Improving Health Literacy in African-American Prostate Cancer Patients

NCT ID: NCT03322891

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-21
• Study Completion Date: 2027-03-31

Brief Summary

Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.

Detailed Description

Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.

Investigators hypothesize that the delivery of a scripted, tailored, low literacy educational supplement will result in a statistically significant decrease in decisional conflict, and a statistically significant improvement in comprehension of cancer treatment and its side effects compared to standard practice.

The study team will measure patients' comprehension of treatment options and side effects, as well as decisional conflict; after standard practice, and again after exposure to the educational supplement. Investigators will compare the urologists' assessment of patients' 1) health literacy 2) preferences for side effects 3) stage of decision making, 4) treatment choice or predisposition toward treatment choice. 5) preference for role in decision making (active, passive, or shared with physician); to measures obtained from patients. These comparisons will allow investigators to quantify the potential benefit to the physician of information obtained through the interview and low literacy educational supplement.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Educational Supplement

Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.

Group Type: EXPERIMENTAL

Educational Supplement

Intervention Type: OTHER

Participants will receive education about prostate cancer and treatments using models and props during a face-to-face interview. During the interview, participants will also be asked about medical terms and treatments regarding prostate cancer. The interview will last 45 to 60 minutes.

Standard Practice Education

Intervention Type: OTHER

Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.

Interventions

Educational Supplement

Participants will receive education about prostate cancer and treatments using models and props during a face-to-face interview. During the interview, participants will also be asked about medical terms and treatments regarding prostate cancer. The interview will last 45 to 60 minutes.

Intervention Type: OTHER

Standard Practice Education

Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who have undergone pathology review of their prostate biopsy at Emory University, Grady Memorial Hospital, Saint Joseph's Hospital, and Atlanta VA Medical Center with AJCC clinical stage T1-T2 prostate cancer by physical exam

Exclusion Criteria

• RN or MD degree
• History of head injury or dementia
• History of cognitive impairment
• Unable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist or urological provider

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Viraj Master

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerry Kilbridge, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Atlanta VA Medical Center

Atlanta, Georgia, United States

Site Status: RECRUITING

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Viraj Master, MD

Role: CONTACT

vmaster@emory.edu

404-778-4898

Facility Contacts

Mohammad Hajiha, MD

Role: primary

mhajiha@emory.edu

404-778-4898

Viraj Master, MD

Role: primary

vmaster@emory.edu

404-778-4898

Viraj Master, MD

Role: primary

vmaster@emory.edu

404-778-4898

Viraj Master, MD

Role: primary

vmaster@emory.edu

404-778-4898

Other Identifiers

IRB00091879

Identifier Type: -

Identifier Source: org_study_id