Recruiting

Supportive Care

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06405828

Conditions

Metastatic Breast Cancer

Stage IV Breast Cancer AJCC V7

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACCESS Supportive Care

Phone sessions

Study Details

Brief 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.

Conditions

Metastatic Breast Cancer

Stage IV Breast Cancer AJCC V7

Study ID

NCT06405828

Start date

May 1, 2024

Status verified date

Oct, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

67 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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 .

Interventions

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.

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 measure

  • Number of participants recruited [ Time Frame: at 9 months ]
  • Number of participants remaining in study [ Time Frame: at 9 months ]
  • Number of times navigator communicates with oncology team [ Time Frame: 9 months ]
  • Number of times participants connect to resources [ Time Frame: 9 months ]
  • Number of visits [ Time Frame: 6 months ]
  • Number of phone calls [ Time Frame: 9 months ]
  • Number of visits conducted according to the ACCESS manual [ Time Frame: 9 months ]
  • Change in The Impact of Event Scale - Revised (IES-R) scores [ Time Frame: Baseline and 9 months ]
  • Change in The Memorial Symptom Assessment Scale (MSAS) [ Time Frame: Baseline and 9 months ]

Central Contacts and Locations

Central contacts

Melissa Mazor

(510) 418-8642melissa.mazor@mountsinai.org

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Karisma Pantaleon

212-824-7986.karisma.pantaleon2@mountsinai.org

Principal Investigator:

Melissa Mazor

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Nov 5, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-11-05.