Clinical trial NCT04314778: FITBIT Study on Mobility and Readmissions After Radical Cystectomy
Official title: Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge
timeFrame: 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:
measure: Change in Mean Daily Step Count From the Postoperative Baseline to 3 Months After Discharge From the Hospital
timeFrame: 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:
measure: Rate of Placement to Skilled Nursing Facility After Hospital Discharge
timeFrame: 13 weeks after hospital discharge
measure: Rate of 90 Day Hospital Readmission After Hospital Discharge
timeFrame: 90 days after hospital discharge
measure: Rate of Postoperative Complications
timeFrame: Immediately after the surgery to 3 months postoperatively
measure: Rate of Postoperative Delirium
timeFrame: Immediately after the surgery to 3 months postoperatively
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Daniel Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: