RecruitingRecruiting
Addressing Health Literacy With a Tailored Survivorship Care Plan
NCT06674863 · Emory University
In plain English
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Official title
Addressing Health Literacy With a Tailored Survivorship Care Plan to Improve Access in Underserved African American Prostate Cancer Patients
About this study
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
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-07
Estimated completion: 2030-12-31
Last updated: 2025-12-09
Interventions
Other: Educational InterventionOther: InterviewOther: Questionnaire AdministrationOther: Supportive CareOther: Supportive Care
Primary outcomes
- • Comprehension of survivorship care recommendations and prostate specific antigen surveillance (At baseline and up to 3 month phone call)
- • Comprehension of treatment side effects and late effects (At baseline and up to 3 month phone call)
Sponsor
Emory University · other
With: National Cancer Institute (NCI), United States Department of Defense
Contacts & investigators
ContactKerry L. Kilbridge, MD, MSc · contact · Kerry_Kilbridge@DFCI.HARVARD.EDU · 617-632-2429
InvestigatorViraj Master, MD, PhD, FACS · principal_investigator, Emory University Hospital/Winship Cancer Institute
All locations (3)
Grady Memorial HospitalRecruiting
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Atlanta VA Medical CenterRecruiting
Atlanta, Georgia, United States