Clinical trial NCT03322891: Improving Health Literacy in African-American Prostate Cancer Patients
Official title: Improving Health Literacy in African-American Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Urology
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2017-10-26
Enrollment: 160
Sex: MALE
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Decisional Conflict Scale Score
timeFrame: Baseline, Post-Intervention (Up to 6 Weeks)
measure: Change in Comprehension of Treatment Options Score assessed by Interview
timeFrame: Baseline, Post-Intervention (Up to 6 Weeks)
measure: Change in Comprehension of Side Effects Score assessed by Interview
timeFrame: Baseline, Post-Intervention (Up to 6 Weeks)
Secondary outcomes:
measure: Rapid Estimate of Adult Literacy in Medicine (REALM) Score
timeFrame: Baseline
measure: Change in the Stage of Decision Making Scale Score
timeFrame: Baseline, Post-Intervention (Up to 6 Weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Kerry Kilbridge, MD
role: PRINCIPAL_INVESTIGATOR
References: