Improving Health Literacy in African-American Prostate Cancer Patients

Clinicaltrials.gov ID: NCT03322891
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age 25 - 100 Years
b-bullseye-arrow Enrollments 150

Conditions

Prostate Cancer

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.

Locations

4 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Kerry Kilbridge, MD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Kerry Kilbridge, MD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Kerry Kilbridge, MD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Kerry Kilbridge, MD

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

Study Plan

Educational Supplement

EXPERIMENTAL

Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.

  • OTHER:

    Educational Supplement

    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.
  • OTHER:

    Standard Practice Education

    Description:

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

Outcome Measures

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

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)

Timeline

  • Last Updated
    September 2, 2025
  • Start Date
    October 26, 2017
  • Today
    December 26, 2025
  • Completion Date ( Estimated )
    March 31, 2027

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