Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer
NCT ID: NCT06405828
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
67 participants
INTERVENTIONAL
2024-05-01
2026-11-30
Brief Summary
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Detailed Description
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1. Establish the feasibility and acceptability of an adapted navigator delivered supportive care model called ACCESS to address supportive care needs for Black and Latina women with Metastatic Breast Cancer.
2. Determine the potential impact of ACCESS on cancer related distress, symptom burden, and utilization of supportive care services.
OUTLINE: Participants (N=60) are randomized to 1 of 2 groups:
GROUP 1/Intervention Group: Participants complete 6 individualized behavioral/educational sessions focused on social determinants of health and supportive care with a trained community navigator followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 and 9 months.
GROUP 2/Attention Control group: Participants complete 6 phone calls with a research coordinator focused on supportive care resources followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 months and 9 months.
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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ACCESS Supportive Care
Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care
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.
Attention Control
Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC .
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* receiving inpatient hospice care
* if patients were previously enrolled in Aim 1 and Aim 2
* currently working with a community navigator
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Melissa Mazor
Assistant Professor
Principal Investigators
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Melissa Mazor
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai Hospital
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Study-21-01250
Identifier Type: -
Identifier Source: org_study_id
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