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

2500 Participants Needed

Trial Summary

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 data supports the idea that SBDOH Screening for Breast Cancer is an effective treatment?

The available research shows that interventions considering social and behavioral determinants of health (SBDOH) can increase cancer screening rates. A systematic review found that SBDOH interventions increased screening rates by a median of 8.4 percentage points. These interventions focused on improving access to healthcare and quality, which were linked to better screening outcomes. This suggests that SBDOH screening can be an effective way to increase breast cancer screening rates and reduce disparities in healthcare access. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening for breast cancer?

Research shows that screening interventions considering social and behavioral factors can increase cancer screening rates by a median of 8.4 percentage points, suggesting that addressing these factors can improve access and demand for cancer screenings. ^{1 2 3 4 5}

What safety data exists for SBDOH Screening for Breast Cancer?

The provided research does not directly address safety data for SBDOH Screening for Breast Cancer or Early Point-of-Service SBDOH Screening. The studies focus on disparities in breast cancer screening, the impact of social determinants of health on screening interventions, and changes in screening rates due to the COVID-19 pandemic. None of the studies specifically evaluate the safety of the SBDOH screening intervention. ^{3 6 7 8 9}

Is Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening a promising treatment for breast cancer?

Yes, Early Point-of-Service SBDOH Screening is a promising treatment for breast cancer. It helps identify and address social and behavioral factors that can affect health, which can lead to better health outcomes. Studies show that considering these factors in cancer screening can increase screening rates and improve access to care, making it a valuable approach in reducing health inequities. ^{2 3 4 5 10}

How does Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening differ from other breast cancer treatments?

This treatment is unique because it focuses on screening for social and behavioral factors that can affect health, rather than directly targeting the cancer itself. By identifying and addressing these factors early, it aims to improve overall health outcomes and potentially increase the effectiveness of traditional cancer screenings. ^{2 3 4 5 10}

What is the purpose of this trial?

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.

Research Team

Oluwadamilola Fayanju, MD

Principal Investigator

University of Pennsylvania Division of Breast Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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 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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Associations of race, education, and patterns of preventive service use with stage of cancer at time of diagnosis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Social determinants of health and US cancer screening interventions: A systematic review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mediators of county-level racial and economic privilege in cancer screening. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The Influence of Social Determinants on Cancer Screening in a Medicaid Sample. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Use of screening mammography and clinical breast examinations among black, Hispanic, and white women. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Unique Breast Cancer Screening Disparities in a Safety-Net Health System. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Reduction in Standard Cancer Screening in 2020 throughout the U.S. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Attitudes towards risk-stratified breast cancer screening among women in England: A cross-sectional survey. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Screening for the Social and Behavioral Determinants of Health at a School-Based Clinic. [2020]