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

Study Overview
=================
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.

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

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Behavioral: social incentive-based gamification


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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).<br>|
| No Intervention: Control<br>Participants in the control group will have data collected passively via Fitbit. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |