SBDOH Screening for Breast Cancer

(Breast_SBDOH Trial)

Overseen By Sarah B Hulse

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best methods for collecting information on social and behavioral factors affecting the health of breast cancer patients at Penn Medicine. It compares different screening tools to determine which most effectively identifies patients' needs, such as food insecurity or housing instability, and connects them to support services. Women recently diagnosed with early-stage (Stage 0-III) operable breast cancer and referred for surgery at specific Penn Medicine locations may be eligible to participate. The trial ensures that patients receive necessary social support alongside medical treatment. As an unphased trial, it offers patients the opportunity to contribute to improving supportive care for future breast cancer patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these screening tools are safe for patients with breast cancer?

Research shows that Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening gathers information on social and behavioral factors that might impact health. This process uses surveys or tools to inquire about housing, food security, and stress. Tools like the Health Leads Social Screening Tool or the NCCN Distress Thermometer have been used before and are generally well-received by patients.

Past studies have not reported harm or negative effects from these screenings. They primarily involve asking questions to determine what support someone might need. The goal is to understand personal situations and connect people to resources if necessary. While specific data does not show harm from these studies, collecting information this way is generally safe and does not involve any physical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how early screening for social and behavioral health factors can impact breast cancer care. Unlike typical treatments that focus solely on the medical aspects of cancer, this trial looks at how factors like food insecurity, housing instability, and distress can affect a patient's journey. The unique screening tools used in this trial—like the Health Leads Social Screening Tool and the AHC-HRSN—are designed to identify these needs early, aiming to provide a more holistic approach to patient care. By addressing these social determinants alongside medical treatment, the hope is to improve outcomes and support for patients in a more comprehensive way.

What evidence suggests that this trial's screening tools could be effective for breast cancer patients?

Research shows that understanding social and personal needs can enhance breast cancer care. In this trial, participants will be randomized to receive one of three social needs screening instruments. The Health Leads Social Screening Tool identifies issues like lack of food or housing, which can hinder proper care. By detecting these issues early, healthcare teams can address them before they impact treatment. The NCCN Distress Thermometer and Problem List identify stress in cancer patients, guiding them to necessary support. The Accountable Health Communities Health-Related Social Needs Screening Tool connects patients with useful community services. Additionally, for those who do not initially respond, the trial will use Chatbots and Interactive Voice Response systems to administer the surveys. These methods have increased breast cancer knowledge and encouraged more people to access health services like mammograms. All these tools aim to improve the support breast cancer patients receive. ^{1 6 7 8 9}

Who Is on the Research Team?

Oluwadamilola Fayanju, MD

Principal Investigator

University of Pennsylvania Division of Breast Surgery

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who have been newly diagnosed with operable breast cancer (Stage 0-III) and are referred to specific Penn Medicine locations. Participants must be able to read and speak English or Spanish.

Exclusion Criteria

I am currently working in clinical duties and meet all enrollment criteria.

I am open to being contacted for research and do not have cancer that has spread at the time of joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

SBDOH Screening

Participants complete social and behavioral determinants of health screening using one of three tools: AHC-HRSN, Health Leads, or NCCN DT+PL

48 hours per screening attempt

Remote via patient portal, chatbot, or IVR

Initial Surgical Consultation

Participants have their first surgical consult at Penn after diagnosis, with an opportunity to complete the SBDOH screen if not done previously

Within 6 months post-diagnosis

1 visit (in-person)

Follow-up

Participants are monitored for factors associated with SBDOH screen completion and participate in semi-structured interviews

6 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests how well early screening for social and behavioral factors affects care for breast cancer patients. It looks at data collection rates, referrals to support services, timeframes, staff involvement, communication quality, trust in medical services, and clinician views.

How Is the Trial Designed?

Group I: The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN) Experimental Treatment 1 Intervention

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.

Group II: National Comprehensive Care Network (NCCN) Distress Thermometer and Problem List (DT + PL) Experimental Treatment 1 Intervention

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.

Group III: Interactive Voice Response (IVR) System Experimental Treatment 1 Intervention

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.

Group IV: Health Leads Social Screening Tool Experimental Treatment 1 Intervention

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.

Group V: Chatbot Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

Cancer screening rates for cervical, breast, and colorectal cancers significantly decreased in 2020 compared to 2014-2019, particularly affecting underserved racial groups such as American Indian/Alaskan Natives and Hispanics.

The decline in screening is expected to worsen in 2021, potentially increasing cancer disparities in the U.S., highlighting the urgent need to address these gaps in healthcare access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in Standard Cancer Screening in 2020 throughout the U.S. Dennis, LK., Hsu, CH., Arrington, AK.[2021]

Implementing a screening process for adverse social and behavioral determinants of health (SBDOHs) in a school-based clinic was feasible, with most screenings taking 5 minutes or less.

The screening significantly increased the identification of adverse SBDOHs and led to more referrals and interventions compared to encounters before the screening was introduced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for the Social and Behavioral Determinants of Health at a School-Based Clinic. Barton, LR., Parke, KA., White, CL.[2020]

In a study of 22,657 women, only about 47% of black and Hispanic women and 50% of white women reported having a recent mammogram, highlighting a significant gap in breast cancer screening utilization.

Key factors influencing breast cancer screening rates included having a routine examination in the past year, seeing a specialist, and having more than a high school education, indicating that targeted strategies are needed to improve screening among underrepresented groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of screening mammography and clinical breast examinations among black, Hispanic, and white women. Frazier, EL., Jiles, RB., Mayberry, R.[2022]

In a study of 11,962 women aged 50-74 within an urban safety-net health system, the breast cancer screening (BCS) rate was found to be 69.7%, with significant disparities based on sociodemographic factors such as race and language proficiency.

