Use of Pedometer Following Radical Cystectomy

NCT ID: NCT04305730

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2021-05-31

Brief Summary

This is a study to evaluate whether use of a pedometer following radical cystectomy decreases post-operative narcotic use and time to return of bowel function.

Detailed Description

This is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical cystectomy on rate of ileus, return of bowel function and post-operative narcotic use. Subjects will be randomized into a control group or study group. The control group will receive standard of care, with information provided regarding the importance of ambulation following surgery. The study group will receive a pedometer with graduated step-count goals from post-operative day 0 to post-operative day 21. Both groups will be given a standardized post-operative narcotic regimen, and will be asked to record initial passage of flatus and first bowel movement. Subjects will remain on the study until post-operative day 21.

Conditions

Bladder Cancer; Ileus; Narcotic Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pedometer Group

This group will be given a pedometer following radical cystectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 1,000/day. POD 3-6: 2,000/day. POD 7-9: 3,000/day. POD 10-14: 4,000/day. POD 14-21: 5,000

Group Type: EXPERIMENTAL

Use of a pedometer following surgery

Intervention Type: BEHAVIORAL

Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.

Control group

This is the control group. Following radical cystectomy subjects in the control group will receive standard of care, which includes counseling regarding the importance of ambulation following surgery.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: BEHAVIORAL

Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.

Interventions

Use of a pedometer following surgery

Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.

Intervention Type: BEHAVIORAL

Standard of care

Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

This study will include men and women age18-75 undergoing radical cystectomy for bladder cancer at Virginia Mason Medical Center. This includes both open and robot-assisted radical cystectomy, and all types of urinary diversion will be included in the trial. Subjects both with and without neo-adjuvant chemotherapy will be included in the study.

Exclusion Criteria

• Long-term opioid use, defined by CDC as use of opioids on most days for >3 months
• History of inflammatory bowel disease
• Prior abdominopelvic radiation
• Travel to Europe during study period
• Concurrent surgery during radical cystectomy
• Inability to ambulate
• Gastroparesis or other baseline bowel dysmotility issues
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Mason Hospital/Medical Center

OTHER

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Corman, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

Central Contacts

Basil Ferenczi, MD

Role: CONTACT

basil.ferenczi@virginiamason.org

206-223-6600

Facility Contacts

Basil A Ferenczi, MD

Role: primary

basil.ferenczi@virginiamason.org

206-223-6772

Other Identifiers

IRB 20-020

Identifier Type: -

Identifier Source: org_study_id