Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis (IPF). A Randomized Multi-center Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 21
- 主要终点
- The benefit of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team on quality of life, evaluated after 6 months by the Short Form (36) Health Survey.
研究概览
简要总结
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life.
In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients.
In the princeps study published in 2010, the early intervention of a dedicated palliative care team was compared to standard care in a randomized trial of 150 patients and shows a significant improvement : (i) of quality of life (main objective), (ii) of depression scores and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted hospitalization in end of life (in emergency or not).
Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory symptom, psychological burden), it seemed reasonable to assume that the joint systematic intervention of chest physician and palliative care team may provide a significant benefit in terms of quality of life for patients with severe IPF.
详细描述
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life. This alteration results from different consequences of the IPF: progressive shortness of breath, irritative cough refractory to treatments, exhaustion, limitation of activity, social isolation, and psychic consequences such as fear, anxiety and depression.
The only current curative treatment of the disease is pulmonary transplantation, but it's only feasible for a minority of patients. Anti-fibrotic drugs, such as pirfenidone and nintedanib, are likely to slow the progression of IPF but have no impact on patients' quality of life.
The symptomatic treatment aimed at relieving respiratory discomfort and the patient's quality of life is therefore fundamental, and the IPF meets in many ways the challenges of lung cancer.
In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients.
In the princeps study published in 2010, the early intervention of a dedicated palliative care team was compared to standard care in a randomized trial of 150 patients and shows a significant improvement : (i) of quality of life (main objective), (ii) of depression scores and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted hospitalization in end of life (in emergency or not).
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
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 40 years
- •Patient with confirmed diagnosis of IPF according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT) criteria. The patient may be included regardless of the date of diagnosis.
- •Advanced IPF with Forced Vital Capacity (FVC) <50%" of predicted value and / or Diffusing capacity for carbon monoxide ((DLCO) <30% of predicted value or inability to achieve the Functional Respiratory Investigations (EFR) due to respiratory severity. EFR dated less than 3 months.
- •Absence of argument for acute or subacute exacerbation in the last 6 months.
- •Patient who can be followed in ambulatory consultation/ outpatient consultation.
- •Informed consent signed (signed by the patient or in the presence of a third party for patients who are poorly fluent in French).
- •Affiliation to the social security system.
排除标准
- •Patient unable to respond to quality of life questionnaires.
- •Inability (physical or mental) to give a written informed consent.
- •Acute exacerbation of fibrosis in the previous 6 months.
- •Patient eligible for a pulmonary transplant.
- •Participation in other therapeutic trial
- •Patient cannot be followed in ambulatory consultation.
- •Patient under trustee
研究组 & 干预措施
Experimental
Supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
干预措施: Supportive care (Other)
standard
pneumological consultation performed at M0, M3 and M6
结局指标
主要结局
The benefit of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team on quality of life, evaluated after 6 months by the Short Form (36) Health Survey.
时间窗: at 6 months after inclusion
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The Short Form (36) Health Survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. This score has already been used for IPF
次要结局
- The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care.(at 3 and 6 months after inclusion)
- The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival.(between inclusion and date of death or last news. (survival follow-up visit at month 12))
- Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion)(at 3 and 6 months after inclusion)
- The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Mood and depression(at 3 and 6 months after inclusion)
- The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives.(at 3 and 6 months after inclusion)
- The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea)(at 3 and 6 months after inclusion)