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

NCT06785441 | Recruiting

• 1 other identifier: 2023-0128
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Preparation for Decision Making Scale

  The Preparation for Decision Making Scale (PrepDM)19 is a validated scale that assesses whether the decision aid helped prepare a patient to talk with their clinician in making a treatment decision. The scale has 10 items with a 5-point Likert response format, Score Scale 1 (not at all) and 5 (a great deal).

  Through study completion and average of 1 year

Eligibility Criteria

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

Study Population

Male

You may qualify if:

• Patients:
• Males aged 65 or older
• Diagnosis of localized prostate cancer
• Have not received curative intent treatment for their prostate cancer
• Fluent in English
• Care partners/caregivers:
• Aged 18 or older
• Fluent in English
• Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)

You may not qualify if:

• Patients
• \. Currently receiving treatment for another cancer (primary or recurrence)
• Care partners/caregivers
• \. 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

• M.D. Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

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: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 21, 2025
• Study Start: May 25, 2023
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2030
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

US (1)