Patients who were non-White, had limited English proficiency, or were served by female or internal medicine-trained providers had higher odds of undergoing BCS, highlighting the importance of addressing these factors to improve screening rates among underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unique Breast Cancer Screening Disparities in a Safety-Net Health System. Allar, BG., Torres, M., Mahmood, R., et al.[2023]

A study involving 933 women aged 40-70 in England found that 85% viewed breast cancer risk assessment positively, and 74% were willing to participate in it, indicating strong support for risk stratification in breast screening.

While 70% of participants supported risk-stratified screening, many were hesitant to accept less frequent or no screening if identified as very low risk, highlighting a need for careful communication about the benefits and implications of risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes towards risk-stratified breast cancer screening among women in England: A cross-sectional survey. Ghanouni, A., Sanderson, SC., Pashayan, N., et al.[2021]

In a study of 8,943 Medicaid enrollees, it was found that individuals from the most disadvantaged social determinants of health group were significantly less likely to receive colorectal, breast, and cervical cancer screenings compared to those from less disadvantaged groups, indicating a clear link between social factors and screening rates.

Interestingly, those in the most disadvantaged group were more likely to receive fecal occult blood tests, suggesting that while overall screening rates are lower, certain tests may be more accessible or prioritized in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Social Determinants on Cancer Screening in a Medicaid Sample. Markus, AR., Li, Y., Wilder, ME., et al.[2023]

In a study analyzing Medicare patients diagnosed with various cancers in 1995, it was found that those who utilized preventive and cancer screening services had a lower risk of being diagnosed with late-stage cancer, regardless of race or socioeconomic status.

The findings suggest that increased use of preventive services can lead to better health outcomes for elderly cancer patients, indicating that promoting these services could help reduce disparities in cancer diagnosis and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of race, education, and patterns of preventive service use with stage of cancer at time of diagnosis. Gornick, ME., Eggers, PW., Riley, GF.[2022]

A systematic review of 144 studies found that interventions addressing social determinants of health (SDOH) increased cancer screening rates by a median of 8.4 percentage points, highlighting the importance of these factors in improving screening access and demand.

Most effective interventions focused on healthcare access and quality, with those incorporating health policy and cost analyses showing the strongest positive impact on screening outcomes, suggesting that addressing these SDOH can significantly reduce inequities in cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social determinants of health and US cancer screening interventions: A systematic review. Korn, AR., Walsh-Bailey, C., Correa-Mendez, M., et al.[2023]

A study of 3142 counties found that cancer screening rates for breast, cervical, and colorectal cancers increased with higher levels of racial and economic privilege, indicating significant disparities in access to care based on social determinants of health.

The disparities in cancer screening uptake were largely explained by factors such as poverty, lack of health insurance, urban-rural location, and access to primary care, highlighting the need for targeted interventions to improve equity in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators of county-level racial and economic privilege in cancer screening. Munir, MM., Woldesenbet, S., Alaimo, L., et al.[2023]

In a study involving 137 patients with newly diagnosed gastrointestinal cancer, 81.8% were successfully screened for social determinants of health (SDOH) using an electronic health record (EHR) tool, indicating that routine SDOH screening is feasible in outpatient oncology settings.

The implementation of SDOH screening did not significantly increase clinic visit times, with median times remaining stable before and after the screening, and both patients and clinicians found the process acceptable, although staff reported some workflow barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Study to Evaluate the Feasibility and Acceptability of Implementing an Electronic Health Record Social Determinants of Health Screening Instrument into Routine Clinical Oncology Practice. Hao, SB., Jilcott Pitts, SB., Iasiello, J., et al.[2023]

Citations

1. cms.gov cms.gov/priorities/innovation/files/worksheets/ahcm-screeningtool.pdf

The AHC Health-Related Social Needs Screening Tool Just like with clinical assessment tools, providers can use the results from the HRSN Screening Tool to inform patients' treatment plans and make referrals to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11491583/

The Relationship Between Health-Related Social Needs ... In this study, we examined the relationship between health-related social needs (HRSNs) and screening mammography. Methods: We gathered data ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP-24-00902

Screening and Referral for Health-Related Social Needs ... Health-related social needs (HRSNs) are associated with adverse cancer health outcomes. We assessed the processes for screening and ...

4. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7315e1.htm

Vital Signs: Mammography Use and Association with ... A guide to using the accountable health communities health-related social needs screening tool: promising practices and key insights.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12107698/

Implementing social and behavioral determinants of health ... AHC-HRSN = Accountable Health Communities Health-Related Social Needs Screening Tool ... Unmet social needs and breast cancer screening utilization and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06019988/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 Social and Behavioral Determinants ... The overarching goal of this project is to optimize the collection of social and behavioral determinants of health (SBDOH) for patients with ...

7. pa.gov pa.gov/agencies/health/newsroom/shapiro-administration-touts-new-ai-model-for-breast-cancer

Shapiro Administration Touts New AI Model for Breast ... Advancements in preventive services, such as Geisinger's new pilot program, advance breast cancer care by using AI to identify patients at ...

8. pc3i.upenn.edu pc3i.upenn.edu/our-work/projects/breast-sbdoh/

Breast SBDOH: Optimizing Collection of Social and ... Breast SBDOH is identifying patient-reported outcome measures (PROMs) for social and behavioral determinants of health (SBDoH) data collection.

9. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21801

Social determinants of health and US cancer screening ... SDOH interventions increased screening rates overall by a median of 8.4 percentage points (interquartile interval, 1.8–18.8 percentage points).