Randomized Trial of Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 507
- 试验地点
- 3
- 主要终点
- Patient-reported Quality of Life
研究概览
简要总结
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer
详细描述
Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. In addition, both patients and their loved ones (family and friends) often feel worried or sad about their cancer diagnosis.
Research has shown that early involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer. This team is called "palliative care," and consists of physicians and advanced practice nurses (or "nurse practitioners") who work closely and collaboratively with your oncology team to care for the participant and the participant's loved ones. Research shows that when the palliative care team works closely with the oncology team to care for patients with advanced cancer, they may have better symptom control, quality of life, and mood and their loved ones feel less distressed.
This study will compare two different strategies for scheduling participant's visits with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month. The investigators call this strategy "early integrated palliative care".
The second strategy is to schedule the participant to meet with the palliative care clinician after the participant is admitted to the hospital or if the participant's oncology team needs to change the participant cancer treatment, as these are times when the participant is likely to have health issues that the palliative care clinician can help with. The investigators will also monitor the participant's quality of life regularly. If the study team determines that the participant quality of life worsens, the investigators will increase the frequency of the participant's visits with the palliative care clinician to monthly appointments. The investigators call this strategy "stepped palliative care" because the investigators step up the frequency of the participant palliative care visits if the participant's quality of life worsens during the participant cancer treatment.
No matter which strategy the participant is taking part in, the participant will still be able to request additional palliative care visits outside of the study schedule if the participant feel they need them.
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
- None
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
- •Diagnosed with advanced non-small cell lung cancer, small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior twelve weeks
- •Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed <50% of the day)
- •The ability to read and respond to questions in English or Spanish
- •Primary cancer care at one of the three participating sites
- •Age > 18 years
排除标准
- •Already receiving outpatient PC or hospice services
- •Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
研究组 & 干预措施
Early Integrated PC
- Patients will receive Early Integrated PC
- Patients will meet with the PC clinician within four weeks of enrollment and at least every four weeks throughout their course of illness
干预措施: Early Integrated PC (Other)
Stepped PC
- Patients will receive Stepped PC
- During step 1, patients will be scheduled to meet with the outpatient PC clinician within four weeks of study enrollment and after they are admitted to the hospital or have a change in their cancer treatment
- Patients will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) to monitor their quality of life every six weeks and if their quality of life deteriorates substantially, they will "step up" to step 2 of the protocol
- Patients who transition to step 2 will then meet with the PC clinician at least every four weeks for the remainder of their illness
干预措施: Stepped PC (Other)
结局指标
主要结局
Patient-reported Quality of Life
时间窗: 24 Weeks
Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung Range 0-136 with higher scores indicating better quality of life
次要结局
- Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians(48 weeks (or last assessment prior to death if before 48 weeks))
- Palliative Care Resource Utilization(week 24)
- Length of Stay in Hospice(From hospice enrollment until death during study period (i.e. 12-month follow up))
研究者
Jennifer Temel, MD
Principal Investigator
Massachusetts General Hospital