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Completed

NCT Number: NCT03462667

Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

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.

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Key information

Conditions

Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stoma Boot Camp

Behavioral

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

Standard of care

Other

Patients receive normal pre-surgery standard of care.

Primary outcomes

  1. Ostomy adjustment scale

    Time frame: 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 outcomes

  1. Length of hospital stay

    Time frame: Date of Admission to Date of Discharge, up to 7 days

    Measured as the date of admission to discharge.

  2. Count of un-planned stoma-related interventions in community after discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: StomABC

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 12, 2018
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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