FITBIT Study on Mobility and Readmissions After Radical Cystectomy

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Behavioral: social incentive-based gamification

• Registration Number: NCT04314778
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

We will conduct a two-arm randomized, controlled trial during the postoperative period after a radical cystectomy for bladder cancer, 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. Patients will be enrolled after being diagnosed with bladder cancer and scheduled to undergo a radical cystectomy. The median length of stay after a radical cystectomy is 8 days, with 90% being discharged within two weeks. Postoperatively, the baseline step count will be averaged by taking the steps taken during the first two days outside of the intensive care unit. There will be two postoperative phases: Phase I will be while the patient is hospitalized postoperatively. Phase II will be when the patient is discharged for three months.

5.2 Study

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-15
• Results First Submitted: 2024-07-14
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Results First Posted: 2024-12-24
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age 18 years or older
• diagnosis of cancer undergoing definitive surgical treatment

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	social incentive-based gamification	Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day.

Primary Outcome Measures

Name	Time	Method
Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge	From baseline step count after a two-day run-in period after the surgery to the time of hospital discharge postoperatively. As the time to discharge was variable, this time period was up to 60 days after surgery	Change in mean daily step count

Secondary Outcome Measures

Name	Time	Method
Change in Mean Daily Step Count From the Postoperative Baseline to 3 Months After Discharge From the Hospital	From the postoperative baseline step count during 2 day run-in to 3 months after discharge from the hospital. This time was up to 3 months after discharge	Change in mean daily step count

Trial Locations

Locations (2)

Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States