Decision Making for Urinary Diversion in Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Decision Making for Urinary Diversion in Patients With Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05111639
• Other study ID #: 21-3661.cc
• Status: Recruiting
• Start date: August 24, 2021
• Est. completion date: June 22, 2025

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Ashley Dafoe
• Phone: 3037240838
• Email: ashley.dafoe[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 22, 2025
• Est. primary completion date: June 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	University of Colorado Health	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Urological Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Knowledge	qualitative analysis of interview data	12 months
Secondary	Decisional Quality	assessed via decisional conflict (Decisional Conflict Scale, O'Connor, 1993 updated 2005), http://www.ohri.ca/decisionaid/	12 months
Secondary	Decisional Regret	Decision Regret Scale, O'connor, 1996, University of Ottawa	12 months
Secondary	Value Concordance	a combination of the above decision quality and regret surveys as well as qualitative analysis of interview data	12 months