Clinical trial NCT06674863: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Localized Prostate Carcinoma
Oligometastatic Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: United States Department of Defense
First posted: 2024-11-05
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Comprehension of survivorship care recommendations and prostate specific antigen surveillance
timeFrame: At baseline and up to 3 month phone call
measure: Comprehension of treatment side effects and late effects
timeFrame: At baseline and up to 3 month phone call
Secondary outcomes:
measure: Access to survivorship care for late and long-term side effects
timeFrame: At baseline and up to 3 month phone call
measure: Decision regret
timeFrame: At baseline and up to 3 month phone call
measure: Change in decisional conflict
timeFrame: At baseline and up to 3 month phone call
measure: Preparedness for survivorship
timeFrame: At baseline and up to 3 month phone call
measure: Patient self-efficacy
timeFrame: At baseline and up to 3 month phone call
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Viraj Master, MD, PhD, FACS
role: PRINCIPAL_INVESTIGATOR
References: