Tailored survivorship care plans to improve health literacy after prostate cancer
Addressing Health Literacy With a Tailored Survivorship Care Plan to Improve Access in Underserved African American Prostate Cancer Patients
This will test whether a survivorship care plan designed for people with low health literacy helps Black or African American men who finished treatment for localized or oligometastatic prostate cancer better understand and access follow-up care than a standard plan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT06674863 on ClinicalTrials.gov |
What this trial studies
This randomized study assigns eligible Black or African American men 1–4 years after primary surgery and/or radiation for localized or oligometastatic prostate cancer to receive either a standard survivorship care plan (SCP) or a tailored SCP plus a low-literacy educational supplement during a structured interview. Outcomes include patient-reported comprehension of survivorship recommendations, understanding of long-term and late treatment effects, and comparisons with provider assessments of patient health literacy. Participants complete standardized questionnaires and interviews over a 30–60 minute visit to measure differences between groups. The trial is conducted at Emory-affiliated sites in Atlanta and requires English proficiency and capacity to consent.
Who should consider this trial
Good fit: Black or African American men who are disease-free 1–4 years after primary surgery and/or radiation for localized or oligometastatic prostate cancer, who can understand English and provide informed consent (patients on adjuvant non-palliative androgen deprivation therapy are eligible).
Not a fit: Patients with recurrent prostate cancer, active second malignancies requiring treatment, dementia or significant cognitive impairment, or who cannot clearly understand English are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the tailored SCP could improve patient understanding of follow-up care, increase engagement with recommended monitoring, and help reduce survivorship care disparities.
How similar studies have performed: Previous work using low-literacy educational materials and tailored survivorship communication has shown modest improvements in patient knowledge and self-management, but few trials have specifically targeted Black or African American prostate cancer survivors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. (Race/ethnicity per medical records and self report) * Patients who are still receiving adjuvant androgen deprivation therapy following primary radiation with non-palliative intent may be included Exclusion Criteria: * Dementia or cognitive impairment per provider clinical assessment * Unable to give informed consent in the judgement of the patient's oncology provider * Recurrent prostate cancer after primary treatment * Less than 18 years of age at the time of informed consent * Diagnosis of active second malignancy requiring treatment * Individuals who are not able to clearly understand English since the outcome measures require understanding of English
Where this trial is running
Atlanta, Georgia and 2 other locations
- Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- Atlanta VA Medical Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Viraj Master, MD, PhD, FACS — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Kerry L. Kilbridge, MD, MSc
- Email: Kerry_Kilbridge@DFCI.HARVARD.EDU
- Phone: 617-632-2429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.