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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06785441

Enrollment

180

Registered

2025-01-21

Start date

2023-05-25

Completion date

2030-02-02

Last updated

2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

MALE

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Contacts

Primary ContactLisa Lowenstein, MD

deescalatepca@mdanderson.org713-563-0020

Outcome results