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

NCT03229343 | Unknown

• 1 other identifier: P150965
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 11

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

idiopathic pulmonary fibrosis, palliative care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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)

Study Arms (2)

Experimental

EXPERIMENTAL

Supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.

Other: Supportive care

standard

NO INTERVENTION

pneumological consultation performed at M0, M3 and M6

Interventions

Supportive care OTHER

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

Experimental

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (11)

Centre Hospitalier Robert Ballanger

Aulnay-sous-Bois, 93602, France

NOT YET RECRUITING

Hôpital Avicenne

Bobigny, 93000, France

RECRUITING

Centre Hospitalier de Versailles Andre Mignot

Le Chesnay, 78150, France

NOT YET RECRUITING

Hôpital LOUIS PRADEL

Lyon, 69677, France

RECRUITING

Hôpital NORD

Marseille, 13015, France

NOT YET RECRUITING

Hôpital MARC JACQUET

Melun, France

RECRUITING

Hôpital GEORGES POMPIDOU (HEGP)

Paris, 75015, France

NOT YET RECRUITING

Hôpital Tenon

Paris, 75020, France

NOT YET RECRUITING

Hôpital Pontchaillou

Rennes, 35033, France

RECRUITING

Hôpital DELAFONTAINE

Saint-Denis, 93200, France

NOT YET RECRUITING

Hôpital LARREY

Toulouse, 31059, France

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 19815403 BACKGROUND

• 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.

  PMID: 15994268 BACKGROUND

• 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.

  PMID: 20818875 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Boris Duchemann

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris Duchemann, Dr

CONTACT

01 48 95 50 32; boris.duchemann@aphp.fr

Nacira DARGHAL, PhD

CONTACT

01 48 95 74 73; nacira.darghal@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 25, 2017
• Study Start: December 4, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: January 26, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)