Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis. (PALIF)

Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis (IPF). A Randomized Multi-center Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: Supportive care

Detailed Description

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
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boris Duchemann, Dr; Phone Number: 01 48 95 50 32; Email: boris.duchemann@aphp.fr
• Study Contact Backup: Name: Nacira DARGHAL, PhD; Phone Number: 01 48 95 74 73; Email: nacira.darghal@aphp.fr

Study Locations

• France
  • Aulnay-sous-Bois, France, 93602
    • Not yet recruiting
    • Centre Hospitalier Robert Ballanger
    • Contact: Jérome VIRALLY, Pr
  • Bobigny, France, 93000
    • Recruiting
    • Hôpital Avicenne
    • Contact: Boris DUCHEMANN, PI
  • Le Chesnay, France, 78150
    • Not yet recruiting
    • Centre Hospitalier de Versailles André Mignot
    • Contact: Nathalie MICHENOT, Dr
  • Lyon, France, 69677
    • Recruiting
    • Hopital Louis Pradel
    • Contact: Vicent COTTIN, Pr
  • Marseille, France, 13015
    • Not yet recruiting
    • Hôpital Nord
    • Contact: Martine REYNAUD GAUBERT, Pr
  • Melun, France
    • Recruiting
    • Hopital Marc Jacquet
    • Contact: Djamel BENNEGADI, Dr
  • Paris, France, 75020
    • Not yet recruiting
    • Hôpital Tenon
    • Contact: Jean Marc NACCACHE, Pr
  • Paris, France, 75015
    • Not yet recruiting
    • Hôpital GEORGES POMPIDOU (HEGP)
    • Contact: Dominique ISRAEL-BIET, Pr
  • Rennes, France, 35033
    • Recruiting
    • Hôpital Pontchaillou
    • Contact: Stéphane JOUNEAU, Pr
  • Saint-Denis, France, 93200
    • Not yet recruiting
    • Hôpital Delafontaine
    • Contact: Isabelle LERAT, Dr
  • Toulouse, France, 31059
    • Not yet recruiting
    • Hôpital Larrey
    • Contact: Grégoire PREVOT, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.	Other: Supportive care; supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
No Intervention: standard; pneumological consultation performed at M0, M3 and M6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 6 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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)	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.	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)	at 3 and 6 months after inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Boris Duchemann, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
• Swigris JJ, Brown KK, Behr J, du Bois RM, King TE, Raghu G, Wamboldt FS. The SF-36 and SGRQ: validity and first look at minimum important differences in IPF. Respir Med. 2010 Feb;104(2):296-304. doi: 10.1016/j.rmed.2009.09.006. Epub 2009 Oct 7.
• Swigris JJ, Kuschner WG, Jacobs SS, Wilson SR, Gould MK. Health-related quality of life in patients with idiopathic pulmonary fibrosis: a systematic review. Thorax. 2005 Jul;60(7):588-94. doi: 10.1136/thx.2004.035220.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: idiopathic pulmonary fibrosis, palliative care
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: P150965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No