPOWERNCT07302230
Home-Based Physical Activity Program With Digital App Versus Health Education Group for Improving Physical Activity Among Patients With Non-muscle Invasive Bladder Cancer, The EMPOWER Trial
A study testing Internet-Based Intervention, Best Practice and Exercise Intervention in people with Localized Non-Muscle Invasive Bladder Urothelial Carcinoma and Stage 0a Bladder Cancer AJCC v8, run by University of Washington at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Localized Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8
- What is being tested?
- Internet-Based Intervention, Best Practice and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to 27 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Sarah Psutka, MD, MSc, 206-210-4040, spsutka@uw.edu
Sarah Psutka, MD, MSc
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Localized Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Being tested
- Internet-Based Intervention, Best Practice, Exercise Intervention, Health Telemonitoring, Educational Intervention
- Keywords
- Urinary Bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Given access to the ExerciseRx app
Best PracticeOther
Also called standard of care
Given instruction to continue physical activity as usual
Internet-Based InterventionOther
Given access to the ExerciseRx app locked to the baseline home screen
Exercise InterventionOther
Complete home exercise sessions
Health TelemonitoringOther
Given a FitBit® to wear continuously
Educational InterventionOther
Given NCCN Survivorship for Healthy Living Guidelines pamphlet
Questionnaire AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
Electronic Health Record ReviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Best Practice; Other: Internet-Based Intervention; Other: Health Telemonitoring; Other: Educational Intervention; Other: Questionnaire Administration; Other: Interview; Other: Electronic Health Record Review |
| 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. Receives: Other: Internet-Based Intervention; Other: Exercise Intervention; Other: Health Telemonitoring; Other: Educational Intervention; Other: Questionnaire Administration; Other: Interview; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 16
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start11 Mar 2026
- Primary completion23 Aug 2027 (estimated)
- Study completion27 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Non-Muscle Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Andy Hill CARE Fund
- Responsible party
- Sponsor
- Investigators
- Sarah Psutka, MD, MSc, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302230
- Sponsor's protocol ID
- RG1125987
- Other IDs
- NCI-2025-08850, 21052
- Acronym
- EMPOWER
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07302230
- Acronym / sponsor ID
- EMPOWER / RG1125987
- Conditions
- Localized Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Keywords
- Urinary Bladder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Andy Hill CARE Fund
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 23 Aug 2027 (estimated)
- Study completion
- 27 Sep 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Health Education Group (HEG) | Active comparator | Other: Best Practice, Other: Internet-Based Intervention, Other: Health Telemonitoring, Other: Educational Intervention, Other: Questionnaire Administration, Other: Interview, Other: Electronic Health Record ReviewPatients 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. |
| Group II: Physical Activity Program (PAP) intervention | Experimental | Other: Internet-Based Intervention, Other: Exercise Intervention, Other: Health Telemonitoring, Other: Educational Intervention, Other: Questionnaire Administration, Other: Interview, Other: Electronic Health Record ReviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionGiven access to the ExerciseRx app | Other | Group II: Physical Activity Program (PAP) intervention |
| Best PracticeAlso: standard of careGiven instruction to continue physical activity as usual | Other | Group I: Health Education Group (HEG) |
| Internet-Based InterventionGiven access to the ExerciseRx app locked to the baseline home screen | Other | Group I: Health Education Group (HEG) |
| Exercise InterventionComplete home exercise sessions | Other | Group II: Physical Activity Program (PAP) intervention |
| Health TelemonitoringGiven a FitBit® to wear continuously | Other | Group I: Health Education Group (HEG), Group II: Physical Activity Program (PAP) intervention |
| Educational InterventionGiven NCCN Survivorship for Healthy Living Guidelines pamphlet | Other | Group I: Health Education Group (HEG), Group II: Physical Activity Program (PAP) intervention |
| Questionnaire AdministrationAncillary studies | Other | Group I: Health Education Group (HEG), Group II: Physical Activity Program (PAP) intervention |
| InterviewAncillary studies | Other | Group I: Health Education Group (HEG), Group II: Physical Activity Program (PAP) intervention |
| Electronic Health Record ReviewAncillary studies | Other | Group I: Health Education Group (HEG), Group II: Physical Activity Program (PAP) intervention |
Primary outcome
Change in mean daily step count
Time frame: 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
Time frame: 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.
16 secondary outcomes
Active time/24 hours (minutes) per week on study
Time frame: Up to 12 weeks
Change in mean daily step count
Time frame: Baseline up to 4 weeks post intervention
Change in functional mobility
Time frame: Baseline up to 4 weeks post intervention
Change in frailty
Time frame: Baseline up to 4 weeks post intervention
Change in health-related quality of life
Time frame: Baseline up to 4 weeks post intervention
Change in fatigue
Time frame: Baseline up to 4 weeks post intervention
Change in pain
Time frame: Baseline up to 4 weeks post intervention
Change in anxiety/depression
Time frame: Baseline up to 4 weeks post intervention
Change in distress
Time frame: Baseline up to 4 weeks post intervention
Change in resiliency
Time frame: Baseline up to 4 weeks post intervention
Change in treatment burden
Time frame: Baseline up to 4 weeks post intervention
Incidence of patient-reported musculoskeletal adverse events
Time frame: Baseline up to 4 weeks post intervention
Incidence of treatment-associated toxicity
Time frame: Baseline up to 4 weeks post intervention
Incidence of patient-reported outcomes
Time frame: Up to 4 weeks post intervention
Barriers and facilitators to exercise
Time frame: Baseline up to 4 weeks post intervention
Change in Lifespace
Time frame: Baseline up to 4 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Psutka, MD, MSc principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Best Practice and Exercise Intervention in people with Localized Non-Muscle Invasive Bladder Urothelial Carcinoma and Stage 0a Bladder Cancer AJCC v8, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Psutka, MD, MSc (206-210-4040, spsutka@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean daily step count (time frame: Baseline (1 week prior to trial initiation) and timepoint 2 (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.