Clinical trial NCT06405828: Enhancing Access to Supportive Services for Women of Color 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Stage IV Breast Cancer AJCC V7
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-05-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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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Eligibility 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

Primary outcomes:
measure: Number of participants recruited
timeFrame: at 9 months
measure: Number of participants remaining in study
timeFrame: at 9 months
measure: Number of times navigator communicates with oncology team
timeFrame: 9 months
measure: Number of times participants connect to resources
timeFrame: 9 months
measure: Number of visits
timeFrame: 6 months
measure: Number of phone calls
timeFrame: 9 months
measure: Number of visits conducted according to the ACCESS manual
timeFrame: 9 months
measure: Change in The Impact of Event Scale - Revised (IES-R) scores
timeFrame: Baseline and 9 months
measure: Change in The Memorial Symptom Assessment Scale (MSAS)
timeFrame: Baseline and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Melissa Mazor
role: PRINCIPAL_INVESTIGATOR
References: