Addressing Health Literacy With a Tailored Survivorship Care Plan

NCT ID: NCT06674863

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-07
• Study Completion Date: 2030-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: OTHER

Receive a low literacy educational supplement

Interview

Intervention Type: OTHER

Undergo a structured interview

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Supportive Care

Intervention Type: OTHER

Receive standard SCP

Supportive Care

Intervention Type: OTHER

Receive a tailored SCP

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.

Group Type: ACTIVE_COMPARATOR

Interview

Intervention Type: OTHER

Undergo a structured interview

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Supportive Care

Intervention Type: OTHER

Receive standard SCP

Interventions

Educational Intervention

Receive a low literacy educational supplement

Intervention Type: OTHER

Interview

Undergo a structured interview

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Supportive Care

Receive standard SCP

Intervention Type: OTHER

Supportive Care

Receive a tailored SCP

Intervention Type: OTHER

Other Intervention Names

Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Supportive Therapy; Symptom Management; Therapy, Supportive; Supportive Therapy; Symptom Management; Therapy, Supportive

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Viraj Master

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viraj Master, MD, PhD, FACS

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status: RECRUITING

Atlanta VA Medical Center

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kerry L. Kilbridge, MD, MSc

Role: CONTACT

Kerry_Kilbridge@DFCI.HARVARD.EDU

617-632-2429

Facility Contacts

Sierra Williams

Role: primary

sierra.williams@emory.edu

404-778-4729

Sierra Williams

Role: primary

sierra.williams@emory.edu

404-778-4898

Sierra Williams

Role: primary

sierra.williams@emory.edu

4047784729

Other Identifiers

NCI-2024-08650

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00008365

Identifier Type: OTHER

Identifier Source: secondary_id

WINSHIP6368-24

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008365

Identifier Type: -

Identifier Source: org_study_id