Bladder CancerNCT05111639
Decision Making for Urinary Diversion in Patients With Bladder Cancer
An observational study of Bladder Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This proposal will aim to improve the understanding about the treatment decision in the type of urinary diversion and identify patient knowledge gaps about uncertainty around patient decision-making. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2021to 21 Feb 2025
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants (patients and urologists) will be recruited for qualitative interviews as follows: 1) 10 bladder cancer patients who have undergone urinary diversion within the last year; 2) 10 bladder cancer patients who are undergoing urinary diversion in the next 3 months; and 3) 10 individual interviews will be done with urologists currently performing cystectomy and urinary diversions.
Who may be able to join
- Any patient undergoing or who has undergone urinary diversion for bladder cancer
- <90 years old
Who cannot join
- Any patient undergoing or undergone urinary diversion for other reason than bladder cancer
- aged >90 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health
Aurora, Colorado, 80045
About this study
This proposal will aim to improve the understanding about the treatment decision in the type of urinary diversion and identify patient knowledge gaps about uncertainty around patient decision-making.
Read the detailed description
The Investigator aims to elicit the patient and provider experiences through conducting a 90-minute interview, using an interview guide the research team has developed, using established qualitative research methods for in-depth individual interviews. The team will structure the interviews with broad, open-ended questions to elicit personal thoughts, emotions and experiences regarding decision making for urinary diversion. The team will use the information collected from this interview to make a tool valuable in developing a patient decision aid. For patients who have not undergone surgery yet, the team will ask the patient if it is okay to contact after their surgery to reassess the patients responses to the same questions from the first interview.
In Aim 2, the team will complete part one of the Ottawa decision framework by assessing the patients' and urologists' determinates of decisions for urinary diversion and identify support needs. Using established qualitative research methods for in-depth individual interviews, the team will structure the interviews with broad, open-ended questions to elicit personal thoughts, emotions and experiences regarding decision making for urinary diversion.
Informed by Aim 2 the team will develop a web-based development of a decision aid. The development process will use both the Ottawa decision support and IPDAS to center the design empathetic to the user. The aim will be consistent with principles where the users take priority in the IPDAS guidelines framework and the needs assessment framework. The team will develop a decision support tailored to patients needs who are undergoing urinary diversion and then evaluate the decision making process. The decision aid will use the preferences from the themes of the individual interviews to give patients a preferred method of urinary diversion. The team will perform this in a pre-post fashion.
As mentioned previously, patients will be recruited from the urologists' clinical work. The Indiana and Neobladder patients may have different vantage points in the perioperative period, however at 6-months this should no longer be different. In addition, the team will have patients use the decision aid at 1-month postoperatively to obtain feedback. Getting patient feedback from the group will be critical with such a large number of patients recruited. The research assistant will identify eligible patients prior to their clinic encounter and obtain informed consent. Patients will then complete the decision aid prior to the visit with the surgeon and bring the completed tool into the clinical encounter. After completing the visit, the patient and research assistant will complete the questionnaires assessing acceptability, knowledge, treatment decision and decisional conflict. One month after surgery, our team will also complete the same questionnaires, as well as patient satisfaction and regret at the 6-month follow-up visit. If patients are not available for the visit, our team will attempt to complete telehealth or telephone interviews.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the decision aid tool
Matlock DD, Keech TA, McKenzie MB, Bronsert MR, Nowels CT, Kutner JS. Feasibility and acceptability of a decision aid designed for people facing advanced or terminal illness: a pilot randomized trial.
