An interventional study of Supportive care in Idiopathic Pulmonary Fibrosis, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 11 sites in France. Open to participants aged 41 Years and older. Per ClinicalTrials.gov, last updated 2018-01-26.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care
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.
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).
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.
Objective:
To investigate the benefit on quality of life, evaluated after 6 months, of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team compared to standard care for patients with severe IPF.
Secondary endpoints
To evaluate the benefit of the systematic, formalized and joint intervention of a palliative care team and a chest physician team on:
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
Other: Supportive care
pneumological consultation performed at M0, M3 and M6
supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
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.
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
Time frame: at 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
evaluated by the Hospital Anxiety and Depression questionnaire. * Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives * Respiratory symptoms (dyspnea) * The course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations). * Overall survival and place of death.
Time frame: 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.
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 will be evaluated by the illness understanding questionnaire.
Time frame: 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)
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea) will be evaluated by St George's respiratory questionnaire (SGRQ) and Transition Dyspnea Index (TDI)
Time frame: 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 course of care.
the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations)
Time frame: 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.
the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival measured between inclusion and date of death or last news.
Time frame: 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)
This outcome is evaluated by the medico-economic questionnaire : EuroQol five dimensions questionnaire (EQ-5D)
Time frame: at 3 and 6 months after inclusion
Plan to share: No
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Assistance Publique - Hôpitaux de Paris