Older Men’s Decision Making About Active Surveillance for Prostate Cancer – Aim 3: Decision Aid Cognitive and Usability Testing
Status
RECRUITING
Phase
Age
≥ 65 Years
Enrollments
45Conditions
Prostate CancerSummary
This protocol describes development and user testing of an educational shared decision making intervention to help men with prostate cancer who are on active surveillance make decisions with their health care providers about if and when to de-escalate surveillance testing. The project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. For these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.
Detailed Description
Objectives:
The overall goal of this protocol is to develop and refine an educational tool for use by patients and health-care providers to help men with localized prostate cancer make informed decisions about discontinuation of active surveillance.
* Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with patients
* Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with care partners/caregivers
* Conduct expert reviews of a prototype decision aid with clinicians
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Lisa Lowenstein, MD
- 713-563-0020
- [email protected]
Principal Investigator
- Lisa Lowenstein, MD
Eligibility Criteria
Patients
Inclusion Criteria:
1. Males aged 65 or older
2. Diagnosis of localized prostate cancer
3. On active surveillance for 12 or more months
4. Fluent in English
Exclusion Criteria:
1. Receiving treatment for another cancer (primary or recurrence)
Caregivers
Inclusion Criteria:
1. Aged 18 or older
2. Fluent in English
3. Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)
Exclusion Criteria:
4. None
Clinicians
Inclusion Criteria:
1. Aged 18 or older
2. Fluent in English
3. Provides clinical care for patients with prostate cancer (e.g. medical oncologists, urologists, radiation oncologists, nurse practitioners, physician assistants)
Exclusion Criteria:
1. None
Study Plan
Surveys
Participants may answer questions that are sensitive in nature.
BEHAVIORAL:
SurveysDescription:
Participants may answer questions that are sensitive in nature.
Interviews
The interview may occur over phone, web conferencing, or in-person.
BEHAVIORAL:
InterviewsDescription:
Participants will discuss background, such as race, education, and living situation.nnParticipants will discuss Prostate cancer Participants will discuss feedback on the educational material
Outcome Measures
Primary Outcome Measures
The Ottawa Acceptability Scale
Timeline
Last Updated
October 15, 2024Start Date
August 11, 2022Today
May 12, 2025Completion Date ( Estimated )
February 2, 2027
Sponsors of this trial
Lead Sponsor
M.D. Anderson Cancer CenterCollaborating Sponsors
American Cancer Society, Inc.
RECRUITING 
≥ 18 Years