Addressing Health Literacy With a Tailored Survivorship Care Plan

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

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.

Study Overview

• Status: Recruiting
• Conditions: Localized Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8; Oligometastatic Prostate Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Intervention; Other: Interview; Other: Supportive Care; Other: Supportive Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerry L. Kilbridge, MD, MSc; Phone Number: 617-632-2429; Email: Kerry_Kilbridge@DFCI.HARVARD.EDU

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital/Winship Cancer Institute
      • Contact: Sierra Williams; Phone Number: 404-778-4898; Email: sierra.williams@emory.edu
      • Principal Investigator: Viraj Master, MD, PhD, FACS
    • Atlanta, Georgia, United States, 30303
      • Recruiting
      • Grady Memorial Hospital
      • Contact: Sierra Williams; Phone Number: 404-778-4729; Email: sierra.williams@emory.edu
      • Principal Investigator: Viraj Master, MD, PhD, FACS
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Atlanta VA Medical Center
      • Principal Investigator: Viraj Master, MD, PhD, FACS
      • Contact: Sierra Williams; Phone Number: 4047784729; Email: sierra.williams@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Receive a low literacy educational supplement; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Interview; Undergo a structured interview; Other: Supportive Care; Receive standard SCP; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive; Other: Supportive Care; Receive a tailored SCP; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive
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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Undergo a structured interview; Other: Supportive Care; Receive standard SCP; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive; Other: Supportive Care; Receive a tailored SCP; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access to survivorship care for late and long-term side effects	Will be assessed using the Patients Access Score (PAS). Descriptive statistics will be used to characterize patient access to survivorship care. The difference in mean PAS will be compared between the two arms using a 2 sample t-test. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Linear regression models will be used to identify predictors of access to survivorship care. Parsimonious models will be favored due to the relatively small sample size.	At baseline and up to 3 month phone call
Decision regret	Descriptive statistics will be used to characterize decision regret. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Parsimonious models will be favored due to the relatively small sample size.	At baseline and up to 3 month phone call
Change in decisional conflict	The two-sample t-test will be used to evaluate the change in the average decisional conflict score between patients in the control arm (standard SCP) and patients in the intervention arm (standard SCP + tailoring + educational supplement).	At baseline and up to 3 month phone call
Preparedness for survivorship	Descriptive statistics will be used to characterize preparedness for survivorship. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Parsimonious models will be favored due to the relatively small sample size.	At baseline and up to 3 month phone call
Patient self-efficacy	Descriptive statistics will be used to characterize patient self-efficacy. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Parsimonious models will be favored due to the relatively small sample size.	At baseline and up to 3 month phone call

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI); United States Department of Defense
• Investigators: Principal Investigator: Viraj Master, MD, PhD, FACS, Emory University Hospital/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Patient Care; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Methods; Interviews as Topic; Palliative Care; Early Intervention, Educational; Educational Status
• Other Study ID Numbers: STUDY00008365 (Other Identifier: Emory University Hospital/Winship Cancer Institute); P30CA138292 (U.S. NIH Grant/Contract); NCI-2024-08650 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); WINSHIP6368-24 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No