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 1. To evaluate the benefit of the systematic, formalized and joint intervention of a palliative care team and a chest physician team on: * Mood and depression * Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives regarding end-of-life * Respiratory symptoms (cough and 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. 2. Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
Centre Hospitalier Robert Ballanger
Aulnay-sous-Bois, France
NOT_YET_RECRUITINGHôpital Avicenne
Bobigny, France
RECRUITINGCentre Hospitalier de Versailles Andre Mignot
Le Chesnay, France
NOT_YET_RECRUITINGHôpital LOUIS PRADEL
Lyon, France
RECRUITINGHôpital NORD
Marseille, France
NOT_YET_RECRUITINGHôpital MARC JACQUET
Melun, France
RECRUITINGHôpital GEORGES POMPIDOU (HEGP)
Paris, France
NOT_YET_RECRUITINGHôpital Tenon
Paris, France
NOT_YET_RECRUITINGHôpital Pontchaillou
Rennes, France
RECRUITINGHôpital DELAFONTAINE
Saint-Denis, France
NOT_YET_RECRUITING...and 1 more locations
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.