Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Behavioral: Surveys; Behavioral: Interviews

Study type: Observational

Funder types: Other

Identifiers

NCT05497024

NCI-2022-06569 (Other Identifier)

2022-0375

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 estimated patients

Sex: Male

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

45 participants in 2 patient groups

Surveys

Description:

Participants may answer questions that are sensitive in nature.

Treatment:

Behavioral: Surveys

Interviews

Description:

The interview may occur over phone, web conferencing, or in-person.

Treatment:

Behavioral: Interviews