Measured: 12 months
Secondary outcomes (4)
Knowledge
qualitative analysis of interview data
Measured: 12 months
Decisional Quality
assessed via decisional conflict (Decisional Conflict Scale, O'Connor, 1993 updated 2005), http://www.ohri.ca/decisionaid/
Measured: 12 months
Decisional Regret
Decision Regret Scale, O'connor, 1996, University of Ottawa
Measured: 12 months
Value Concordance
a combination of the above decision quality and regret surveys as well as qualitative analysis of interview data
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start24 Aug 2021
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
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 Colorado, DenverThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Urological Association
- Responsible party
- Sponsor
- Investigators
- Janet Kukreja, Principal investigator, Colorado Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111639
- Sponsor's protocol ID
- 21-3661.cc
- Other IDs
- NCI-2021-10463
- Status last verified
- Aug 2025
- First submitted
- 19 Oct 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making for Urinary Diversion in Patients With Bladder Cancer
- ClinicalTrials.gov ID
- NCT05111639
- Acronym / sponsor ID
- 21-3661.cc
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Urological Association
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 8 Nov 2021 (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 proposal will aim to improve the understanding about the treatment decision in the type of urinary diversion and identify patient knowledge gaps about uncertainty around patient decision-making.
Detailed description
The Investigator aims to elicit the patient and provider experiences through conducting a 90-minute interview, using an interview guide the research team has developed, using established qualitative research methods for in-depth individual interviews. The team will structure the interviews with broad, open-ended questions to elicit personal thoughts, emotions and experiences regarding decision making for urinary diversion. The team will use the information collected from this interview to make a tool valuable in developing a patient decision aid. For patients who have not undergone surgery yet, the team will ask the patient if it is okay to contact after their surgery to reassess the patients responses to the same questions from the first interview.
In Aim 2, the team will complete part one of the Ottawa decision framework by assessing the patients' and urologists' determinates of decisions for urinary diversion and identify support needs. Using established qualitative research methods for in-depth individual interviews, the team will structure the interviews with broad, open-ended questions to elicit personal thoughts, emotions and experiences regarding decision making for urinary diversion.
Informed by Aim 2 the team will develop a web-based development of a decision aid. The development process will use both the Ottawa decision support and IPDAS to center the design empathetic to the user. The aim will be consistent with principles where the users take priority in the IPDAS guidelines framework and the needs assessment framework. The team will develop a decision support tailored to patients needs who are undergoing urinary diversion and then evaluate the decision making process. The decision aid will use the preferences from the themes of the individual interviews to give patients a preferred method of urinary diversion. The team will perform this in a pre-post fashion.
As mentioned previously, patients will be recruited from the urologists' clinical work. The Indiana and Neobladder patients may have different vantage points in the perioperative period, however at 6-months this should no longer be different. In addition, the team will have patients use the decision aid at 1-month postoperatively to obtain feedback. Getting patient feedback from the group will be critical with such a large number of patients recruited. The research assistant will identify eligible patients prior to their clinic encounter and obtain informed consent. Patients will then complete the decision aid prior to the visit with the surgeon and bring the completed tool into the clinical encounter. After completing the visit, the patient and research assistant will complete the questionnaires assessing acceptability, knowledge, treatment decision and decisional conflict. One month after surgery, our team will also complete the same questionnaires, as well as patient satisfaction and regret at the 6-month follow-up visit. If patients are not available for the visit, our team will attempt to complete telehealth or telephone interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants (patients and urologists) will be recruited for qualitative interviews as follows: 1) 10 bladder cancer patients who have undergone urinary diversion within the last year; 2) 10 bladder cancer patients who are undergoing urinary diversion in the next 3 months; and 3) 10 individual interviews will be done with urologists currently performing cystectomy and urinary diversions.
Key inclusion criteria (2 listed)
- Any patient undergoing or who has undergone urinary diversion for bladder cancer
- <90 years old
Key exclusion criteria (2 listed)
- Any patient undergoing or undergone urinary diversion for other reason than bladder cancer
- aged >90 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability of the decision aid tool
Time frame: 12 months
Matlock DD, Keech TA, McKenzie MB, Bronsert MR, Nowels CT, Kutner JS. Feasibility and acceptability of a decision aid designed for people facing advanced or terminal illness: a pilot randomized trial.
4 secondary outcomes
Knowledge
Time frame: 12 months
Decisional Quality
Time frame: 12 months
Decisional Regret
Time frame: 12 months
Value Concordance
Time frame: 12 months
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 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Janet Kukreja principal investigator
Colorado Research Center
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, run by University of Colorado, Denver 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 2 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 14 Aug 2025. 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?
Acceptability of the decision aid tool (time frame: 12 months). 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 14 Aug 2025.