Improving Health Literacy in African-American Prostate Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational Supplement, Standard Practice Education.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 25 years — 100 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Educational Supplement
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. - Other Standard Practice Education
Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.
Primary outcome measures
- Change in Decisional Conflict Scale Score [Time frame: Baseline, Post-Intervention (Up to 6 Weeks)]
- Change in Comprehension of Treatment Options Score assessed by Interview [Time frame: Baseline, Post-Intervention (Up to 6 Weeks)]
- Change in Comprehension of Side Effects Score assessed by Interview [Time frame: Baseline, Post-Intervention (Up to 6 Weeks)]
Secondary outcome measures (2)
- Rapid Estimate of Adult Literacy in Medicine (REALM) Score [Time frame: Baseline]
- Change in the Stage of Decision Making Scale Score [Time frame: Baseline, Post-Intervention (Up to 6 Weeks)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 4 centers
- Atlanta VA Medical Center — Atlanta
- Grady Memorial Hospital — Atlanta
- Emory University — Atlanta
- Emory Saint Joseph's Hospital — Atlanta
Identifiers
NCT: NCT03322891 · IRB00091879