Bladder Cancer
Conditions
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
Interventions
BEHAVIORALsocial 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).
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge | 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 | Change in mean daily step count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Change in mean daily step count |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Placement to Skilled Nursing Facility After Hospital Discharge | 13 weeks after hospital discharge | Rate of placement to skilled nursing facility postoperatively |
| Rate of 90 Day Hospital Readmission After Hospital Discharge | 90 days after hospital discharge | Rate of 90 day hospital readmission |
| Rate of Postoperative Complications | Immediately after the surgery to 3 months postoperatively | Rate of complications after the surgery |
| Rate of Postoperative Delirium | Immediately after the surgery to 3 months postoperatively | Rate of delirium after the surgery |
Countries
United States
Participant flow
Pre-assignment details
64 participants gave informed consent but 3 participants declined to complete required pre-randomization surveys. These participants were not assigned to intervention or control groups and were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day.
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). | 30 |
| Control Participants in the control group will have data collected passively via Fitbit. | 31 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 3 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 12.4 | 66.2 years STANDARD_DEVIATION 11.3 | 65.3 years STANDARD_DEVIATION 10.2 |
| Race/Ethnicity, Customized Black, non-Hispanic | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 6 Participants | 15 Participants | 9 Participants |
| Sex: Female, Male Male | 25 Participants | 46 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 0 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 |
Outcome results
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
Time frame: 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
Population: Only 23 participants had recorded step count data of more than two days while in the hospital. This clinical trial was performed during the height of the COVID-19 pandemic when research staff and hospital staff were not allowed in the hospital or on University campuses, making follow up in the hospital difficult while patients were recovering from a major surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge | 1087 mean change in daily steps |
| Control | Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge | 995 mean change in daily steps |
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
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Mean Daily Step Count From the Postoperative Baseline to 3 Months After Discharge From the Hospital | 5674 mean change in daily steps | Standard Deviation 3681 |
| Control | Change in Mean Daily Step Count From the Postoperative Baseline to 3 Months After Discharge From the Hospital | 4660 mean change in daily steps | Standard Deviation 3063 |
Other Pre-specified
Rate of 90 Day Hospital Readmission After Hospital Discharge
Rate of 90 day hospital readmission
Time frame: 90 days after hospital discharge
Other Pre-specified
Rate of Placement to Skilled Nursing Facility After Hospital Discharge
Rate of placement to skilled nursing facility postoperatively
Time frame: 13 weeks after hospital discharge
Other Pre-specified
Rate of Postoperative Complications
Rate of complications after the surgery
Time frame: Immediately after the surgery to 3 months postoperatively
Other Pre-specified
Rate of Postoperative Delirium
Rate of delirium after the surgery
Time frame: Immediately after the surgery to 3 months postoperatively