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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06405828
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ACCESS Supportive Care — BEHAVIORAL
    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.
  • Phone sessions — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
67 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: ACCESS Supportive Care
    Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care
  • Placebo Comparator: Attention Control
    Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC .

Primary Outcome Measure

Number of participants recruited [ Time Frame: at 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Karisma Pantaleon
[email protected]
212-824-7986.
Melissa Mazor (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mount Sinai Hospital· New York, NY

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