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NCT06405828 | RECRUITING | Metastatic Breast Cancer

Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer
Sponsor:

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Melissa Mazor

Brief Summary:

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.

Condition or disease

Metastatic Breast Cancer

Stage IV Breast Cancer AJCC V7

Intervention/treatment

ACCESS Supportive Care

Phone sessions

Phase

NA

Detailed Description:

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. .

Study Type : INTERVENTIONAL
Estimated Enrollment : 67 participants
Masking : DOUBLE
Primary Purpose : SUPPORTIVE_CARE
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
Actual Study Start Date : 2024-05-01
Estimated Primary Completion Date : 2026-07-31
Estimated Study Completion Date : 2026-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer

Location Details

NCT06405828

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How to Participate

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Locations

RECRUITING

United States, New York

Mount Sinai Hospital

New York, New York, United States, 10029