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Trial Title:
Enhancing Access to Supportive Services for Women of Color with Metastatic Breast Cancer
NCT ID:
NCT06405828
Condition:
Metastatic Breast Cancer
Stage IV Breast Cancer AJCC V7
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
ACCESS Supportive Care
Description:
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.
Arm group label:
ACCESS Supportive Care
Intervention type:
Behavioral
Intervention name:
Phone sessions
Description:
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.
Arm group label:
Attention Control
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.
Detailed description:
Primary Objectives:
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.
.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
self-identify as a woman
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mount Sinai Hospital
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karisma Pantaleon
Phone:
212-824-7986.
Email:
karisma.pantaleon2@mountsinai.org
Contact backup:
Last name:
Melissa Mazor
Start date:
May 1, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Icahn School of Medicine at Mount Sinai
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Icahn School of Medicine at Mount Sinai
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06405828
