Steps to Eliminate Postoperative Problems

Completed · Not applicable

Conditions studied: Bladder Cancer

In brief

Radical cystectomy with urinary diversion is associated with substantial perioperative morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases the risk of readmission, and adds substantially to health care costs. Protocols that emphasize early and frequent ambulation after surgery decreases post-operative morbidity, but poor patient adherence diminishes the effectiveness of these protocols, which are currently implemented only during the hospital stay. Financial incentives overcome present bias and offer a novel and practical approach to increasing ambulation during the post-operative period in the hospital and also after discharge. This application proposes a pilot randomized, controlled trial to estimate the effect size of financial incentives on achieving a patient-specific daily step goal in the hospital and post-discharge for 1 month following radical cystectomy. Secondary outcomes include step count, composite morbidity, and functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy at the Hospital of the University of Pennsylvania will be randomized to either control (education of step goal with monitoring and daily feedback) or a gain financial incentive combined with a lottery incentive if they achieve 75% of the daily goals during the study period. Fitbit Zips will be used to measure step counts for all participants. This proposal will provide the preliminary data needed to design future, larger trials that will test the effect of financial incentives to increase ambulation on post operative complications, readmissions, and functional decline.

Key facts

Study ID: NCT02880176
Run by: University of Pennsylvania
People needed: 34
Starts: 2016-08-01
Expected to finish: 2019-02-01
Last updated by the study team: 2021-03-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Planning to undergo radical cystectomy (either with ileal conduit, Indiana pouch, neobladder (e.g., Studer or Hautmann pouch) at the University of Pennsylvania
Patient has been diagnosed with bladder cancer
Patient is at least 21 years of age
Patient is ambulatory with baseline ECOG performance status less than or equal to 2

You may not qualify if…

Patient knows he or she will be unable or unwilling to use a mobile device and online tool to upload activity data
Poor preoperative performance status (ECOG 3 or greater)
Plan for cystectomy without cutaneous ureterostomies (without a bowel diversion)
Non-English speakers
Patient is non-ambulatory
Patient is incapable of consenting himself or herself prior to surgery (Because participating in this trial involves ongoing effort on the part of the subject, patients who are incapable of consenting for themselves at baseline are excluded)
Patients who do not have at least 24 hours of pre-operation ambulation data

Where it is running

Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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