Navigation Interventions for Patients With Breast Cancer and High-risk Social Determinants of Health

NCT07781800 — Not applicable, Recruiting, 180 participants, Washington University School of Medicine

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From Screening to Action: Implementing Navigation Interventions for Patients With Breast Cancer and High-risk Social Determinants of Health

Registry	NCT07781800
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, health services research
Enrollment	180 (Estimated)
Sponsor	Washington University School of Medicine (Other); collaborators: National Comprehensive Cancer Network
Conditions	Breast Cancer, Cancer of Breast
Interventions	Patient navigator (Behavioral)
Dates	start 2026-10-14, primary completion 2028-10-31 (estimated), completion 2028-10-31 (estimated), first posted 2026-08-24, last updated 2026-10-21
Locations	1 site in United States

-Summary

This study aims to assess how individual patient social stressors are associated with barriers to care by analyzing a patient navigator system. Patient navigators will connect patients with unmet social needs with community resources.

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+Arms and interventions

Arm	Type	Interventions	Description
Patient navigation intervention	Experimental	Behavioral: Patient navigator	Patients will be connected with a patient navigator following consent. The navigator will ask the patient questions regarding social determinants of health risks including transportation difficulties, financial stability, and housing stability. Patient will receive full social determinants of health (SDOH) screening via iPad at initial consult visit. Based on SDOH screening, if the patient is high risk the patient will be referred to appropriate resources.

Patient navigator (Behavioral): Patient navigator will contact the patient every 3 weeks to check in, assess if patient requires additional resources, connect patient to existing nonprofit and local resources, remind patient of appointments, and ask about barriers to clinic visits.

+Outcome measures

Primary outcomes

Percentage of patients with chemotherapy deferrals [6 months]

Secondary outcomes

Rate of visit no-shows [6 months]
Rate of visit cancellations [6 months]

+Eligibility

Sex: Female, ages: 18 Years to any

Eligibility Criteria:

* Diagnosed with breast cancer (any stage).
* Currently being treated for breast cancer by a breast medical oncologist at Siteman Cancer Center North County. This includes any treatment, PO or IV, including hormonal therapy. It does not include patients enrolled in clinical trials.
* At least 18 years of age.
* English-speaker.
* Verbally consented to navigation services.

+Locations (1)

Facility	City	Country	Status
Washington University School of Medicine	St Louis, Missouri	United States	Recruiting

+Investigators

Emily L Podany, MD, MPHS, Principal investigator, Washington University School of Medicine