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

This study is for Black and Latina women with metastatic breast cancer (cancer that has spread to other parts of the body). It aims to improve access to supportive care services, which can help with symptoms and quality of life. The study will test a program called ACCESS Supportive Care, which involves weekly coaching sessions with a community navigator. Another group will receive weekly phone sessions with information about resources. Researchers want to see if these programs are practical and helpful for participants. You can join if you are a woman over 18, speak English or Spanish, and have Stage IV breast cancer. The study plans to enroll 67 participants, but its current recruitment status is unclear.

Study design
This study is an interventional study that will randomize 60 participants into one of two groups to compare different supportive care approaches.
What's involved
If you join, you will either have 6 weekly coaching sessions with a community navigator or 6 weekly informational phone sessions, followed by monthly check-ins for 4 months. You will also complete questionnaires over the phone at the beginning, 6 months, and 9 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 9 months to measure recruitment, retention, and communication with the oncology team.

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NCT06405828

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

Recruiting
NAAges 18+InterventionalSupportive care
Icahn School of Medicine at Mount Sinai
~67 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:ACCESS Supportive CarePhone sessions

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants recruited
Measured over at 9 months
+8 more outcomes measured
Metastatic Breast Cancer
Stage IV Breast Cancer AJCC V7
1 sites across 1 states
New York1
  • Melissa Mazor · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

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

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
  • Number of participants recruitedat 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 studyat 9 months

    Acceptability evaluates if patients accept the intervention through a \<20% dropout rate at 9 months

  • Number of times navigator communicates with oncology team9 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 resources9 months

    Integration evaluates if at least 80% of patients can connect to community and clinical resources.

  • Number of visits6 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 calls9 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 manual9 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) scoresBaseline 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)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.