Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- The Ottawa Acceptability Scale
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria:
- •Males aged 65 or older
- •Diagnosis of localized prostate cancer
- •On active surveillance for 12 or more months
- •Fluent in English
Exclusion Criteria
- •1. Receiving treatment for another cancer (primary or recurrence)
- •Inclusion Criteria:
- •Aged 18 or older
- •Fluent in English
- •Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)
- •Exclusion Criteria:
- •Inclusion Criteria:
- •Aged 18 or older
- •Fluent in English
- •Provides clinical care for patients with prostate cancer (e.g. medical oncologists, urologists, radiation oncologists, nurse practitioners, physician assistants)
- •Exclusion Criteria:
Arms & Interventions
Surveys
Participants may answer questions that are sensitive in nature.
Intervention: Surveys (Behavioral)
Interviews
The interview may occur over phone, web conferencing, or in-person.
Intervention: Interviews (Behavioral)
Outcomes
Primary Outcomes
The Ottawa Acceptability Scale
Time Frame: through study completion and average of 1 year
The Ottawa Acceptability scale includes 10 items to assess participant's rating of the educational material ease of use, clarity of information, length, level of detail provided, ability to hold one's interest, and satisfaction with how the materials prepared them for discussing the decision with their clinician Score Scale (Strongly agree, Agree, Neither agree nor disagree, Disagree Strongly disagree) and (Not at all, A little, Somewhat, Quite a bit, A great deal)
Secondary Outcomes
No secondary outcomes reported