Improving Health Literacy in African-American Prostate Cancer Patients

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Educational Supplement; Other: Standard Practice Education

• Registration Number: NCT03322891
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2016-07-21
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Primary Completion: 2018-12-18
• Study Completion: 2019-01-17
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Educational Supplement	Standard Practice Education	Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.
Educational Supplement	Educational Supplement	Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.

Primary Outcome Measures

Name	Time	Method
Change in Decisional Conflict Scale Score	Baseline, Post-Intervention (Up to 6 Weeks)	The decisional conflict scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Change in Comprehension of Treatment Options Score assessed by Interview	Baseline, Post-Intervention (Up to 6 Weeks)	Comprehension of treatment options will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand treatment after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
Change in Comprehension of Side Effects Score assessed by Interview	Baseline, Post-Intervention (Up to 6 Weeks)	Comprehension of side effects will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand side effects after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.

Secondary Outcome Measures

Name	Time	Method
Rapid Estimate of Adult Literacy in Medicine (REALM) Score	Baseline	The REALM is a screening instrument to assess an adult patient's ability to read common medical words and lay terms for body parts and illnesses. Scores are assessed on an education grade equivalent; 0-18 = 3rd Grade and Below Will not be able to read most low literacy materials; will need repeated oral instructions, materials composed primarily of illustrations, or audio or video tapes; 19-44 = 4th to 6th Grade Will need low literacy materials; may not be able to read prescription labels; 45-60 = 7th to 8th Grade Will struggle with most patient education materials; 61-66 = High School Will be able to read most patient education materials
Change in the Stage of Decision Making Scale Score	Baseline, Post-Intervention (Up to 6 Weeks)	Stage of decision making refers to individual's readiness to engage in decision making, progress in making a choice, and receptivity to considering or re-considering options. This tool is not scored. However, the categories can be used to determine co-variation in decisional conflict (tends to be higher in earlier stages) and success of interventions (success higher among those in active deliberation stage).

Trial Locations

Locations (4)

Atlanta VA Medical Center; 🇺🇸 Atlanta, Georgia, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States