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SBDOH Screening for Breast Cancer (Breast_SBDOH Trial)

N/A

Recruiting

Led By Oluwadamilola Fayanju, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to improve how we gather information about the social and behavioral factors that can affect health in breast cancer patients at Penn Medicine. Researchers will track how this information is collected, how many patients are

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on screening methods rather than medical treatments, traditional physical side effects are not applicable. However, there may be emotional or psychological impacts from discussing personal social and behavioral health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rates of SBDOH screen completion prior to initial surgical consult

Secondary study objectives

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

Time from biopsy to initial surgical consult

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: The Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)Experimental Treatment1 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 Treatment1 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) SystemExperimental Treatment1 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 ToolExperimental Treatment1 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: ChatbotExperimental Treatment1 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.

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