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

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06785441
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This protocol describes pilot testing of an educational shared decision-making intervention to help men with localized prostate cancer 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

Primary Objective:

The overall goal of this protocol is to test initial efficacy of three versions of 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. A pre-post design was selected to provide initial efficacy data of the different versions of the shared decision-making intervention. Thereby, providing preliminary data in preparation for a follow-up comparative study.

Study Timeline

• Study Start: 2023-05-25
• Status Verified: 2025-01
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-21
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2027-02-02
• Study Completion: 2030-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

Patients:

1. Males aged 65 or older
2. Diagnosis of localized prostate cancer
3. Have not received curative intent treatment for their prostate cancer
4. Fluent in English

Care partners/caregivers:

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

Patients

1. Currently receiving treatment for another cancer (primary or recurrence)

Care partners/caregivers

1. None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preparation for Decision Making Scale	Through study completion and average of 1 year	The Preparation for Decision Making Scale (PrepDM)19 is a validated scale that assesses whether the decision aid helped prepare a patient to talk with their clinician in making a treatment decision. The scale has 10 items with a 5-point Likert response format,; Score Scale 1 (not at all) and 5 (a great deal).

Trial Locations

Locations (1)

M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States