Clinical trial · Interventional
Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhanced Navigation on Care Delivery for Patients With Breast Cancer
Early Point-of-Service SBDOH Screening in Breast Cancer
NCT06019988CI-TRIAL-00114479Breast_SBDOHactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Social Determinants of Health (SDOH) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- OTHER
- label
- The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)
- description
- 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.
- interventionNames
- Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening
- type
- OTHER
- label
- Health Leads Social Screening Tool
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDReddy 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. PMID 40408149