NCT06674863

Addressing Health Literacy With a Tailored Survivorship Care Plan

Addressing Health Literacy With a Tailored Survivorship Care Plan to Improve Access in Underserved African American Prostate Cancer Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Compare outcomes after patients receive usual care from their providers with a standard SCP and after patients receive tailoring of the SCP with the low literacy educational supplement. II. To quantify the potential benefit of tailoring the care plan and the educational supplement. III. Compare providers' assessment of patients': IIIa. Health literacy; IIIb. Comprehension of survivorship care recommendations; IIIc. Understanding of long term and late effects from treatment; IIId. To measures obtained from patients. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (INTERVENTION): Patients receive standard SCP during a provider visit and a tailored SCP with a low literacy educational supplement during a structured interview over 30-60 minutes. GROUP II (CONTROL): Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes.

Conditions

• Localized Prostate Carcinoma
• Oligometastatic Prostate Carcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Educational Intervention	Receive a low literacy educational supplement
OTHER	Interview	Undergo a structured interview
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Supportive Care	Receive standard SCP
OTHER	Supportive Care	Receive a tailored SCP

Timeline

• Start date: 2025-11-07
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2024-11-05
• Last updated: 2025-12-09

Locations

3 sites across 1 country: United States