Palliative Care in Pulmonary Fibrosis (PULFIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Idiophatic Pulmonary Fibrosis
• Intervention / Treatment: Other: standard respiratory care; Other: palliative care program

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • san'Orsola Malpighi Hospital, Bologna ITALY
  • Province
    • Bologna, Province, Italy, 40138
      • sant'orsola malpighi hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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	Time Frame
survival	12 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

General Publications

• Bassi I, Guerrieri A, Carpano M, Gardini A, Prediletto I, Polastri M, Curtis JR, Nava S. Feasibility and efficacy of a multidisciplinary palliative approach in patients with advanced interstitial lung disease. A pilot randomised controlled trial. Pulmonology. 2021 Dec 27:S2531-0437(21)00223-3. doi: 10.1016/j.pulmoe.2021.11.004. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: October 8, 2016
• First Submitted That Met QC Criteria: October 8, 2016
• First Posted (ESTIMATE): October 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis
• Other Study ID Numbers: 120/2016/O/Sper

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO