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

Last updated: October 11, 2024
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Urologic Cancer

Treatment

Interviews

Surveys

Clinical Study ID

NCT05497024
2022-0375
NCI-2022-06569
  • Ages > 65
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

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, familymember, 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 Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Interviews
Phase:
Study Start date:
August 15, 2022
Estimated Completion Date:
February 02, 2027

Study 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

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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