Breast_SBDOH
Early Point-of-Service SBDOH Screening in Breast Cancer
Sponsor study identifier
interventional
2,500
1 country
1
Study Start
March 11, 2024
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 25, 2023
Actual (reported)August 31, 2023
Actual (reported)March 11, 2024
Actual (reported)September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rates of SBDOH screen completion prior to initial surgical consult
Rates of SBDOH screen completion prior to initial surgical consult will be first compared by instrument (Accountable Health Communities Health-Related Social Needs Screening Tool \[AHC-HRSN\], Health Leads Social Needs Screening Toolkit \[Health Leads\], National Comprehensive Cancer Network Distress Thermometer and Problem List \[NCCN DT + PL\]). Only the NCCN DT employs a 10-point Likert scale, where 0 = no distress and 10 = extreme distress. Among patients who do not respond to initial screening administration and who then receive the screening via either chatbot or IVR, rates of SBDOH screen completion will be compared by modality.
1 year
Time from biopsy to initial surgical consult
1 years
Identify factors associated with rates of post-diagnosis, pre-consultation SBDOH screen completion
6 months
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.
Patients will be randomized to receive one of three social needs screening instruments. Health Leads is an 8-item survey with yes/no responses, which screens for food insecurity, utility needs, housing instability, childcare, financial resource strain, transportation challenges, education, and social isolation.
All patients who participate in the trial will receive one of three social and behavioral determinants of health (SBDOH) screening instruments (AHC-HRSN, Health Leads, or NCCN DT + PL). Any patients who do not complete the screening within 48 hours of its administration will be randomized to receive the same screening via one of two modality arms (Chatbot or IVR System)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Reddy KP, Mirpuri S, Berkowitz CL, de Jesus EM, Hulse SB, Lewandowski JT, Coughlin KQ, Burwell ML, Evans R, Galetta J, Rivera Sanchez S, Buckingham TL, Livingstone V, McCarthy AM, Gabriel PE, Edmonds CE, Cadet TJ, Fayanju OM. Implementing social and behavioral determinants of health data collection: insights from a pragmatic trial. JNCI Cancer Spectr. 2025 Apr 30;9(3):pkaf040. doi: 10.1093/jncics/pkaf040.
Oluwadamilola Fayanju, MD
University of Pennsylvania Division of Breast Surgery
First Submitted
August 25, 2023
First Posted
August 31, 2023
Breast Cancer Outreach Among Primary Care Patients
Patients will be randomized to receive one of three social needs screening instruments. The NCCN Distress thermometer is a single-item tool designed to measure patients' current level of distress. Patients are asked to rate their distress using a 10-point Likert scale, where 0=no distress and 10=extreme distress. The Problem List (PL) helps physicians identify the sources of patients' distress and direct patients to appropriate support services. The NCCN DT+PL is a widely used, validated tool for evaluating distress in patients diagnosed with or receiving treatment for cancer.
Patients who do not respond to the survey within 48 hours of being first administered via MyPennMedicine will be sent the same survey via one of two modality arms. The chatbot is a bidirectional text-based conversational agent administered via WaytoHealth. Patients will again have 48 hours to respond via chatbot.
Patients who do not respond to the survey within 48 hours of being first administered via MyPennMedicine will be sent the same survey via one of two modality arms. The interactive voice response (IVR) system is administered via phone through WaytoHealth. Patients will be called over the phone and will receive the screening tool through IVR. Patients will again have 48 hours to respond via IVR.
Contact the study team to confirm eligibility.
Study Start
March 11, 2024
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 11, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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