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Improving Health Literacy in African-American Prostate Cancer Patients

NCT03322891 · Emory University
In plain English

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About this study
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.
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
Study design
Enrollment target: 210 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2016-07-21
Estimated completion: 2027-03-31
Last updated: 2026-01-29
Interventions
Other: Educational SupplementOther: Standard Practice Education
Primary outcomes
  • Change in Decisional Conflict Scale Score (Baseline, Post-Intervention (Up to 6 Weeks))
  • Change in Comprehension of Treatment Options Score assessed by Interview (Baseline, Post-Intervention (Up to 6 Weeks))
  • Change in Comprehension of Side Effects Score assessed by Interview (Baseline, Post-Intervention (Up to 6 Weeks))
Sponsor
Emory University · other
With: United States Department of Defense
Contacts & investigators
ContactViraj Master, MD · contact · vmaster@emory.edu · 404-778-4898
InvestigatorKerry Kilbridge, MD · principal_investigator, Dana-Farber Cancer Institute
All locations (4)
Atlanta VA Medical CenterRecruiting
Atlanta, Georgia, United States
Grady Memorial HospitalRecruiting
Atlanta, Georgia, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
Emory Saint Joseph's HospitalRecruiting
Atlanta, Georgia, United States
Improving Health Literacy in African-American Prostate Cancer Patients · TrialPath