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

NCT ID: NCT06785441

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-25

Study Completion Date

2030-02-02

Brief Summary

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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

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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

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Prostate Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Lowenstein, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lisa Lowenstein, MD

Role: CONTACT

713-563-0020

Facility Contacts

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Lisa Lowenstein, MD

Role: primary

713-563-0020

Related Links

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http://www.mdanderson.org

M.D. Anderson Cancer Center

Other Identifiers

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2023-0128

Identifier Type: -

Identifier Source: org_study_id

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