Breast CancerBreast_SBDOHNCT06019988

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

A study testing Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening in people with Breast Cancer and Social Determinants of Health (SDOH), run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Social Determinants of Health (SDOH)
What is being tested?: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,500 participants
Where: 1 siteUnited States
Study dates: 11 Mar 2024to 30 Sep 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 10Show fewer

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Early Point-of-Service SBDOH Screening in Breast Cancer

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.

Read the 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. 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.

Conditions: Breast Cancer, Social Determinants of Health (SDOH)
Being tested: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening
Keywords: Social and behavioral determinants of health, SDOH, SBDOH, Breast Cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06019988
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year

Secondary outcomes (2)

Time from biopsy to initial surgical consult
Time 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.
Measured: 1 years
Identify factors associated with rates of post-diagnosis, pre-consultation SBDOH screen completion
Factors 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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 202430 Sep 2026

First posted31 Aug 2023
Study start11 Mar 2024
Primary completion30 Sep 2026 (estimated)
Study completion30 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: None (open label)
Enrolment: 2,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06019988
Sponsor's protocol ID: 19122
Acronym: Breast_SBDOH
Status last verified: Jun 2026
First submitted: 25 Aug 2023
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 40408149

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Point-of-Service SBDOH Screening in Breast Cancer
ClinicalTrials.gov ID: NCT06019988
Acronym / sponsor ID: Breast_SBDOH / 19122
Conditions: Breast Cancer, Social Determinants of Health (SDOH)
Keywords: Social and behavioral determinants of health, SDOH, SBDOH, Breast Cancer
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 2,500 participants (estimated)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Collaborators: Gilead Sciences
Study start: 11 Mar 2024 (actual)
Primary completion: 30 Sep 2026 (estimated)
Study completion: 30 Sep 2026 (estimated)
First posted: 31 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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. 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.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5
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).

Arm	Type	Receives
The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)	Other	Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) ScreeningPatients 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.
Health Leads Social Screening Tool	Other	Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) ScreeningPatients 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.
National Comprehensive Care Network (NCCN) Distress Thermometer and Problem List (DT + PL)	Other	Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) ScreeningPatients 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.
Chatbot	Other	Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) ScreeningPatients 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.
Interactive Voice Response (IVR) System	Other	Other: Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) ScreeningPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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
Presently work as a clinician or clinical leader in breast surgery or oncology

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) ScreeningAll 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)	Other	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)

Primary outcome

Rates of SBDOH screen completion prior to initial surgical consult
Time frame: 1 year
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.

2 secondary outcomes

Time from biopsy to initial surgical consult
Time frame: 1 years
Identify factors associated with rates of post-diagnosis, pre-consultation SBDOH screen completion
Time frame: 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Derived from this study: PubMed 40408149Reddy 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oluwadamilola Fayanju, MD principal investigator

University of Pennsylvania Division of Breast Surgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of SBDOH screen completion prior to initial surgical consult (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06019988, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.