Clinical trial · Interventional
Steps to Eliminate Postoperative Problems
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Financial Incentive to Increase Ambulation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Financial Incentive
- description
- Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days. Subjects will use Fitbit Zip to track step counts
- interventionNames
- Other: Financial Incentive to Increase Ambulation
- type
- NO_INTERVENTION
- label
- Control (Education)
- description
- Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts
Primary outcomes (1)
- measure
- Number of Days Step Goal Completed
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (45)
- BACKGROUNDStimson CJ, Chang SS, Barocas DA, Humphrey JE, Patel SG, Clark PE, Smith JA Jr, Cookson MS. Early and late perioperative outcomes following radical cystectomy: 90-day readmissions, morbidity and mortality in a contemporary series. J Urol. 2010 Oct;184(4):1296-300. doi: 10.1016/j.juro.2010.06.007. Epub 2010 Aug 17. PMID 20723939
- BACKGROUNDGandaglia G, Varda B, Sood A, Pucheril D, Konijeti R, Sammon JD, Sukumar S, Menon M, Sun M, Chang SL, Montorsi F, Kibel AS, Trinh QD. Short-term perioperative outcomes of patients treated with radical cystectomy for bladder cancer included in the National Surgical Quality Improvement Program (NSQIP) database. Can Urol Assoc J. 2014 Sep;8(9-10):E681-7. doi: 10.5489/cuaj.2069. PMID 25408807
- BACKGROUNDTan HJ, Kaplan AL, Chuang RJ, Kwan L, Filson CP, Litwin MS. The Cost Burden of Complications after Major Surgery for Urological Cancer: Opportunities for Value Creation in Urology. Urol Pract. 2016 Mar;3(2):81-89. doi: 10.1016/j.urpr.2015.05.002. Epub 2015 Dec 29. PMID 37592482
- BACKGROUNDPashikanti L, Von Ah D. Impact of early mobilization protocol on the medical-surgical inpatient population: an integrated review of literature. Clin Nurse Spec. 2012 Mar-Apr;26(2):87-94. doi: 10.1097/NUR.0b013e31824590e6. PMID 22336934
- BACKGROUNDRaue W, Haase O, Junghans T, Scharfenberg M, Muller JM, Schwenk W. 'Fast-track' multimodal rehabilitation program improves outcome after laparoscopic sigmoidectomy: a controlled prospective evaluation. Surg Endosc. 2004 Oct;18(10):1463-8. doi: 10.1007/s00464-003-9238-y. Epub 2004 Aug 26. PMID 15791370
- BACKGROUNDPadula CA, Hughes C, Baumhover L. Impact of a nurse-driven mobility protocol on functional decline in hospitalized older adults. J Nurs Care Qual. 2009 Oct-Dec;24(4):325-31. doi: 10.1097/NCQ.0b013e3181a4f79b. PMID 19395979
- Baird G, Maxson P, Wrobleski D, Luna BS. Fast-track colorectal surgery program reduces hospital length of stay. Clin Nurse Spec. 2010 Jul-Aug;24(4):202-8. doi: 10.1097/NUR.0b013e3181e3604c.