Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

Not Applicable

Completed

• Conditions: Stoma Ileostomy
• Interventions: Behavioral: Stoma Boot Camp; Other: Standard of Care

• Registration Number: NCT03462667
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to learn if the stoma boot camp is a good and effective way to help people adapt to life with a stoma after surgery.

Detailed Description

Bladder cancer is the fifth most common cancer in the USA. The primary treatment for invasive bladder cancer is a radical cystectomy (RC) with a urinary diversion. Patients that have this procedure must deal with a stoma that requires daily care and manual skills. A stoma is an artificial opening that allows urine to pass from the ureters outside the body. Having a surgery that results in a stoma can dramatically change a person's life.

This study is being done to test a new education session called the stoma boot camp. The session was created to help people deal with changes in their post-surgery life and living with a stoma.

The session requires a one time visit to the study site and lasts about two hours. Participants can bring a support person to the boot camp if they choose. During the two hour session, nurses will provide teaching, counseling, and hands on practice with an artificial stoma.

Study Timeline

• Study First Submitted: 2018-02-23
• Study Start: 2018-02-26
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-12
• Primary Completion: 2019-08-01
• Study Completion: 2020-03-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Patients must be presumed to undergo a radical cystectomy with ileal conduit diversion
• Diagnosis of bladder cancer

Exclusion Criteria

• Patients undergoing a radical cystectomy with ileal conduit for any reason other than bladder cancer will not be allowed to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stoma Boot Camp	Stoma Boot Camp	Participants will attend the Stoma Boot Camp session prior to surgery.
Regular Care	Standard of Care	Participants will receive normal standard of care prior to surgery.

Primary Outcome Measures

Name	Time	Method
Ostomy adjustment scale	Change from Baseline to 30 Days After Date of Surgery	The Ostomy Adjustment Scale evaluates a person with an ostomy following surgery. The instrument consists of 34 statements. Scores range from a minimum of 34 to a maximum of 204. The higher the score, the better the person's perceived adjustment.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Date of Admission to Date of Discharge, up to 7 days	Measured as the date of admission to discharge.
Count of un-planned stoma-related interventions in community after discharge	30 Days After Date of Surgery	Unplanned stoma-related interventions will include any admission to any hospital after being discharged, from the time the patient goes home up until 30 days after the date of the surgery, along with any stoma related visit outside of the normal follow-up pathway to a clinic or any stoma related phone calls received by urology or ostomy staff.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States