Addressing Health Literacy With a Tailored Survivorship Care Plan

NCT06674863 | Recruiting

• 4 other identifiers: STUDY00008365NCI-2024-08650WINSHIP6368-24P30CA138292
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At baseline and up to 3 month phone call

Secondary Outcomes (5)

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

  At baseline and up to 3 month phone call

• Decision regret

  At baseline and up to 3 month phone call

• Change in decisional conflict

  At baseline and up to 3 month phone call

• Preparedness for survivorship

  At baseline and up to 3 month phone call

• Patient self-efficacy

  At baseline and up to 3 month phone call

Study Arms (2)

Group I (standard SCP, tailored SCP)

EXPERIMENTAL

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.

Other: Educational Intervention; Other: Interview; Other: Questionnaire Administration; Other: Supportive Care

Group II (standard SCP)

ACTIVE COMPARATOR

Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes.

Other: Interview; Other: Questionnaire Administration; Other: Supportive Care

Interventions

Interview OTHER

Undergo a structured interview

Group I (standard SCP, tailored SCP); Group II (standard SCP)

Questionnaire Administration OTHER

Ancillary studies

Group I (standard SCP, tailored SCP); Group II (standard SCP)

Supportive Care OTHER

Receive standard SCP

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Group I (standard SCP, tailored SCP); Group II (standard SCP)

Educational Intervention OTHER

Receive a low literacy educational supplement

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group I (standard SCP, tailored SCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator
• United States Department of Defense: collaborator

Study Sites (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Atlanta VA Medical Center

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Interviews as Topic; Palliative Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Patient Care; Therapeutics

Study Officials

• Viraj Master, MD, PhD, FACS

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerry L. Kilbridge, MD, MSc

CONTACT

617-632-2429; Kerry_Kilbridge@DFCI.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: November 7, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (3)