Improving Health Literacy in African-American Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Supplement
Standard Practice Education
Sponsored by

About this trial
This is an interventional other trial for Prostate Cancer focused on measuring Urology
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
Sites / Locations
- Atlanta VA Medical Center
- Grady Memorial Hospital
- Emory University
- Emory Saint Joseph's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Educational Supplement
Arm Description
Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.
Outcomes
Primary Outcome Measures
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).
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.
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.
Secondary Outcome Measures
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
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).
Full Information
NCT ID
NCT03322891
First Posted
October 23, 2017
Last Updated
June 15, 2020
Sponsor
Emory University
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT03322891
Brief Title
Improving Health Literacy in African-American Prostate Cancer Patients
Official Title
Improving Health Literacy in African-American Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 21, 2016 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
January 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Urology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational Supplement
Arm Type
Experimental
Arm Description
Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.
Intervention Type
Other
Intervention Name(s)
Educational Supplement
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Practice Education
Intervention Description
Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.
Primary Outcome Measure Information:
Title
Change in Decisional Conflict Scale Score
Description
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).
Time Frame
Baseline, Post-Intervention (Up to 6 Weeks)
Title
Change in Comprehension of Treatment Options Score assessed by Interview
Description
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.
Time Frame
Baseline, Post-Intervention (Up to 6 Weeks)
Title
Change in Comprehension of Side Effects Score assessed by Interview
Description
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.
Time Frame
Baseline, Post-Intervention (Up to 6 Weeks)
Secondary Outcome Measure Information:
Title
Rapid Estimate of Adult Literacy in Medicine (REALM) Score
Description
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
Time Frame
Baseline
Title
Change in the Stage of Decision Making Scale Score
Description
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).
Time Frame
Baseline, Post-Intervention (Up to 6 Weeks)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Kilbridge, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Improving Health Literacy in African-American Prostate Cancer Patients
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