FITBIT Study on Mobility and Readmissions After Radical Cystectomy

NCT04314778 | Completed Results

• 1 other identifier: 833829
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge

  Change in mean daily step count

  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

Secondary Outcomes (1)

• 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

Other Outcomes (4)

• Rate of Placement to Skilled Nursing Facility After Hospital Discharge

  13 weeks after hospital discharge

• Rate of 90 Day Hospital Readmission After Hospital Discharge

  90 days after hospital discharge

• Rate of Postoperative Complications

  Immediately after the surgery to 3 months postoperatively

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: social incentive-based gamification

Control

NO INTERVENTION

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

Interventions

social incentive-based gamification 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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: S. Ryan Greysen, MD (Principal Investigator)
• Organization: University of Pennsylvania

Ryan.Greysen@pennmedicine.upenn.edu

215-614-0095

Study Officials

• Daniel Lee, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: March 19, 2020
• Study Start: November 15, 2019
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)