Randomized Trial of a Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Documentation of End-of-Life Care Preferences
研究概览
简要总结
Many people living with metastatic breast cancer face challenging symptoms and frequent medical visits. At the same time, conversations about personal goals, values, and preferences for care may not always happen as early or as often as patients and families would like. This multi-site study will test the effectiveness of a five-session palliative care program, designed specifically for people with metastatic breast cancer and their caregivers, to strengthen communication with clinicians about what matters most in their care. The study aims to inform how palliative care services can be delivered in a more timely, personalized, and scalable way for people living with advanced cancers who have long disease trajectories, such as metastatic breast cancer.
详细描述
The diagnosis of metastatic breast cancer can bring many challenges including physical symptoms, treatment side effects, and emotional stress for patients and their families. Palliative care specialists work alongside the oncology team to help patients and families manage symptoms, communicate effectively with their clinicians, and cope with the impact of living with cancer.
Research has shown that when palliative care and oncology teams collaborate closely, patients often experience better symptom relief, clearer communication about their goals and preferences, improved quality of life and mood, and a stronger understanding of their illness. Caregivers also report feeling more supported and less distressed.
The purpose of this research study is to learn whether a personalized palliative care program for people with metastatic breast cancer and their caregivers, called TARGET-PC, can further improve communication, symptom management, coping skills, and understanding of care.
In this study, 400 patients with metastatic breast cancer and their caregivers will be randomly assigned to receive either the TARGET-PC program or enhanced usual care. Enhanced usual care includes an electronic prompt that reminds oncology clinicians to discuss and record each patient's goals and preferences for care. The study will take place at the Massachusetts General Hospital Cancer Center, Penn Abramson Cancer Center, and Duke Cancer Center.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •age ≥18 years
- •diagnosed with metastatic breast cancer
- •within 8 weeks of the oncology visit at which they were identified as having an eligible Epic EOL Care Index (≥ 15)
- •functioning independently per an Eastern Cooperative Oncology Group performance status ≤2
- •receiving their cancer care at one of the participating institutions
- •able to complete questionnaires in English or Spanish
排除标准
- •received outpatient palliative care visit within the last six months
- •enrolled in hospice services
- •diagnosed with a comorbid condition that impairs their ability to understand study procedures and/or consent for the trial as per the report of the oncology clinician(s)
- •Caregiver Inclusion Criteria:
- •age ≥18 years
- •identified by the patient as a family member or friend who is primarily involved in their care
- •able to complete questionnaires in English or Spanish
研究组 & 干预措施
Palliative Care Intervention, "TARGET-PC"
Patients randomly assigned to TARGET-PC will receive the palliative care intervention in addition to usual oncology care. Palliative care intervention visits will be conducted by a palliative care physician or advanced practice provider either in-person or with hospital-approved videoconference technology. Patients will be scheduled for their first palliative care visit within four weeks of randomization. Subsequent palliative care intervention visits will be scheduled every four weeks until the patient completes visit five. If a patient cannot be scheduled for intervention visits within four weeks, the palliative care clinician will contact them via telephone within four weeks of their prior contact to maintain their relationship and rapport. Palliative care clinicians will be permitted to conduct an intervention visit over the phone or video if they feel it is appropriate based on the patient's health status.
干预措施: Palliative Care Intervention, "TARGET-PC" (Other)
Enhanced Usual Care
The oncology clinicians (physicians and advanced practice providers) of patients randomly assigned to the enhanced usual care condition will receive electronic prompts, encouraging them to discuss and document their patient's care preferences for up to five months after the patient is randomized. The prompts will be sent electronically. The research assistant will send the first electronic prompt on the morning of the outpatient oncology appointment immediately following the visit at which the patient provided informed consent for the study. Subsequent electronic prompts will be sent on the morning of outpatient oncology appointments for five months, but no more often than every four weeks.
干预措施: Enhanced Usual Care (Other)
结局指标
主要结局
Documentation of End-of-Life Care Preferences
时间窗: From date of randomization until date of death or last follow up assessed up to 60 months
To compare proportions of patients with clinician-documented end-of-life care preferences in the electronic health record by last follow-up time point or date of death between study groups.
次要结局
- Death in the Hospital(From date of randomization until date of death or last follow up assessed up to 60 months)
- Hospice Utilization(From date of randomization until date of death or last follow up assessed up to 60 months)
- Patient-reported Communication about End-of-Life Care Preferences(From date of randomization until date of death or last follow up assessed up to 60 months)
- Hospice Length of Stay(From date of randomization until date of death or last follow up assessed up to 60 months)
研究者
Jennifer Temel, MD
Co-Principal Investigator
Massachusetts General Hospital