Mount Sinai Hospital
New York, 10029, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06405828
Enhancing 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Primary Objectives:
- 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.
- 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.
.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
ACCESS Supportive Care
BehavioralACCESS 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
Behavioral6 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.
Primary outcomes
-
Number of participants recruited
Time frame: at 9 months
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
-
Number of participants remaining in study
Time frame: at 9 months
Acceptability evaluates if patients accept the intervention through a <20% dropout rate at 9 months
-
Number of times navigator communicates with oncology team
Time frame: 9 months
Integration evaluates if the navigator can communicate with the supportive oncology and medical oncology team at least 80% of the time.
-
Number of times participants connect to resources
Time frame: 9 months
Integration evaluates if at least 80% of patients can connect to community and clinical resources.
-
Number of visits
Time frame: 6 months
Practicality evaluates if the navigator is able to deliver the intervention in person or virtual. Successful practicality benchmarks include > 80% of the visits conducted.
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Number of phone calls
Time frame: 9 months
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.
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Number of visits conducted according to the ACCESS manual
Time frame: 9 months
Fidelity: This is indicated if >80% of the visits are conducted according to the ACCESS manual.
-
Change in The Impact of Event Scale - Revised (IES-R) scores
Time frame: Baseline and 9 months
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.
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Change in The Memorial Symptom Assessment Scale (MSAS)
Time frame: Baseline and 9 months
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study 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
Acronym: ACCESS
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 9, 2024
- Registry last updated
- Nov 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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