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

Metastatic Breast Cancer Clinical Trial

— ACCESS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06405828
• Other study ID #: Study-21-01250
• Secondary ID: K08CA267309
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2024
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Melissa Mazor
• Phone: (510) 418-8642
• Email: melissa.mazor[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

• Metastatic breast cancer (MBC) diagnosis in past 5 years

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants remaining in study	Acceptability evaluates if patients accept the intervention through a <20% dropout rate at 9 months	at 9 months
Primary	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
Primary	Number of times participants connect to resources	Integration evaluates if at least 80% of patients can connect to community and clinical resources.	9 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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