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

NCT07781800 | Not Yet Recruiting

• 1 other identifier: 202608090
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Cancer of Breast

Keywords

Patient navigation; Breast cancer; Social determinants of health; Navigator

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with chemotherapy deferrals

  6 months

Secondary Outcomes (2)

• Rate of visit no-shows

  6 months

• Rate of visit cancellations

  6 months

Study Arms (1)

Patient navigation intervention

EXPERIMENTAL

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.

Behavioral: Patient navigator

Interventions

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.

Patient navigation intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Comprehensive Cancer Network: collaborator
• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63310, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Emily L Podany, MD, MPHS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily L Podany, MD, MPHS

CONTACT

314-273-4474; elpodany@wustl.edu

Katherine N Weilbaecher, MD

CONTACT

314-362-5654; kweilbae@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)