Bladder CancerStomABC ImpactNCT04334226
The Impact of Preoperative Urostomy Education on Patients and Families
An observational study of Bladder Cancer and Urostomy, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This is an observational study utilizing a qualitative descriptive methodology with a thematic analysis approach to explore the impact of a preoperative educational intervention ("Stoma Bootcamp") on patients and their family/informal caregivers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urostomy
- What is being tested?
- Interview
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2020to 31 Jul 2020
- Phase
- Observational
- 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
Study population: Patients who underwent radical cystectomy for bladder cancer at the University of Kansas Medical Center and participated in Stoma Botcamp and their caregivers
Who may be able to join
- Adult (age ≥ 18 years) patients who underwent radical cystectomy for bladder cancer at the University of Kansas Medical Center since 2016, AND
- Participated in the Stoma Bootcamp preoperative educational intervention, AND
- Identified an informal/family caregiver who participated in Stoma Bootcamp with them.
- Patient-caregiver dyads must both consent to participation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
This is an observational study utilizing a qualitative descriptive methodology with a thematic analysis approach to explore the impact of a preoperative educational intervention ("Stoma Bootcamp") on patients and their family/informal caregivers
Read the detailed description
This study will utilize a qualitative descriptive methodology with a thematic analysis approach. Individual interviews will be held with bladder cancer and caregiver dyads who participated in the Stoma Bootcamp study. Interviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the Bootcamp and after the Bootcamp from a physical, psychological, social, and spiritual perspective. Semi-structured interview guides will be developed using Engel Biopsychosocial Model (BPS),5 one guide geared towards patients and the second toward caregivers.
- Conditions
- Bladder Cancer, Urostomy
- Being tested
- Interview
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Interviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the Bootcamp and after the Bootcamp from a physical, psychological, social, and spiritual perspective
| Study group | Role | What they receive |
|---|---|---|
| Patient and Caregiver Dyad | Individuals who participated in the Stoma Boot Camp study and their caregiver will form a dyad Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Stoma Bootcamp preoperative educational program on patients and caregivers
The research team will open code a subset of interviews, develop a codebook, and continue rounds of coding and discussion until consensus on code and definitions is reached. Once consensus is reached, all transcripts will be coded using the codebook, categories will be developed, and emergent themes will be assessed. Once themes are identified, they will be placed into a thematic map. Data will be analyzed until thematic saturation is reached
Measured: Interviews are expected to last 10-20 minutes and analysis expected to last approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start3 Mar 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Wulff-Burchfield, MD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334226
- Sponsor's protocol ID
- 145269
- Acronym
- StomABC Impact
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2020
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative Urostomy Education on Patients and Families
- ClinicalTrials.gov ID
- NCT04334226
- Acronym / sponsor ID
- StomABC Impact / 145269
- Conditions
- Bladder Cancer, Urostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 6 Apr 2020 (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.
This is an observational study utilizing a qualitative descriptive methodology with a thematic analysis approach to explore the impact of a preoperative educational intervention ("Stoma Bootcamp") on patients and their family/informal caregivers
Detailed description
This study will utilize a qualitative descriptive methodology with a thematic analysis approach. Individual interviews will be held with bladder cancer and caregiver dyads who participated in the Stoma Bootcamp study. Interviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the Bootcamp and after the Bootcamp from a physical, psychological, social, and spiritual perspective. Semi-structured interview guides will be developed using Engel Biopsychosocial Model (BPS),5 one guide geared towards patients and the second toward caregivers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient and Caregiver Dyad | – | Other: InterviewIndividuals who participated in the Stoma Boot Camp study and their caregiver will form a dyad |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent radical cystectomy for bladder cancer at the University of Kansas Medical Center and participated in Stoma Botcamp and their caregivers
Key inclusion criteria (4 listed)
- Adult (age ≥ 18 years) patients who underwent radical cystectomy for bladder cancer at the University of Kansas Medical Center since 2016, AND
- Participated in the Stoma Bootcamp preoperative educational intervention, AND
- Identified an informal/family caregiver who participated in Stoma Bootcamp with them.
- Patient-caregiver dyads must both consent to participation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| InterviewInterviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the Bootcamp and after the Bootcamp from a physical, psychological, social, and spiritual perspective | Other | Patient and Caregiver Dyad |
Primary outcome
Impact of Stoma Bootcamp preoperative educational program on patients and caregivers
Time frame: Interviews are expected to last 10-20 minutes and analysis expected to last approximately one year
The research team will open code a subset of interviews, develop a codebook, and continue rounds of coding and discussion until consensus on code and definitions is reached. Once consensus is reached, all transcripts will be coded using the codebook, categories will be developed, and emergent themes will be assessed. Once themes are identified, they will be placed into a thematic map. Data will be analyzed until thematic saturation is reached
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 4 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Urostomy, 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 4 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 4 Mar 2021. 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?
Impact of Stoma Bootcamp preoperative educational program on patients and caregivers (time frame: Interviews are expected to last 10-20 minutes and analysis expected to last approximately one year). 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 4 Mar 2021.