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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06405828
Other study ID # Study-21-01250
Secondary ID K08CA267309
Status Recruiting
Phase N/A
First received
Last updated
Start date May 9, 2024
Est. completion date January 2025

Study information

Verified date June 2024
Source Icahn School of Medicine at Mount Sinai
Contact Melissa Mazor
Phone (510) 418-8642
Email melissa.mazor@mountsinai.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. .


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 - Metastatic breast cancer (MBC) diagnosis in past 5 years 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


Related Conditions & MeSH terms


Intervention

Behavioral:
ACCESS Supportive Care
ACCESS Supportive Care includes: 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. Monthly check-in: Monthly check-ins (~5-10 minutes) about their supportive care and social determinants of health needs over 16 weeks. Scheduling of outpatient supportive oncology appointment if interested. 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.

Locations

Country Name City State
United States Mount Sinai Hospital New York New York

Sponsors (2)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants recruited 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 at 9 months
Primary Number of participants remaining in study Acceptability evaluates if patients accept the intervention through a <20% dropout rate at 9 months at 9 months
Primary Number of times navigator communicates with oncology team Integration evaluates if the navigator can communicate with the supportive oncology and medical oncology team at least 80% of the time. 9 months
Primary Number of times participants connect to resources Integration evaluates if at least 80% of patients can connect to community and clinical resources. 9 months
Primary Number of visits Practicality evaluates if the navigator is able to deliver the intervention in person or virtual. Successful practicality benchmarks include > 80% of the visits conducted. 6 months
Primary Number of phone calls 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. 9 months
Primary Number of visits conducted according to the ACCESS manual Fidelity: This is indicated if >80% of the visits are conducted according to the ACCESS manual. 9 months
Primary Change in The Impact of Event Scale - Revised (IES-R) scores 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.
Baseline and 9 months
Primary Change in The Memorial Symptom Assessment Scale (MSAS) 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. Baseline and 9 months
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