Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT03322891

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Educational Supplement

Standard Practice Education

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT03322891

Start date

Jul 21, 2016

Status verified date

Jan, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 25 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

210 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Educational Supplement

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

Interventions

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Viraj Master, MD

404-778-4898vmaster@emory.edu

Locations

Atlanta VA Medical Center

Recruiting

Atlanta, Georgia, United States, 30033

Contacts

Mohammad Hajiha, MD

404-778-4898mhajiha@emory.edu

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Viraj Master, MD

404-778-4898vmaster@emory.edu

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Viraj Master, MD

404-778-4898vmaster@emory.edu

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Viraj Master, MD

404-778-4898vmaster@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • Urology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-29.