Screening and navigation support for breast cancer patients

Early Point-of-Service SBDOH Screening in Breast Cancer

This study is testing a new tech-based tool to see if it helps breast cancer patients share important health information better than the usual methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abramson Cancer Center at Penn Medicine (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06019988 on ClinicalTrials.gov

What this trial studies

This project aims to enhance the collection of social and behavioral determinants of health (SBDOH) for patients diagnosed with breast cancer at Penn Medicine. It will implement a tech-enabled platform to administer a validated SBDOH screening tool, comparing it to the current unstructured methods. Patients will be randomized to one of three screening assessment tools, and study coordinators will facilitate communication and enrollment for those diagnosed with operable breast cancer. The study will measure various outcomes, including rates of data collection, referral uptake, and patient-centered communication.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 and older with a new diagnosis of operable (Stage 0-III) breast cancer who can read and speak English or Spanish.

Not a fit: Patients with known metastatic disease or those who do not wish to be contacted for research will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve care delivery and support services for breast cancer patients by addressing their social and behavioral health needs.

How similar studies have performed: Other studies have shown success in using structured screening tools to address social determinants of health, indicating potential for positive outcomes in this approach.

Eligibility criteria

Inclusion Criteria:

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:

* 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

Exclusion Criteria:

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.

Where this trial is running

Philadelphia, Pennsylvania

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Oluwadamilola Fayanju, MD — University of Pennsylvania Division of Breast Surgery
• Study coordinator: Julia T Lewandowski

Conditions: Breast Cancer, Social Determinants of Health, Social and behavioral determinants of health, SDOH, SBDOH