Actively Recruiting
Addressing Health Literacy With a Tailored Survivorship Care Plan to Improve Access in Underserved African American Prostate Cancer Patients
Led by Emory University · Updated on 2025-12-09
150
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how a tailored survivorship care plan (SCP) affects understanding and access to survivorship care in Black or African American men with localized or oligometastatic prostate cancer. This study compares a standard SCP, based on American Society of Clinical Oncology guidelines, with a tailored SCP that includes a low literacy educational supplement. The goal is to address health literacy barriers that may impact patients' ability to understand treatment options, side effects, and long-term health management. Participants are randomly assigned to one of two groups. One group receives the standard SCP during a provider visit and the tailored SCP with the low literacy supplement during a structured 30-60 minute interview. The other group receives only the standard SCP during a provider visit followed by a structured interview of similar duration. Both groups complete questionnaires and interviews to assess their understanding and use of survivorship care. During the study, participants' comprehension of survivorship care recommendations, prostate-specific antigen surveillance, and treatment side effects will be measured at baseline and during a follow-up phone call up to 3 months later. The study also evaluates access to survivorship care, decision regret, decisional conflict, preparedness for survivorship, and patient self-efficacy. The total study duration includes initial visits and follow-up assessments, with safety monitoring and no blinding involved.
CONDITIONS
Brief Title
Addressing Health Literacy With a Tailored Survivorship Care Plan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Black and African American men who are disease-free after completing primary surgery and/or radiation treatment for localized or oligometastatic prostate cancer between 1 to 4 years prior to enrollment
- Patients still receiving adjuvant androgen deprivation therapy following primary radiation with non-palliative intent may be included
- Able to understand and communicate in English
- At least 18 years of age at the time of informed consent
You will not qualify if you...
- Dementia or cognitive impairment as assessed by provider
- Unable to give informed consent as judged by oncology provider
- Recurrent prostate cancer after primary treatment
- Younger than 18 years of age at consent
- Diagnosis of active second malignancy requiring treatment
- Unable to clearly understand English due to language barriers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single visit
Participants receive a standard survivorship care plan during a provider visit. In the experimental group, participants also receive a tailored survivorship care plan with a low literacy educational supplement during a structured interview lasting 30-60 minutes. In the control group, participants receive the standard survivorship care plan and undergo a structured interview lasting 30-60 minutes.
1 to 2 visits (in-person) depending on group assignment
Duration - Up to 3 months
Participants are followed up to assess comprehension of survivorship care recommendations, treatment side effects, access to survivorship care, decision regret, decisional conflict, preparedness for survivorship, and self-efficacy.
1 phone call follow-up visit
Trial Site Locations
Total: 3 locations
1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
K
Kerry L. Kilbridge, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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