Improving Health Literacy in African-American Prostate Cancer Patients

Emory University

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: Educational Supplement; Other: Standard Practice Education

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03322891

IRB00091879

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: Male

Ages: 25 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

Educational Supplement

Experimental group

Description:

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

Treatment:

Other: Standard Practice Education

Other: Educational Supplement