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

NCT ID: NCT05497024

Last Updated: 2025-10-27

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

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-15

Study Completion Date

2027-02-02

Brief Summary

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This protocol describes development and user testing of an educational shared decision making intervention to help men with prostate cancer who are on active surveillance 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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Objectives:

The overall goal of this protocol is to develop and refine 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.

* Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with patients
* Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with care partners/caregivers
* Conduct expert reviews of a prototype decision aid with clinicians

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Surveys

Participants may answer questions that are sensitive in nature.

Surveys

Intervention Type BEHAVIORAL

Participants may answer questions that are sensitive in nature.

Interviews

The interview may occur over phone, web conferencing, or in-person.

Interviews

Intervention Type BEHAVIORAL

Participants will discuss background, such as race, education, and living situation.

Participants will discuss Prostate cancer Participants will discuss feedback on the educational material

Interventions

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Interviews

Participants will discuss background, such as race, education, and living situation.

Participants will discuss Prostate cancer Participants will discuss feedback on the educational material

Intervention Type BEHAVIORAL

Surveys

Participants may answer questions that are sensitive in nature.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Males aged 65 or older
2. Diagnosis of localized prostate cancer
3. On active surveillance for 12 or more months
4. Fluent in English


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)


1. Aged 18 or older
2. Fluent in English
3. Provides clinical care for patients with prostate cancer (e.g. medical oncologists, urologists, radiation oncologists, nurse practitioners, physician assistants)

Exclusion Criteria

1\. Receiving treatment for another cancer (primary or recurrence)

Caregivers

4. None

Clinicians


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

MD Anderson Cancer Center

Other Identifiers

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NCI-2022-06569

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0375

Identifier Type: -

Identifier Source: org_study_id

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