Palliative Care in Pulmonary Fibrosis

Not Applicable

Completed

• Conditions: Idiophatic Pulmonary Fibrosis
• Interventions: Other: palliative care program; Other: standard respiratory care

• Registration Number: NCT02929966
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-08
• Study First Posted: 2016-10-11
• Primary Completion: 2018-12
• Study Completion: 2019-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard respiratory care PLUS a palliative care program	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
standard respiratory care	standard respiratory care	The patients will receive the usual respiratory care that included both the "classical" treatments with antifibrotic drugs and oxygen therapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
survival	12 months

Trial Locations

Locations (2)

Sant'Orsola Malpighi Hospital; 🇮🇹 Bologna, Province, Italy

San'Orsola Malpighi Hospital, Bologna ITALY; 🇮🇹 Bologna, Italy