Stoma IleostomyStomABCNCT03462667
Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient
A study testing Stoma Boot Camp in people with Stoma Ileostomy, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Ileostomy
- What is being tested?
- Stoma Boot Camp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be presumed to undergo a radical cystectomy with ileal conduit diversion
- Diagnosis of bladder cancer
Who cannot join
- Patients undergoing a radical cystectomy with ileal conduit for any reason other than bladder cancer will not be allowed to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the 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.
- Conditions
- Stoma Ileostomy
- Being tested
- Stoma Boot Camp, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoma Boot CampBehavioural
Educational session designed to prepare people for living life with a stoma.
Standard of CareOther
Patients receive normal pre-surgery standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Stoma Boot Camp | Experimental | Participants will attend the Stoma Boot Camp session prior to surgery. Receives: Behavioral: Stoma Boot Camp |
| Regular Care | Active comparator | Participants will receive normal standard of care prior to surgery. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 30 Days After Date of Surgery
Secondary outcomes (2)
Length of hospital stay
Measured as the date of admission to discharge.
Measured: 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.
Measured: 30 Days After Date of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start26 Feb 2018
- Primary completion1 Aug 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma IleostomyStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moben Mirza, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462667
- Sponsor's protocol ID
- STUDY00142039
- Acronym
- StomABC
- Status last verified
- Sep 2020
- First submitted
- 23 Feb 2018
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient
- ClinicalTrials.gov ID
- NCT03462667
- Acronym / sponsor ID
- StomABC / STUDY00142039
- Conditions
- Stoma Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stoma Boot Camp | Experimental | Behavioral: Stoma Boot CampParticipants will attend the Stoma Boot Camp session prior to surgery. |
| Regular Care | Active comparator | Other: Standard of CareParticipants will receive normal standard of care prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be presumed to undergo a radical cystectomy with ileal conduit diversion
- Diagnosis of bladder cancer
Key exclusion criteria (1 listed)
- Patients undergoing a radical cystectomy with ileal conduit for any reason other than bladder cancer will not be allowed to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stoma Boot CampEducational session designed to prepare people for living life with a stoma. | Behavioural | Stoma Boot Camp |
| Standard of CarePatients receive normal pre-surgery standard of care. | Other | Regular Care |
Primary outcome
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.
2 secondary outcomes
Length of hospital stay
Time frame: Date of Admission to Date of Discharge, up to 7 days
Count of un-planned stoma-related interventions in community after discharge
Time frame: 30 Days After Date of Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moben Mirza, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stoma Boot Camp in people with Stoma Ileostomy, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ostomy adjustment scale (time frame: Change from Baseline to 30 Days After Date of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.