Steps to Eliminate Postoperative Problems

NCT02880176 | Completed Results

• 2 other identifiers: 825215UL1TR000003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Bladder Cancer

Keywords

Behavioral Economics; Financial Incentives; Bladder Cancer; Ambulation; Surgical Co-Morbidity; Fitbit; Mobile Health; Radical Cystectomy

Outcome Measures

Primary Outcomes (1)

• Number of Days Step Goal Completed

  Number of days during the study period that each subject reaches their step goal

  30 days

Secondary Outcomes (3)

• Number of Steps Taken Per Day

  30 days

• Composite Morbidity Outcome of Complications, Unplanned Readmissions, or Emergency Department Visits

  30 days

• Functional Decline as Assessed by the Stanford Health Assessment Questionnaire (SHAQ)

  1 months

Study Arms (2)

Financial Incentive

EXPERIMENTAL

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

Other: Financial Incentive to Increase Ambulation

Control (Education)

NO INTERVENTION

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

Interventions

Financial Incentive to Increase Ambulation OTHER

Financial Incentive and possibility for financial lottery entry in addition to education on the benefits of post-surgery ambulation

Financial Incentive

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Children's Hospital of Philadelphia: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (45)

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MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Marshall Strother
• Organization: Fox Chase Cancer Center

m12912988@gmail.com

555-555-5555

Study Officials

• Gregory Tasian, MD,MSc,MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Thomas Guzzo, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 9, 2021
• Results First Posted: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)