Enhancing Access to Supportive Services for Women of Color with Metastatic Breast Cancer
- Conditions
- Stage IV Breast Cancer AJCC V7Metastatic Breast Cancer
- Interventions
- Behavioral: Phone sessionsBehavioral: ACCESS Supportive Care
- Registration Number
- NCT06405828
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
- 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.
.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Attention Control Phone sessions Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC . ACCESS Supportive Care ACCESS Supportive Care Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care
- Primary Outcome Measures
Name Time Method Number of phone calls 9 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 participants remaining in study at 9 months Acceptability evaluates if patients accept the intervention through a \<20% dropout rate at 9 months
Number of times navigator communicates with oncology team 9 months Integration evaluates if the navigator can communicate with the supportive oncology and medical oncology team at least 80% of the time.
Number of visits conducted according to the ACCESS manual 9 months Fidelity: This is indicated if \>80% of the visits are conducted according to the ACCESS manual.
Number of participants recruited at 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 visits 6 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 times participants connect to resources 9 months Integration evaluates if at least 80% of patients can connect to community and clinical resources.
Change in The Impact of Event Scale - Revised (IES-R) scores Baseline 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇺🇸New York, New York, United States