Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery

Bladder Cancer Clinical Trial

— FITBIT  

Official title:

Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314778
• Other study ID #: 833829
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: August 15, 2022

Study information

• Verified date: November 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Abramson Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of placement to skilled nursing facility after hospital discharge	Rate of placement to skilled nursing facility postoperatively	13 weeks after hospital discharge
Other	Rate of 90 day hospital readmission after hospital discharge	Rate of 90 day hospital readmission	90 days after hospital discharge
Other	Rate of postoperative complications	Rate of complications after the surgery	Immediately after the surgery to 3 months postoperatively
Other	Rate of postoperative delirium	Rate of delirium after the surgery	Immediately after the surgery to 3 months postoperatively
Primary	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.
Secondary	Change in mean daily step count from the postoperative baseline to 3 months after discharge from the hospital	Change in mean daily step count	From the postoperative baseline step count during 2 day run-in to 3 months after discharge from the hospital.