FITBIT Study on Mobility and Readmissions After Radical Cystectomy

NCT ID: NCT04314778

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2022-08-15

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

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day.

Group Type: EXPERIMENTAL

social incentive-based gamification

Intervention Type: BEHAVIORAL

At the beginning of each week, starting from postoperative day 3, the participant receives 70 points (10 points for each day that week). If the participant does not meet their daily step goal, they lose 10 points from their balance. This leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. At the end of each week if the participant has at least 40 points, they will move up a level (levels from lowest to highest: blue, bronze, silver, gold, platinum). If not, the participant will drop a level. All participants begin at the silver level. Each week, participants get a fresh set of 70 points. Participants will receive daily feedback for the step counts, and weekly feedback for their levels. Participants in the intervention arm will be asked to identify a family member or friend to be their support sponsor. A weekly report will be sent to this person with the participant's performance (points and level).

Control

Participants in the control group will have data collected passively via Fitbit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

social incentive-based gamification

At the beginning of each week, starting from postoperative day 3, the participant receives 70 points (10 points for each day that week). If the participant does not meet their daily step goal, they lose 10 points from their balance. This leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. At the end of each week if the participant has at least 40 points, they will move up a level (levels from lowest to highest: blue, bronze, silver, gold, platinum). If not, the participant will drop a level. All participants begin at the silver level. Each week, participants get a fresh set of 70 points. Participants will receive daily feedback for the step counts, and weekly feedback for their levels. Participants in the intervention arm will be asked to identify a family member or friend to be their support sponsor. A weekly report will be sent to this person with the participant's performance (points and level).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Daniel Lee, MD, MS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Abramson Cancer Center

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

833829

Identifier Type: -

Identifier Source: org_study_id