Use of Pedometer Following Radical Prostatectomy

NCT04206280 | Unknown

• 1 other identifier: IRB19-096
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer; Ambulation Difficulty

Keywords

radical prostatectomy; pedometer; return of bowel function; post-operative narcotic use

Outcome Measures

Primary Outcomes (1)

• Post operative narcotic use

  Morphine equivalents used following radical prostatectomy.

  7-14 days

Secondary Outcomes (1)

• Rate of return of bowel function

  7-14 days

Study Arms (2)

Pedometer group

EXPERIMENTAL

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

Behavioral: Use of a pedometer following surgery

Control group

ACTIVE COMPARATOR

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

Behavioral: Standard of care

Interventions

Use of a pedometer following surgery BEHAVIORAL

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

Pedometer group

Standard of care BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This study will include men 18-75 undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer at Virginia Mason Medical Center.

You may not qualify if:

• 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 prostatectomy
• Inability to ambulate
• Gastroparesis or other baseline bowel dysmotility issues
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Virginia Mason Hospital/Medical Center: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Mobility Limitation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• John Corman, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basil Ferenczi, MD

CONTACT

206-223-6600; basil.ferenczi@virginiamason.org

Study Design

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

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: February 10, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: February 11, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)