Palliative Care in Pulmonary Fibrosis

Idiophatic Pulmonary Fibrosis Clinical Trial

— PULFIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929966
• Other study ID #: 120/2016/O/Sper
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: March 2019

Study information

• Verified date: October 2020
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiophatic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• palliative care program
The program includes psychological support, spiritual care and respiratory therapist support
• standard respiratory care
the usual standard pharmacological care plus oxygen therapy

Locations

Country	Name	City	State
Italy	San'Orsola Malpighi Hospital, Bologna ITALY	Bologna
Italy	Sant'Orsola Malpighi Hospital	Bologna	Province

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical status and quality of life	Maugeri Respiratory Questionnaire reduced form	12 months
Primary	depression	Center for Epidemiologic Studies Depression score (C-ESDs)	12 months
Primary	dyspnea score	Borg scale	12 months
Secondary	survival		12 months