Project ACCESS: A Pilot Randomized Controlled Trial of a Navigator Delivered Model to Enhance Access to Supportive Services for Women of Color With Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Number of phone calls
研究概览
简要总结
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.
详细描述
Primary Objectives:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of phone calls
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 9 months
Fidelity: This is indicated if \>80% of the visits are conducted according to the ACCESS manual.
Number of participants recruited
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Melissa Mazor
Assistant Professor
Icahn School of Medicine at Mount Sinai