Addressing Health Literacy With a Tailored Survivorship Care Plan

Official title

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

Overview

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.

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

Primary outcome measures

• Comprehension of survivorship care recommendations and prostate specific antigen surveillance [Time frame: At baseline and up to 3 month phone call]
• Comprehension of treatment side effects and late effects [Time frame: At baseline and up to 3 month phone call]

Secondary outcome measures (5)

• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 3 centers

• Grady Memorial Hospital — Atlanta
• Emory University Hospital/Winship Cancer Institute — Atlanta
• Atlanta VA Medical Center — Atlanta

Identifiers

NCT: NCT06674863 · STUDY00008365 · NCI-2024-08650 · STUDY00008365 · WINSHIP6368-24 · P30CA138292

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