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

NCT05497024 | Recruiting

• 2 other identifiers: 2022-0375NCI-2022-06569
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The Ottawa Acceptability Scale

  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

Study Arms (2)

Surveys

Participants may answer questions that are sensitive in nature.

Behavioral: Surveys

Interviews

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

Behavioral: Interviews

Interventions

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

Interviews

Surveys BEHAVIORAL

Participants may answer questions that are sensitive in nature.

Surveys

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

M D Anderson Cancer Center

You may qualify if:

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

You may not qualify if:

• \. Receiving treatment for another cancer (primary or recurrence)
• Caregivers
• Aged 18 or older
• Fluent in English
• Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)
• None
• Clinicians
• 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)
• \. None

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Interviews as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lisa Lowenstein, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Lowenstein, MD

CONTACT

713-563-0020; deescalatepca@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 11, 2022
• Study Start: August 15, 2022
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)