An interventional study of Educational Intervention and Interview in Localized Prostate Carcinoma, Oligometastatic Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by Emory University. Recruiting at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Emory University · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
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
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
Receive a low literacy educational supplement
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Undergo a structured interview
Ancillary studies
Receive standard SCP
Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Receive a tailored SCP
Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
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
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At baseline and up to 3 month phone call
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Emory University