Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interviews, Surveys.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Behavioral Interviews
Participants will discuss background, such as race, education, and living situation. Participants will discuss Prostate cancer Participants will discuss feedback on the educational material - Behavioral Surveys
Participants may answer questions that are sensitive in nature.
Primary outcome measures
- The Ottawa Acceptability Scale [Time frame: through study completion and average of 1 year]
Eligibility criteria
Patients
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)
Caregivers
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
- None
Clinicians
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
1\. None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05497024 · 2022-0375 · NCI-2022-06569