Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhanced Navigation on Care Delivery for Patients With Breast Cancer

NCT06019988 | Active Not Recruiting

• 1 other identifier: 19122
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Social Determinants of Health (SDOH)

Keywords

Social and behavioral determinants of health; SDOH; SBDOH; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Time from biopsy to initial surgical consult

  1 years

• Identify factors associated with rates of post-diagnosis, pre-consultation SBDOH screen completion

  6 months

Study Arms (5)

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.

Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening

Health Leads Social Screening Tool

OTHER

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.

Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening

National Comprehensive Care Network (NCCN) Distress Thermometer and Problem List (DT + PL)

OTHER

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.

Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening

Chatbot

OTHER

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.

Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening

Interactive Voice Response (IVR) System

OTHER

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.

Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening

Interventions

Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening OTHER

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)

Chatbot; Health Leads Social Screening Tool; Interactive Voice Response (IVR) System; National Comprehensive Care Network (NCCN) Distress Thermometer and Problem List (DT + PL); The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 40408149 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Oluwadamilola Fayanju, MD

  University of Pennsylvania Division of Breast Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All enrolled patients will initially receive one of three screening tools (The Accountable Health Communities Health-Related Social Needs Screening Tool \[AHC-HRSN\], Health Leads Social Screening Tool, or National Comprehensive Care Network Distress Thermometer and Problem List \[NCCN DT+PL\]) via the MyPennMedicine patient portal and be given 48 hours to respond. Those patients who do not respond will be randomized to one of two intervention arms, each of which is an alternative modality to receive and respond to the assigned screening tool: a bidirectional text-based conversational agent (chatbot) or interactive voice response system administered by phone. There exists three instrument arms (AHC-HRSN, Health Leads, and NCCN DT+PL) and two modality arms (chatbot and IVR).

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: March 11, 2024
• Primary Completion: March 11, 2026
• Study Completion: March 11, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)