Palliative Care in Pulmonary Fibrosis (PULFIP)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Idiophatic Pulmonary Fibrosis

Treatments: Other: standard respiratory care; Other: palliative care program

Study type: Interventional

Funder types: Other

Identifiers

NCT02929966

120/2016/O/Sper

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

standard respiratory care

Placebo Comparator group

Description:

The patients will receive the usual respiratory care that included both the "classical" treatments with antifibrotic drugs and oxygen therapy

Treatment:

Other: standard respiratory care

standard respiratory care PLUS a palliative care program

Experimental group

Description:

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

Treatment:

Other: palliative care program