This clinical trial evaluates if early collection and identification of social and behavioral determinants of health (SBDOH) improves care delivery in patients with breast cancer. Delayed and incomplete treatment for female breast cancer is associated with worse survival after diagnosis. Different barriers, such as unmet practical needs (difficulty with transportation), contribute to delays in time to evaluation and treatment. Such barriers to care are frequently not identified until, and sometimes after, a patient's first oncologic appointment, by which time earlier opportunities to help eliminate these barriers and speed up care have already been missed. The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN), Health Leads Social Screening Tool, and National Comprehensive Cancer Network Distress Thermometer and Problem List (NCCN DT + PL) are tools used to collect patient SBDOH information that can be delivered to the patient through their electronic health record following their breast cancer diagnosis and prior to their first visit with a breast cancer specialist. SBDOH screening tools may help health care providers identify social barriers that can contribute to delays in treatment and help to eliminate these barriers to speed up care. Early collection and identification of SBDOH may improve care delivery in patients with breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06019988.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Oluwadamilola (Lola) Motunrayo Fayanju
Phone: 215-662-4392
PRIMARY OBJECTIVE:
I. Comparative rates of SBDOH data collection using 3 different self-administered instruments designed for SBDOH data capture (e.g., NCCN distress thermometer) compared versus (vs) usual care (i.e., unstructured data collection).
SECONDARY OBJECTIVES:
I. Comparative rates of SBDOH data collection by modality: Epic patient portal [MyPennMedicine], chatbot, telephone interactive voice response.
II. Time to evaluation (TTE, i.e., time from biopsy to first consultation with an oncologist).
III. Through qualitative research (e.g., semi-structured interviews), we will evaluate contextual mechanisms contributing to the effectiveness of data collection tools and modalities described in the trial.
OUTLINE:
ACTIVITY 1: Patients are randomized to receive 1 of 3 screening assessment tools.
SCREENING TOOL 1: Patients complete the AHC-HRSN via the MyPennMedicine patient portal over 5 minutes within 24 hours of breast cancer referral and prior to first visit with breast cancer specialist.
SCREENING TOOL 2: Patients complete the Health Leads Social Screening Tool via the MyPennMedicine patient portal over 10 minutes within 24 hours of breast cancer referral and prior to first visit with breast cancer specialist.
SCREENING TOOL 3: Patients complete the NCCN DT + PL via the MyPennMedicine patient portal over 5 minutes within 24 hours of breast cancer referral and prior to first visit with breast cancer specialist.
Patients who do not respond to assigned screening assessment tool via the MyPennMedicine patient portal within 48 hours are then randomized to receive the same screening assessment tool through 1 of 2 alternative modalities.
TEXT MESSAGE: Patients complete assigned screening assessment tool via a bidirectional text-based conversational agent (chatbox) on study. Patients who do not respond to the screening via chatbox are given a last opportunity to complete the screening at first oncological surgical/new patient visit.
PHONE CALL: Patients complete assigned screening assessment tool via an interactive voice response (IVR) system administered by phone on study. Patients who do not respond to the screening via IVR are given a last opportunity to complete the screening at first oncological surgical/new patient visit.
All patients also have their medical record reviewed on study.
ACTIVITY 2: Participants complete a semi-structured interview over 30 minutes on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorOluwadamilola (Lola) Motunrayo Fayanju
