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

Mount Sinai Health System

Status: Enrolling

Conditions: Stage IV Breast Cancer AJCC V7; Metastatic Breast Cancer

Treatments: Behavioral: Phone sessions; Behavioral: ACCESS Supportive Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06405828

Study-21-01250

K08CA267309 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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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Enrollment: 67 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

ACCESS Supportive Care

Experimental group

Description:

Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care

Treatment:

Behavioral: ACCESS Supportive Care

Attention Control

Placebo Comparator group

Description:

Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC .

Treatment:

Behavioral: Phone sessions