NCT06674863 Addressing Health Literacy With a Tailored Survivorship Care Plan
| NCT ID | NCT06674863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Localized Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-11-07 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial compares the impact of a tailored survivorship care plan (SCP) to a standard SCP on the understanding of and access to survivorship care in black or African American patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread from where it first started (primary site) to a limited number of places in the body (oligometastatic). SCPs summarize treatment history and recommendations for monitoring and maintaining health, and may also include potential long term effects of treatments received. The intention of a SCP is to help patients participate in their own health care. However, many patients have below basic levels of health literacy, meaning, they have a lower ability to obtain, communicate, process and understand basic health information and services to make health decisions. In fact, poor health literacy has been linked with worse quality of life in prostate cancer survivors. A tailored SCP includes the addition of an educational supplement based on lower reading and writing skills (low literacy) and may address health literacy barriers to understanding of treatment options and side effects. A standard SCP uses a template based on the American Society of Clinical Oncology (ASCO) guidelines for prostate cancer. A tailored SCP with low literacy educational supplements may be more effective compared to a standard SCP in improving understanding and access to survivorship care in black or African American patients with localized or oligometastatic prostate cancer.
Eligibility 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
Contact & Investigator
Viraj Master, MD, PhD, FACS
PRINCIPAL INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Frequently Asked Questions
Who can join the NCT06674863 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Localized Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06674863 currently recruiting?
Yes, NCT06674863 is actively recruiting participants. Contact the research team at Kerry_Kilbridge@DFCI.HARVARD.EDU for enrollment information.
Where is the NCT06674863 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT06674863 clinical trial?
NCT06674863 is sponsored by Emory University. The principal investigator is Viraj Master, MD, PhD, FACS at Emory University Hospital/Winship Cancer Institute. The trial plans to enroll 150 participants.