Randomized Controlled Trial of Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Quality of life score (FACT-L Total Score)
研究概览
简要总结
Early palliative care has been shown to improve the survival of advanced lung cancer patients. However, most of the clinical studies were performed in the era when systemic treatment options for this disease were limited. Currently, many effective treatment options are available, including targeted therapy and immunotherapy. These novel agents improve the treatment outcomes while having less toxicity compared to conventional chemotherapy. Moreover, medical oncologists are now trained to provide palliative care for patients. This study was designed to demonstrate whether early palliative care provided by the palliative care specialist still improves the quality of life or survival of advanced lung cancer patients compared to standard care provided by the medical oncologist.
详细描述
Advanced non-small cell lung cancer patients initiating a systemic treatment will be randomized to the early palliative care arm (attending a palliative care clinic once a month during the first three months concurrently with oncology clinic appointment) or the standard care arm (attending oncology clinic only). The patients will be asked to complete the quality of life questionnaires (FACT-L, EQ-5D-5L), mental health questionnaire (PHQ-9), and pain assessment once a month for three months and at the sixth month.
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
- •Age at least 18 years old
- •Pathologically confirmed advanced non-small cell lung cancer
- •Plan to receive systemic treatment for lung cancer within three weeks
- •ECOG performance status 0-2 with estimated life expectancy > 24 weeks
- •Having at least 4 scores according to Edmonton Symptom Assessment System (ESAS)
- •Able to complete the questionnaires
排除标准
- •Had received systemic treatment for advanced lung cancer before
研究组 & 干预措施
Early palliative care with standard care
The patients will attend palliative care clinic once a month during the first three months together with oncology clinic visits
干预措施: Early palliative care integration (Other)
Early palliative care with standard care
The patients will attend palliative care clinic once a month during the first three months together with oncology clinic visits
干预措施: Standard systemic treatment for advanced lung cancer (Drug)
Standard care
The patients will attend oncology clinic as usual
干预措施: Standard systemic treatment for advanced lung cancer (Drug)
结局指标
主要结局
Quality of life score (FACT-L Total Score)
时间窗: 12 weeks after treatment
The patients were asked to assess their Health-related Quality Of Life (HRQoL) using FACT-L (Functional Assessment of Cancer Therapy - Lung) questionnaire. The score ranges from 0-136 with higher score indicating better HRQoL.
次要结局
- Change in quality of life (FACT-L Total Scores)(12 and 24 weeks after treatment)
- Change in mental health score (PHQ-9)(12 and 24 weeks after treatment)
- Change in pain score(12 and 24 weeks after treatment)
- One-year survival rate(One year after treatment)
- Two-year survival rate(Two years after treatment)
- Proportion of patients who have advanced care plan(six months)
- Change in utility score measured by EQ-5D-5L questionnaire(12 and 24 weeks after treatment)