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

Clinicaltrials.gov ID: NCT06785441
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 65 Years
b-bullseye-arrow Enrollments 180

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Lisa Lowenstein, MD

Eligibility Criteria

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

Outcome Measures

Primary Outcome Measures

Preparation for Decision Making Scale

Time Frame: Through study completion and average of 1 year

Timeline

  • Last Updated
    February 4, 2025
  • Start Date
    January 21, 2025
  • Today
    May 11, 2025
  • Completion Date ( Estimated )
    February 2, 2030

Similar Trials

light-list-check RECRUITING light-blue-people ≥ 18 Years
light-list-check RECRUITING light-blue-people ≥ 18 Years
light-list-check RECRUITING light-blue-people All Ages