Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

Study Overview
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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.

Official Title
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Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

Conditions
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Stoma Ileostomy

Intervention / Treatment
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* Behavioral: Stoma Boot Camp
* Other: Standard of Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stoma Boot Camp<br>Participants will attend the Stoma Boot Camp session prior to surgery. | Behavioral: Stoma Boot Camp<br>* Educational session designed to prepare people for living life with a stoma.<br>|
| Active Comparator: Regular Care<br>Participants will receive normal standard of care prior to surgery. | Other: Standard of Care<br>* Patients receive normal pre-surgery standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Measured as the date of admission to discharge. | Date of Admission to Date of Discharge, up to 7 days | 
| 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 |