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

April 13, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Lisa Lowenstein, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

M D Anderson Cancer Center

Description

Patients

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

Exclusion Criteria:

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

Caregivers

Inclusion Criteria:

  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:

  4. None

Clinicians

Inclusion Criteria:

  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. None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surveys
Participants may answer questions that are sensitive in nature.
Behavioral: Surveys
Participants may answer questions that are sensitive in nature.
Interviews
The interview may occur over phone, web conferencing, or in-person.
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Ottawa Acceptability Scale
Time Frame: through study completion and average of 1 year

The Ottawa Acceptability scale includes 10 items to assess participant's rating of the educational material ease of use, clarity of information, length, level of detail provided, ability to hold one's interest, and satisfaction with how the materials prepared them for discussing the decision with their clinician

Score Scale (Strongly agree, Agree, Neither agree nor disagree, Disagree Strongly disagree) and (Not at all, A little, Somewhat, Quite a bit, A great deal)
through study completion and average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Lisa Lowenstein, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0375
  • NCI-2022-06569 (Other Identifier: Clinical Trials Reporting Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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