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Completed

NCT Number: NCT04314778

FITBIT Study on Mobility and Readmissions After Radical Cystectomy

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center, Philadelphia, Pennsylvania, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge

    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

    Change in mean daily step count

Secondary outcomes

  1. Change in Mean Daily Step Count From the Postoperative Baseline to 3 Months After Discharge From the Hospital

    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

    Change in mean daily step count

Other outcomes

  1. Rate of Placement to Skilled Nursing Facility After Hospital Discharge

    Time frame: 13 weeks after hospital discharge

    Rate of placement to skilled nursing facility postoperatively

  2. Rate of 90 Day Hospital Readmission After Hospital Discharge

    Time frame: 90 days after hospital discharge

    Rate of 90 day hospital readmission

  3. Rate of Postoperative Complications

    Time frame: Immediately after the surgery to 3 months postoperatively

    Rate of complications after the surgery

  4. Rate of Postoperative Delirium

    Time frame: Immediately after the surgery to 3 months postoperatively

    Rate of delirium after the surgery

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: FITBIT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2020
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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