NCT06785441

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Timeline

• Start date: 2023-05-25
• Primary completion: 2027-02-02
• Completion: 2030-02-02
• First posted: 2025-01-21
• Last updated: 2025-02-04

Locations

1 site across 1 country: United States