Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Quality of life evaluation: standardized questionnaire
研究概览
简要总结
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .
详细描述
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are over 70 years old
- •Patients from being diagnosed with acute myeloid leukemia and high-risk myelodysplastic syndrome or after the third line of therapy for high-grade lymphoma.
排除标准
- •All patients with a curative project (induction chemotherapy ou allogenic transplantation)
- •All patients in a terminal palliative status
- •Patients who don't speak French,
- •Patients not able to read and write
- •Patients who don't agree to participate in the protocol
- •Patients with psychiatric troubles or cognitive disorders
- •Patients under guardianship or curatorship, deprived of freedom or under justice protection.
研究组 & 干预措施
Conventional haematological care
Patients with haematological malignancy Conventional haematological care
干预措施: Early palliative care integration (Drug)
Conventional care associated with a monthly consultation
Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team
干预措施: Early palliative care integration (Drug)
结局指标
主要结局
Quality of life evaluation: standardized questionnaire
时间窗: at 6 months
Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being \[score range 0-28\], Social/Family Well-Being \[score range 0-28\], Emotional Well-Being \[score range 0-24\], and Functional Well-Being \[score range 0-28\] and specific questions concerning anemia \[score range 0-80\]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score \[score range 0-188\].
次要结局
- Presence of discomfort symptoms(at Day 0, 3 months, 6 months, 9 months, 12 months)
- overall survival(at day 1 : from the randomization until the date of death or until 1 year [study end].)
- Satisfaction of the care pathwaydesired by the patient(at 12 months or death)
- cost-effectiveness analysis(at 12 months or death)