RecruitingNot ApplicableNCT06405828

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

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

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

67 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer Stage IV Breast Cancer AJCC V7

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a program to help Latina and Black women living with Stage IV (metastatic) breast cancer access supportive services — such as mental health care, financial assistance, transportation, and other social support — through a community health navigator. **You may be eligible if...** - You are a woman 18 or older - You self-identify as Latina and/or African American/Black - You have a diagnosis of Stage IV breast cancer (metastatic, diagnosed at any time) - You speak English and/or Spanish **You may NOT be eligible if...** - You have moderate to severe cognitive impairment - You are currently receiving inpatient hospice care - You were previously enrolled in an earlier phase of this same study (Aims 1 or 2) - You are already working with a community health navigator Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALACCESS 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.

BEHAVIORALPhone 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(1)

Mount Sinai Hospital

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06405828

Related Trials

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

NCT05894239192 locations

Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread

NCT06324357108 locations

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

NCT0642839641 locations

Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer

NCT0545561910 locations

A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

NCT0734760017 locations