Recruiting

NCT Number: NCT06785441

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

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

65 year and older

Sex eligibility

Male

Study type

Observational

Primary location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Lisa Lowenstein, MD

CONTACT

[email protected]

713-563-0020

Lisa Lowenstein, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

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

Care partners/caregivers:

Aged 18 or older
Fluent in English
Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)

Exclusion criteria

Patients

Currently receiving treatment for another cancer (primary or recurrence)

Care partners/caregivers

None

Treatment and study plan

Primary outcomes

Preparation for Decision Making Scale

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Lowenstein, MD

CONTACT

[email protected]

713-563-0020

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

American Cancer Society, Inc.

Registry information

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2030
First posted: Jan 21, 2025
Registry last updated: Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting