Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer (ACCESS)

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer; Stage IV Breast Cancer AJCC V7
• Intervention / Treatment: Behavioral: ACCESS Supportive Care; Behavioral: Phone sessions

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.

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• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Mazor; Phone Number: (510) 418-8642; Email: melissa.mazor@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Melissa Mazor
      • Contact: Karisma Pantaleon; Phone Number: 212-824-7986.; Email: karisma.pantaleon2@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACCESS Supportive Care; Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care	Behavioral: ACCESS Supportive Care; ACCESS Supportive Care includes: Coaching sessions: 6 one-hour weekly Community Navigator led supportive and early palliative care health coaching sessions. Sessions will be hybrid (in-person or virtual) per participant preference.; Monthly check-in: Monthly check-ins (~5-10 minutes) about their supportive care and social determinants of health needs over 16 weeks.; Scheduling of outpatient supportive oncology appointment if interested.; Community linkage: Warm hand offs and connection to community resources to enhance access to support groups, educational workshops, and healthy lifestyle services.
Placebo Comparator: Attention Control; Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC .	Behavioral: Phone sessions; 6 weekly phone sessions, approximately 10 minutes in length each, to review breast cancer and supportive and palliative care resources in NYC and online. The 6 weekly phone sessions will include the topics discussed in the intervention arm but will be informational in nature. The phone sessions will be followed by monthly check-ins (~5 minutes) to review and answer questions about the resources for the duration of 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants recruited	Acceptability evaluates if patients accept the intervention through the ability to recruit 60 participants in 1.5 years and a <20% dropout rate at 9 months	at 9 months
Number of participants remaining in study	Acceptability evaluates if patients accept the intervention through a <20% dropout rate at 9 months	at 9 months
Number of times navigator communicates with oncology team	Integration evaluates if the navigator can communicate with the supportive oncology and medical oncology team at least 80% of the time.	9 months
Number of times participants connect to resources	Integration evaluates if at least 80% of patients can connect to community and clinical resources.	9 months
Number of visits	Practicality evaluates if the navigator is able to deliver the intervention in person or virtual. Successful practicality benchmarks include > 80% of the visits conducted.	6 months
Number of phone calls	Practicality evaluates if the navigator is able to deliver the intervention in person or virtual. Successful practicality benchmarks include >80% of follow up phone calls conducted.	9 months
Number of visits conducted according to the ACCESS manual	Fidelity: This is indicated if >80% of the visits are conducted according to the ACCESS manual.	9 months
Change in The Impact of Event Scale - Revised (IES-R) scores	Cancer-related distress will be measured through the Impact of Event Scale - Revised (IES-R) is a 22-item instrument to assess distress. Each item is scored 0-4, with full scale from 0-22. Higher scores indicate greater severity of symptoms related to distress. Efficacy assessed by mean differences at 9 months as compared to baseline.	Baseline and 9 months
Change in The Memorial Symptom Assessment Scale (MSAS)	Symptom Burden will be measured through the Memorial Symptom Assessment (MSAS) is a 32 item instrument. Each item is scored from 0 to 4 with full scale from 0-128. A higher score indicates a greater level of symptom distress.	Baseline and 9 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Melissa Mazor, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: May 4, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Study-21-01250; K08CA267309 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism Following publication and any de-identified data and supportive documents can be requested from melissa.mazor@mountsinai.org
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No