N/A
N=61
FITBIT Study on Mobility and Readmissions After Radical Cystectomy
Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04314778 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge — 1087; 995 mean change in daily steps
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- social incentive-based gamification (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge |
1087; 995 | — |
| SECONDARY Change in Mean Daily Step Count From the Postoperative Baseline to 3 Months After Discharge From the Hospital |
5674; 4660 | — |
Summary
This is a two-arm randomized, controlled trial during the postoperative period after major abdominal surgery for cancer, including for example radical cystectomy, nephrectomy, colectomy, comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- diagnosis of cancer undergoing definitive surgical treatment
Exclusion Criteria
- Inability to provide consent
- does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that the investigators can provide them
- any other medical conditions that would prohibit participation in a physical activity program
Data sourced from ClinicalTrials.gov (NCT04314778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.