Improving support for Black and Latina women with metastatic breast cancer
Official title: Project ACCESS: A Pilot Randomized Controlled Trial of a Navigator Delivered Model to Enhance Access to Supportive Services for Women of Color With Metastatic Breast Cancer
Run by Icahn School of Medicine at Mount Sinai · NCT06405828 · Data updated 2026-11-12
This study is testing a new support program for Black and Latina women with metastatic breast cancer to see if it helps them feel better and access more resources compared to standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 67 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT06405828 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 and older who self-identify as Latina and/or African American/Black and have a diagnosis of Stage IV breast cancer.
✕Probably not a fit
Patients with moderate to severe cognitive impairment or those currently receiving inpatient hospice care may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate the feasibility and acceptability of a supportive care intervention called ACCESS, specifically designed for Black and Latina women with metastatic breast cancer. Participants will be randomized into two groups: one receiving individualized sessions with a community navigator focusing on social determinants of health, and the other receiving standard supportive care resource information. The study will assess the impact of this intervention on cancer-related distress, symptom burden, and the utilization of supportive care services over a period of nine months.
Why it matters
Potential benefit: If successful, this intervention could significantly improve access to supportive services and overall well-being for women of color facing metastatic breast cancer.
How similar studies have gone: Other studies have shown success in using community navigators to improve access to care for underserved populations, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women ≥18 years of age * English and/or Spanish speaking * Self-identify as Latina and/or African American/Black * Ability to understand and the willingness to sign a written informed consent * Stage IV breast cancer diagnosis, no time component Exclusion Criteria: * Moderate to severe cognitive impairment * receiving inpatient hospice care * if patients were previously enrolled in Aim 1 and Aim 2 * currently working with a community navigator
Where it's running
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Mount Sinai Hospital
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Melissa Mazor — Icahn School of Medicine at Mount Sinai
- Study coordinator: Melissa Mazor
- Email: melissa.mazor@mountsinai.org
- Phone: (510) 418-8642
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.