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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
Black and Latina women experience disparities in supportive and palliative care access and outcomes. The goal of the proposed pilot study is to evaluate the feasibility and acceptability of a community navigator delivered supportive care intervention for historically underserved populations of women with metastatic breast cancer.
Primary Objectives: 1. Establish the feasibility and acceptability of an adapted navigator delivered supportive care model called ACCESS to address supportive care needs for Black and Latina women with Metastatic Breast Cancer. 2. Determine the potential impact of ACCESS on cancer related distress, symptom burden, and utilization of supportive care services. OUTLINE: Participants (N=60) are randomized to 1 of 2 groups: GROUP 1/Intervention Group: Participants complete 6 individualized behavioral/educational sessions focused on social determinants of health and supportive care with a trained community navigator followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 and 9 months. GROUP 2/Attention Control group: Participants complete 6 phone calls with a research coordinator focused on supportive care resources followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 months and 9 months. .
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Mount Sinai Hospital
New York, New York, United States
Start Date
May 1, 2024
Primary Completion Date
July 31, 2026
Completion Date
November 30, 2026
Last Updated
November 5, 2025
67
ESTIMATED participants
ACCESS Supportive Care
BEHAVIORAL
Phone sessions
BEHAVIORAL
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
NCT06625775
NCT06649331
Data Source & Attribution
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