Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day. |
|
| Control | No Intervention | Participants in the control group will have data collected passively via Fitbit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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. As the time to discharge was variable, this time period was up to 60 days after surgery |
| 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. This time was up to 3 months after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Placement to Skilled Nursing Facility After Hospital Discharge | Rate of placement to skilled nursing facility postoperatively | 13 weeks after hospital discharge |
| Rate of 90 Day Hospital Readmission After Hospital Discharge |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Lee, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Pennsylvania |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Control | Participants in the control group will have data collected passively via Fitbit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 64 patients gave informed consent but only 61 completed run-in and were randomized. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | Posted | Mean | 95% Confidence Interval | mean change in daily steps | 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 |
|
Adverse event data was collected for the study period of 6 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| S. Ryan Greysen, MD (Principal Investigator) | University of Pennsylvania | 215-614-0095 | Ryan.Greysen@pennmedicine.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2019 | Jun 12, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Rate of 90 day hospital readmission
| 90 days after hospital discharge |
| Rate of Postoperative Complications | Rate of complications after the surgery | Immediately after the surgery to 3 months postoperatively |
| Rate of Postoperative Delirium | Rate of delirium after the surgery | Immediately after the surgery to 3 months postoperatively |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| BG001 | Control | Participants in the control group will have data collected passively via Fitbit. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Control | Participants in the control group will have data collected passively via Fitbit. |
|
|
| 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 | Posted | Mean | Standard Deviation | mean change in daily steps | 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 Pre-specified | Rate of Placement to Skilled Nursing Facility After Hospital Discharge | Rate of placement to skilled nursing facility postoperatively | Not Posted | 13 weeks after hospital discharge | Participants |
| Other Pre-specified | Rate of 90 Day Hospital Readmission After Hospital Discharge | Rate of 90 day hospital readmission | Not Posted | 90 days after hospital discharge | Participants |
| Other Pre-specified | Rate of Postoperative Complications | Rate of complications after the surgery | Not Posted | Immediately after the surgery to 3 months postoperatively | Participants |
| Other Pre-specified | Rate of Postoperative Delirium | Rate of delirium after the surgery | Not Posted | Immediately after the surgery to 3 months postoperatively | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | Participants in the control group will have data collected passively via Fitbit. | 0 | 31 | 0 | 31 | 0 | 31 |
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |