Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 20
- 主要终点
- Change in level of EORTC QLQ-C15-PAL
研究概览
简要总结
This study verifies whether integrated Early Palliative Care for advanced cancer patients diagnosed due to a solid tumor improve quality of life and enhances the ability to overcome the current crisis.
详细描述
Previous reports suggest that starting palliative care early in cancer patients appears to improve patient's quality of life, symptom management, depression, and anxiety.
This study aims to evaluate the effect of the introduction of early palliative care services to advanced cancer patients. Eligible patients are 20 years or older, and has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor, a European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months or less. The primary goal of an integrated early palliative care program is to improve the overall quality of life of patients and their families. Secondarily, it is to help understand the disease, resolving conflicts in the decision-making process, improving the crisis coping capacity, and further determining the patient's and family's advanced care planning. At last, it is desired to evaluate the effect of the program on overall medical cost savings and 1 year survival.
Participants of the study will be allocated in the intervention group and the control group equally. Within three weeks from the time of randomization, the first meeting with a palliative care team will be held. In the time of baseline questionnaire, patients will be provided with self-study education materials and videos on the early palliative care and advance care planning. Once in every three weeks for six months, which is the duration for one treatment course, palliative care for advance care planning, symptom control, and other mental, social and spiritual problems will be provided. After the first meeting with the palliative care team, telephone coaching will be performed once a week for the first 12 weeks and then every two weeks until the end of the study.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject 20 years and older.
- •Subject who has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor
- •Subject whose ECOG performance status is between 0 to
- •Subject with an estimated life expectancy of 12 months and less (assessed by the treating oncologist)
- •Subject who volunteers
排除标准
- •Inability to speak, understand or write Korean.
- •Medical conditions that would limit adherence to participation of the clinical trial(as confirmed by their referring physician; e.g. dyspnea)
- •Suspension of all cancer treatment
- •Palliative care consultation at any time or in palliative care
结局指标
主要结局
Change in level of EORTC QLQ-C15-PAL
时间窗: baseline, 12 weeks, 18 weeks, 24 weeks
A questionnaire developed to assess the quality of life of palliative cancer care patients.
次要结局
- Change in level of MQOL(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Change in level of EQ-5D of EuroQoL(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Change in level of PHQ-9(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Change in level of Understanding the illness(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Change in level of Crisis Overcoming Capability(SAT-SF)(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Change in level of PHQ-9 of family caregivers(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Change in level of Crisis Overcoming Capability(SAT-SF) of family caregivers(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Change in Advance Care Preference of family caregivers(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Change in Quality Care Questionnaire(Baseline, 12 weeks, 3 months after death)
- Change in Advance Care Preference(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Changes of CQOL(Baseline, 12 weeks, 18 weeks, 24 weeks)
- Medical cost and utilization of CAM(12 weeks, 24 weeks)
- 1 year survival(1 year)
- Change in level of Understanding the illness of family caregivers(Baseline, 12 weeks, 18 weeks, 24 weeks)
研究者
Young Ho Yun
Principal Investigator
Seoul National University Hospital