Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05497024

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

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.

Recruiting

Interested in participating?

Request Info

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

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

Who can participate

Healthy volunteers accepted: No

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

Patients

Inclusion criteria

  • Males aged 65 or older
  • Diagnosis of localized prostate cancer
  • On active surveillance for 12 or more months
  • Fluent in English

Exclusion criteria

  • Receiving treatment for another cancer (primary or recurrence)

Caregivers

Inclusion criteria

  • 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

  • None

Clinicians

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Interviews

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

Surveys

Behavioral

Participants may answer questions that are sensitive in nature.

Primary outcomes

  1. 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)

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
2022
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2022
Registry last updated
Apr 16, 2026

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.

Related clinical trials

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