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Palliative Care in Pulmonary Fibrosis (PULFIP)

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ClinicalTrials.gov Identifier: NCT02929966
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief Summary:

The investigators will examine the effect of introducing palliative in patients with end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators will randomly assign patients who receive either early palliative care integrated with standard respiratory care or standard respiratory care alone.

Quality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome will be the change in the quality of life and symptoms at 12 months.


Condition or disease Intervention/treatment Phase
Idiophatic Pulmonary Fibrosis Other: palliative care program Other: standard respiratory care Not Applicable

Detailed Description:

Advanced fibrosing interstitial lung disease (ILD) is a group of often progressive and incurable conditions.

The most common form of ILD, idiopathic pulmonary fibrosis (IPF), is associated with poor survival, and high symptom burden and poor quality of life as the disease progresses.

ILD represents an increasing proportion of patients with chronic hypoxemic respiratory failure.

Despite this poor prognosis, palliative care remains underused in patients with ILD. This may be due to under-recognition of the palliative care needs and symptom burden, or unfamiliarity and discomfort with palliative therapies.

Though oncology has largely embraced earlier integration of palliative care, which has translated into improvements in end-of-life (EOL) care for patients with lung cancer,palliative and EOL care for non-malignant diseases are now gaining increased attention.

In pulmonary disease, this research has mainly focused on COPD and demonstrated a significant burden of unmet palliative care needs and lower quality of EOL care compared with patients with cancer. Similar attention is only beginning to be paid to ILD, but symptom burden and quality of EOL care in patients with ILD have yet to be quantified, and furthermore none has so far investigated the possible role of palliative care in these patients.

The investigators will examine with the present study the effect of introducing palliative in patients with end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators will randomly assign patients who receive either early palliative care integrated with standard respiratory care or standard respiratory care alone.

Quality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome will be the change in the quality of life and symptoms at 12 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Palliative Care in Patients With End Stage Pulmonary Fibrosis: a Randomized Control Study
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: standard respiratory care
The patients will receive the usual respiratory care that included both the "classical" treatments with antifibrotic drugs and oxygen therapy
Other: standard respiratory care
the usual standard pharmacological care plus oxygen therapy

Experimental: standard respiratory care PLUS a palliative care program
The patients will receive the usual respiratory care that included both the "classical" treatments with antifibrotic drugs and oxygen therapy PLUS a palliative care program that includes paid to assessing physical and psychosocial symptoms
Other: palliative care program
The program includes psychological support, spiritual care and respiratory therapist support




Primary Outcome Measures :
  1. quality of life [ Time Frame: 12 months ]
    Maugeri Respiratory Questionnaire reduced form

  2. depression [ Time Frame: 12 months ]
    Center for Epidemiologic Studies Depression score (C-ESDs)

  3. dyspnea score [ Time Frame: 12 months ]
    Borg scale


Secondary Outcome Measures :
  1. survival [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of idiophatic pulmonary fibrosis
  • resting partial arterial oxygen pressure (PaO2) < 60 mmHg
  • Decline in Forced Vital Capacity (FVC) > 10% in the last 6 months
  • stage 3 according to the GAP index

Exclusion Criteria:

  • active treatment with antifibrotic drug
  • concomitant cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929966


Contacts
Contact: stefano nava, md stefanava@gmail.com

Locations
Italy
Sant'Orsola Malpighi Hospital Recruiting
Bologna, Province, Italy, 40138
Contact: stefano nava    3333751828    stefanava@gmail.com   
San'Orsola Malpighi Hospital, Bologna ITALY Recruiting
Bologna, Italy, 40138
Contact: Stefano Nava, MD    051 6364017    stefano.nava@aosp.bo.it   
Principal Investigator: Stefano Nava, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Responsible Party: dr. Stefano Nava, Professor of Respiratory Medicine, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02929966     History of Changes
Other Study ID Numbers: 120/2016/O/Sper
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases