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

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ClinicalTrials.gov Identifier: NCT03229343
Recruitment Status : Unknown
Verified July 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : July 25, 2017
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 4, 2017
First Posted Date  ICMJE July 25, 2017
Last Update Posted Date January 26, 2018
Actual Study Start Date  ICMJE December 4, 2017
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
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. [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • 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 [ Time Frame: at 3 and 6 months after inclusion ]
    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.
  • 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. [ 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 will be evaluated by the illness understanding questionnaire.
  • The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea) [ 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) will be evaluated by St George's respiratory questionnaire (SGRQ) and Transition Dyspnea Index (TDI)
  • The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care. [ 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 use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations)
  • The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival. [ Time Frame: between inclusion and date of death or last news. (survival follow-up visit at month 12) ]
    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.
  • Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion) [ Time Frame: at 3 and 6 months after inclusion ]
    This outcome is evaluated by the medico-economic questionnaire : EuroQol five dimensions questionnaire (EQ-5D)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis.
Official Title  ICMJE Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis (IPF). A Randomized Multi-center Trial.
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Experimental arm : supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.

Non interventionnel arm: only pneumological consultation performed at M0, M3 and M6.

Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE Other: Supportive care
supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
Study Arms  ICMJE
  • Experimental: Experimental
    Supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
    Intervention: Other: Supportive care
  • No Intervention: standard
    pneumological consultation performed at M0, M3 and M6
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 24, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 41 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03229343
Other Study ID Numbers  ICMJE P150965
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Boris Duchemann Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP