Helping African-American men with early prostate cancer understand treatment choices
Improving Health Literacy in African-American Prostate Cancer Patients
This study will test whether a short, scripted low-literacy educational supplement given after a urology visit helps newly diagnosed African-American men with early-stage prostate cancer better understand treatment options and side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 25 Years to 100 Years |
| Sex | Male |
| Sponsor | Emory University Academic / other |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT03322891 on ClinicalTrials.gov |
What this trial studies
This is an observational interview study enrolling newly diagnosed, early-stage (AJCC T1-T2) African-American prostate cancer patients at Emory-affiliated clinics in Atlanta. Participants complete interviews and measures of comprehension and decisional conflict after usual clinician counseling and again after receiving a tailored, scripted low-literacy educational supplement. Investigators will compare patient responses to urologists' assessments of patient literacy, side-effect preferences, decision stage, treatment choice, and preferred role in decision making. The team will analyze changes in comprehension and decisional conflict to quantify how the supplement might improve patient understanding and physician information.
Who should consider this trial
Good fit: Newly diagnosed African-American men with AJCC clinical stage T1-T2 prostate cancer who receive care at the participating Atlanta sites and can complete consent and interviews in English are ideal candidates.
Not a fit: Patients with more advanced disease, significant cognitive impairment, non-English speakers, or those already trained as RNs/MDs are unlikely to benefit from this low-literacy educational approach.
Why it matters
Potential benefit: If successful, the supplement could improve patient understanding of options and side effects, reduce decisional conflict, and support clearer decision conversations with clinicians.
How similar studies have performed: Previous work with decision aids and low-literacy educational materials in prostate and other cancers has shown improved knowledge and reduced decisional conflict in many but not all studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 3 other locations
- Atlanta VA Medical Center — Atlanta, Georgia, United States (Recruiting)
- Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Kerry Kilbridge, MD — Dana-Farber Cancer Institute
- Study coordinator: Viraj Master, MD
- Email: vmaster@emory.edu
- Phone: 404-778-4898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.