Educational Interview in Improving Health Literacy in African-American Participants with Prostate Cancer
This clinical trial studies how well an educational interview works in improving health literacy in African-American participants with prostate cancer. An educational interview may help participants understand prostate cancer treatment and side effects better.
Inclusion Criteria
- Black men and patients of African descent considering primary treatment for long term disease control (non-palliative intent) of their prostate cancer at Atlanta Veterans Affairs (VA) Medical Center, Emory University and Grady Memorial Hospital. This may include patients with oligometastatic disease and involved lymph nodes that can be treated with non-palliative intent. Radiographic staging may be used but is not required.
Exclusion Criteria
- Non Black patients.
- History of dementia.
- History of cognitive impairment.
- Unable to undergo the informed consent process in English or participate in the group session or interview per the judgment of the primary oncology provider.
- Patients with widely metastatic prostate cancer and patients with small cell cancer of the prostate are excluded.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03322891.
Locations matching your search criteria
United States
Georgia
Atlanta
Decatur
PRIMARY OBJECTIVES:
I. Characterize health literacy in a group of newly diagnosed, early stage, African American prostate cancer patients across five empirical domains including 1) reading skills, 2) simple mathematical skills for risk communication (the ability to calculate a simple fraction or a percent), 3) anatomic knowledge, 4) comprehension of common medical terms used in prostate cancer. (group session)
II. Assess comprehension of prostate cancer treatment options and side effects in this group of patients after they meet with their provider to discuss their treatment alternatives (standard practice). (group session)
III. Deliver a low literacy educational supplement that explicitly addresses each domain of health literacy to tailor content and augment the information that patients receive from their urologists. (group session)
IV. Compare outcomes after patients meet with their urologist and after receiving the low literacy supplement to quantify the potential benefit of a targeted health literacy supplement over and above standard practice. (group session)
V. Compare urologists’ assessment of patients’ 1) health literacy 2) preferences for side effects to measures obtained from patients. (group session)
VI. Improve patients’ comprehension of treatment options and side effects through shared vocabulary for genitourinary (GU) function. (nested cohort)
VII. Improve shared decision making by decreasing decisional conflict among patients. (nested cohort)
VIII. Facilitate provider’s insights into the patient’s 1) preferred terms for urinary, bowel and sexual function; 2) preferred role in decision making; 3) values and preferences; to support shared decision making. (nested cohort)
OUTLINE:
GROUP SESSION: Patients attend a face to face interview over 90 minutes consisting of a scripted educational supplement regarding prostate cancer treatment options and side effects on study.
NESTED COHORT: Patients attend a a one-time, structured interview over 60 minutes and a single follow up phone call over 5 minutes on study.
After completion of study, patients are followed up prior to prostate cancer treatment.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorMohammad Hajiha
- Primary IDHU-HEALTHLITERACY
- Secondary IDsNCI-2018-00842, IRB00085616, IRB00091879
- ClinicalTrials.gov IDNCT03322891