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

NCT ID: NCT06674863Sponsor: Emory UniversityLast updated: 2025-12-09

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.

Arms & interventions

  • OtherEducational Intervention

    Receive a low literacy educational supplement

  • OtherInterview

    Undergo a structured interview

  • OtherQuestionnaire Administration

    Ancillary studies

  • OtherSupportive Care

    Receive standard SCP

  • OtherSupportive Care

    Receive a tailored SCP

Outcome measures

Primary

  • Comprehension of survivorship care recommendations and prostate specific antigen surveillance

    Comprehension will be scored as dichotomous variables, correct or incorrect. The proportion of patients who correctly understand after the standard survivorship care plan (SCP) compared to the proportion who correctly understand after the standard SCP + tailoring + educational support will be analyzed using a two-tailed Z-score test for equality of two proportions at a significance level of P \< 0.05.

    Time frame: At baseline and up to 3 month phone call

  • Comprehension of treatment side effects and late effects

    Comprehension will be scored as dichotomous variables, correct or incorrect. The proportion of patients who correctly understand after the standard SCP compared to the proportion who correctly understand after the standard SCP + tailoring + educational support will be analyzed using a two-tailed Z-score test for equality of two proportions at a significance level of P \< 0.05.

    Time frame: At baseline and up to 3 month phone call

Secondary

  • Access to survivorship care for late and long-term side effects

    Time frame: At baseline and up to 3 month phone call

  • Decision regret

    Time frame: At baseline and up to 3 month phone call

  • Change in decisional conflict

    Time frame: At baseline and up to 3 month phone call

  • Preparedness for survivorship

    Time frame: At baseline and up to 3 month phone call

  • Patient self-efficacy

    Time frame: At baseline and up to 3 month phone call

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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

Study locations (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303

Recruiting
Sierra Williams · Contact
Viraj Master, MD, PhD, FACS · Principal Investigator

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Recruiting
Sierra Williams · Contact
Viraj Master, MD, PhD, FACS · Principal Investigator

Atlanta VA Medical Center

Atlanta, Georgia, 30329

Recruiting
Sierra Williams · Contact
Viraj Master, MD, PhD, FACS · Principal Investigator