Improving Health Literacy in African-American Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

Improving Health Literacy in African-American Prostate Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322891
• Other study ID #: IRB00091879
• Status: Completed
• Phase: N/A
• Start date: July 21, 2016
• Est. completion date: January 17, 2019

Study information

• Verified date: June 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 17, 2019
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• Standard Practice Education
Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Atlanta	Georgia
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Decisional Conflict Scale Score	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).	Baseline, Post-Intervention (Up to 6 Weeks)
Primary	Change in Comprehension of Treatment Options Score assessed by Interview	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.	Baseline, Post-Intervention (Up to 6 Weeks)
Primary	Change in Comprehension of Side Effects Score assessed by Interview	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.	Baseline, Post-Intervention (Up to 6 Weeks)
Secondary	Rapid Estimate of Adult Literacy in Medicine (REALM) Score	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	Baseline
Secondary	Change in the Stage of Decision Making Scale Score	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).	Baseline, Post-Intervention (Up to 6 Weeks)