Early Point-of-Service SBDOH Screening in Breast Cancer

Abramson Cancer Center at Penn Medicine1 site in 1 country2,500 target enrollmentStarted: March 11, 2024Last updated: June 11, 2026

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 2,500
Locations: 1
Primary Endpoint: Rates of SBDOH screen completion prior to initial surgical consult

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

The overarching goal of this project is to optimize the collection of social and behavioral determinants of health (SBDOH) for patients with a pathological diagnosis of breast cancer at Penn Medicine. The investigators will measure rates of SBDOH data collection by modality and rates of referral to and uptake of social support services, time to evaluation, staff time, acceptability, patient-centered communication, medical mistrust, and clinician acceptability.

Detailed Description

The investigators will conduct a patient-level, pragmatic opt-out trial to test implementation of a comprehensive, tech-enabled platform for administration of a validated SBDOH screening tool in contrast to the current practice of unstructured social history collection at this institution.

For internally referred patients, study coordinators - who are functioning as patient navigators - will facilitate a warm handoff from radiology to the New Patient Office as well as study introduction and enrollment. If patients do not wish to have a warm handoff call with a new-patient coordinator (NPC) in the NPO who will schedule the patient's consult with a surgeon and/or oncologist, or if patients are diagnosed external to Penn Medicine, the patient coordinator will follow up directly with the patient to facilitate communication and enrollment within 24 hours of diagnosis.

All patients who do not opt out will be part of the analytic cohort and randomized to one of three screening assessment tools:

Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HSRN);
Health Leads Social Needs Screening Toolkit (Health Leads);
National Comprehensive Cancer Network (NCCN) Distress Thermometer + Problem List (NCCN DT+PL).

. The initial request for completion will be administered via the institutional EHR's Epic-based patient portal. Patients will have 48 hours to respond and will receive 2 reminders via a MyPennMedicine message (MPM), through which a patient can also indicate a desire to opt-out if they wish.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Screening
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Based on available EHR data, patients will be eligible for Activities 1 and 2 if they:
•Are referred to one of the following locations for surgical consult following a new diagnosis of operable (Stage 0-III) breast cancer: the Hospital of the University of Pennsylvania (HUP), Penn Presbyterian Medical Center (PPMC), Pennsylvania Hospital (PAH), and Penn Medicine Radnor
•Are female
•Are 18 years of age or older, and
•Are able to read and speak English or Spanish
•Clinicians and clinical leaders will be eligible for participation in Activity 2 if they:
•Presently work as a clinician or clinical leader in breast surgery or oncology
•Access PennChart as an aspect of their clinical duties
•Are 18 years of age or older
•Are able to read and speak English or Spanish

Exclusion Criteria

•Based on available EHR data, patients will be ineligible if they:
•Are listed as not wanting to be contacted or solicited for research;
•Have known metastatic disease at time of enrollment; and/or
•Do not otherwise meet all of the enrollment criteria
•Clinicians and clinical leaders will be ineligible for participation in Activity 2 if they:
•Are not presently engaged in clinical duties or
•Do not otherwise meet all of the enrollment criteria
•This study will not exclude men or nonbinary people who may be diagnosed with breast cancer, but investigators anticipate the sample size for these characteristics will be too small to support meaningful analysis.

Arms & Interventions

The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)

Other

Patients will be randomized to receive one of three social needs screening instruments. The AHC-HRSN is a 10-item tool developed by the Centers for Medicare and Medicaid Services to assess patient needs in 5 core domains, including housing instability, food insecurity, transportation problems, utility help needs, and interpersonal safety, with eight supplemental domains to collect information about financial strain, employment, family and community support, education, physical activity, substance abuse, mental health, and disabilities. The AHC-HRSN tool is designed to help physicians identify unmet needs and refer affected patients to appropriate community services.