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Decision Making for Urinary Diversion in Patients With Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05111639
Recruitment Status : Recruiting
First Posted : November 8, 2021
Last Update Posted : November 1, 2022
Sponsor:
Collaborator:
American Urological Association
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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.

Condition or disease
Bladder Cancer

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
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decision Making for Urinary Diversion in Patients With Bladder Cancer
Actual Study Start Date : August 23, 2021
Estimated Primary Completion Date : June 22, 2023
Estimated Study Completion Date : June 22, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Knowledge [ Time Frame: 12 months ]
    qualitative analysis of interview data

  2. Decisional Quality [ Time Frame: 12 months ]
    assessed via decisional conflict (Decisional Conflict Scale, O'Connor, 1993 updated 2005), http://www.ohri.ca/decisionaid/

  3. Decisional Regret [ Time Frame: 12 months ]
    Decision Regret Scale, O'connor, 1996, University of Ottawa

  4. Value Concordance [ Time Frame: 12 months ]
    a combination of the above decision quality and regret surveys as well as qualitative analysis of interview data


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Any patient undergoing or who has undergone urinary diversion for bladder cancer
  • <90 years old

Exclusion Criteria:

  • Any patient undergoing or undergone urinary diversion for other reason than bladder cancer
  • aged >90 years old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05111639


Contacts
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Contact: Ashley Dafoe 3037240838 ashley.dafoe@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Health Recruiting
Aurora, Colorado, United States, 80045
Contact: Janet Kukreja, MD    816-830-5699    janet.kukreja@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
American Urological Association
Investigators
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Principal Investigator: Janet Kukreja Colorado Research Center
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05111639    
Other Study ID Numbers: 21-3661.cc
First Posted: November 8, 2021    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases