Decision Making for Urinary Diversion in Patients With Bladder Cancer

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT05111639
Collaborator
American Urological Association (Other)
300
1
46
6.5

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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 :
    Aug 23, 2021
    Anticipated Primary Completion Date :
    Jun 22, 2023
    Anticipated Study Completion Date :
    Jun 22, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Acceptability of the decision aid tool [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 [12 months]

      qualitative analysis of interview data

    2. Decisional Quality [12 months]

      assessed via decisional conflict (Decisional Conflict Scale, O'Connor, 1993 updated 2005), http://www.ohri.ca/decisionaid/

    3. Decisional Regret [12 months]

      Decision Regret Scale, O'connor, 1996, University of Ottawa

    4. Value Concordance [12 months]

      a combination of the above decision quality and regret surveys as well as qualitative analysis of interview data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Colorado Health Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • American Urological Association

    Investigators

    • Principal Investigator: Janet Kukreja, Colorado Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT05111639
    Other Study ID Numbers:
    • 21-3661.cc
    First Posted:
    Nov 8, 2021
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 8, 2021