Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

NCT ID: NCT03462667

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2020-03-01

Brief Summary

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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

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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.

Conditions

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Stoma Ileostomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Stoma Boot Camp

Participants will attend the Stoma Boot Camp session prior to surgery.

Group Type EXPERIMENTAL

Stoma Boot Camp

Intervention Type BEHAVIORAL

Educational session designed to prepare people for living life with a stoma.

Regular Care

Participants will receive normal standard of care prior to surgery.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Patients receive normal pre-surgery standard of care.

Interventions

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Stoma Boot Camp

Educational session designed to prepare people for living life with a stoma.

Intervention Type BEHAVIORAL

Standard of Care

Patients receive normal pre-surgery standard of care.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moben Mirza, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00142039

Identifier Type: -

Identifier Source: org_study_id

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