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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06019988
Acronym
Breast_SBDOH
Enrollment
2500
Registered
2023-08-31
Start date
2024-03-11
Completion date
2026-09-30
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Social Determinants of Health (SDOH)

Keywords

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

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: 1. Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HSRN); 2. Health Leads Social Needs Screening Toolkit (Health Leads); 3. 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. Patients who do not respond and remain enrolled will be randomized to either a bidirectional text-based conversational agent (i.e., "chatbot") or interactive voice response (IVR) system administered by phone. Through the first arm, patients will engage with the screening tool through an interactive two-way text messaging chatbot through WaytoHealth©. Through the second arm, patients will be called over the phone and will receive the screening tool through interactive voice recognition. Patients will again have 48 hours to respond and will receive 2 reminders via the modality to which they have been newly randomized. Patients have the opportunity to opt out through either modality and discontinue study. Patients who have not completed the screen via any modality by the time of their first surgical consult at Penn after diagnosis, will be provided the opportunity to complete it electronically though a tablet at the clinic appointment. At any point, patients who report challenges with particular SBDOH domains can be referred prior to initial surgical consultation to Social Services at Abramson Cancer Center. Approximately 6 months following diagnosis and initial completion in the study trial (Activity 1), a subset of patients (identified via deviant sampling) will be invited to participate in semi-structured interviews (Activity 2) through which mechanisms contributing to the effectiveness of the SBDOH data collection platform will be evaluated. Additionally, clinicians or clinical leaders will be invited to participate in semi-structured interviews.

Interventions

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

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)

Sponsors

Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER
Gilead Sciences
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Rates of SBDOH screen completion prior to initial surgical consult1 yearRates 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.

Secondary

MeasureTime frameDescription
Time from biopsy to initial surgical consult1 yearsTime to evaluation (TTE) will be compared first 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.
Identify factors associated with rates of post-diagnosis, pre-consultation SBDOH screen completion6 monthsFactors associated with rates of SBDOH screen completion across all instruments (AHC-HRSN, Health Leads, and NCCN DT + PL) and modalities will be assessed via individual semi-structured qualitative interviews with patients who participate in Activity 1 as well as clinicians or clinical leaders.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOROluwadamilola Fayanju, MD

University of Pennsylvania Division of Breast Surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026