Palliative Care in Pulmonary Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Palliative Care in Patients With End Stage Pulmonary Fibrosis: a Randomized Control Pilot Study

Conditions
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Idiophatic Pulmonary Fibrosis

Intervention / Treatment
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* Other: palliative care program
* Other: standard respiratory care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: standard respiratory care<br>The patients will receive the usual respiratory care that included both the classical treatments with antifibrotic drugs and oxygen therapy | Other: standard respiratory care<br>* the usual standard pharmacological care plus oxygen therapy<br>|
| Experimental: standard respiratory care PLUS a palliative care program<br>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<br>* The program includes psychological support, spiritual care and respiratory therapist support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical status and quality of life | Maugeri Respiratory Questionnaire reduced form | 12 months | 
| depression | Center for Epidemiologic Studies Depression score (C-ESDs) | 12 months | 
| dyspnea score | Borg scale | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 12 months |