Addressing Health Literacy With a Tailored Survivorship Care Plan

NCT06674863 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-09

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • United States Department of Defense

    collaborator FED
  • Emory University

    lead OTHER

Principal Investigators

  • Viraj Master, MD, PhD, FACS · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06674863 on ClinicalTrials.gov