Addressing Health Literacy With a Tailored Survivorship Care Plan

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06674863
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Group I (standard SCP, tailored SCP)
    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.
  • Active Comparator: Group II (standard SCP)
    Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes.

Primary Outcome Measure

Comprehension of survivorship care recommendations and prostate specific antigen surveillance [ Time Frame: At baseline and up to 3 month phone call ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical CenterAtlantaGeorgia30329
Sierra Williams
[email protected]
4047784729
Viraj Master, MD, PhD, FACS (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Sierra Williams
[email protected]
404-778-4898
Viraj Master, MD, PhD, FACS (PRINCIPAL_INVESTIGATOR)
Grady Memorial HospitalAtlantaGeorgia30303
Sierra Williams
[email protected]
404-778-4729
Viraj Master, MD, PhD, FACS (PRINCIPAL_INVESTIGATOR)

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