NCT06405828 · Icahn School of Medicine at Mount Sinai
Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer
(ACCESS)
What this study is 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.
View original scientific description
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.
Interventions
BEHAVIORAL
ACCESS Supportive Care
ACCESS Supportive Care includes: 1. 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. 2. Monthly check-in: Monthly check-ins (\~5-10 minutes) about their supportive care and social determinants of health needs over 16 weeks. 3. Scheduling of outpatient supportive oncology appointment if interested. 4. Community linkage: Warm hand offs and connection to community resources to enhance access to support groups, educational workshops, and healthy lifestyle services.
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.
Primary outcome measures
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 5, 2025 · Source of record for eligibility and locations