Improving Health Literacy in African-American Prostate Cancer Patients

NCT03322891 | Recruiting

• 1 other identifier: IRB00091879
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer

Keywords

Urology

Outcome Measures

Primary Outcomes (3)

• Change in Decisional Conflict Scale Score

  The decisional conflict scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).

  Baseline, Post-Intervention (Up to 6 Weeks)

• Change in Comprehension of Treatment Options Score assessed by Interview

  Comprehension of treatment options will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand treatment after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.

  Baseline, Post-Intervention (Up to 6 Weeks)

• Change in Comprehension of Side Effects Score assessed by Interview

  Comprehension of side effects will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand side effects after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.

  Baseline, Post-Intervention (Up to 6 Weeks)

Secondary Outcomes (2)

• Rapid Estimate of Adult Literacy in Medicine (REALM) Score

  Baseline

• Change in the Stage of Decision Making Scale Score

  Baseline, Post-Intervention (Up to 6 Weeks)

Study Arms (1)

Educational Supplement

EXPERIMENTAL

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

Other: Educational Supplement; Other: Standard Practice Education

Interventions

Educational Supplement 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.

Educational Supplement

Standard Practice Education OTHER

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

Educational Supplement

Eligibility Criteria

• Age: 25 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• United States Department of Defense: collaborator

Study Sites (4)

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

RECRUITING

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

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

• Kerry Kilbridge, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viraj Master, MD

CONTACT

404-778-4898; vmaster@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 26, 2017
• Study Start: July 21, 2016
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (4)