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Health Leads Social Screening Tool 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

Breast SBDOH Trial 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.Check my eligibility

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.See study design

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.

Breast SBDOH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rates of SBDOH screen completion prior to initial surgical consult

Secondary outcome measures

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

Time from biopsy to initial surgical consult

Breast SBDOH 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

143,144 Total Patients Enrolled

44 Trials studying Breast Cancer

58,349 Patients Enrolled for Breast Cancer

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

845,762 Total Patients Enrolled

16 Trials studying Breast Cancer

3,954 Patients Enrolled for Breast Cancer

Oluwadamilola Fayanju, MDPrincipal InvestigatorUniversity of Pennsylvania Division of Breast Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being recruited for this research investigation?

"Yes, the details on clinicaltrials.gov indicate that this trial is presently enlisting participants. The trial was first listed on March 11, 2024 and most recently revised on the same date. It aims to recruit 2500 individuals from a single study site."

Answered by AI

Are there any ongoing opportunities for patients to participate in this medical study?

"Yes, the details on clinicaltrials.gov suggest that this trial is presently open to enrollment. The study was first listed on March 11th, 2024 and last modified on the same date. Recruitment aims at enrolling 2500 participants from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Oluwadamilola Fayanju, MD, MA, MPHS, FACS 2024. "Effect of Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhanced Navigation on Care Delivery for Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06019988.