Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

Stoma Ileostomy Clinical Trial

— StomABC  

Official title:

Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462667
• Other study ID #: STUDY00142039
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stoma Ileostomy

Intervention

Behavioral:
• Stoma Boot Camp
Educational session designed to prepare people for living life with a stoma.

Other:
• Standard of Care
Patients receive normal pre-surgery standard of care.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ostomy adjustment scale	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.	Change from Baseline to 30 Days After Date of Surgery
Secondary	Length of hospital stay	Measured as the date of admission to discharge.	Date of Admission to Date of Discharge, up to 7 days
Secondary	Count of un-planned stoma-related interventions in community after discharge	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.	30 Days After Date of Surgery