Idiophatic Pulmonary FibrosisPULFIPNCT02929966
Palliative Care in Pulmonary Fibrosis
A study testing palliative care program and standard respiratory care in people with Idiophatic Pulmonary Fibrosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Idiophatic Pulmonary Fibrosis
- What is being tested?
- palliative care program and standard respiratory care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- active treatment with antifibrotic drug
- concomitant cancer
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Sant'Orsola Malpighi Hospital
Bologna, Province, 40138
San'Orsola Malpighi Hospital, Bologna ITALY
Bologna, 40138
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiophatic Pulmonary Fibrosis
- Being tested
- palliative care program, standard respiratory care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palliative care programOther
The program includes psychological support, spiritual care and respiratory therapist support
standard respiratory careOther
the usual standard pharmacological care plus oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| standard respiratory care | Placebo comparator | The patients will receive the usual respiratory care that included both the "classical" treatments with antifibrotic drugs and oxygen therapy Receives: Other: standard respiratory care |
| standard respiratory care PLUS a palliative care program | Experimental | 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 Receives: Other: palliative care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical status and quality of life
Maugeri Respiratory Questionnaire reduced form
Measured: 12 months
depression
Center for Epidemiologic Studies Depression score (C-ESDs)
Measured: 12 months
dyspnea score
Borg scale
Measured: 12 months
Secondary outcomes (1)
survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiophatic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929966
- Sponsor's protocol ID
- 120/2016/O/Sper
- Acronym
- PULFIP
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2016
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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. 2023 Dec;29 Suppl 4:S54-S62. doi: 10.1016/j.pulmoe.2021.11.004. Epub 2021 Dec 28.
PubMed 34969647
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Palliative Care in Patients With End Stage Pulmonary Fibrosis: a Randomized Control Pilot Study
- ClinicalTrials.gov ID
- NCT02929966
- Acronym / sponsor ID
- PULFIP / 120/2016/O/Sper
- Conditions
- Idiophatic Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard respiratory care | Placebo comparator | Other: standard respiratory careThe patients will receive the usual respiratory care that included both the "classical" treatments with antifibrotic drugs and oxygen therapy |
| standard respiratory care PLUS a palliative care program | Experimental | Other: palliative care programThe 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- active treatment with antifibrotic drug
- concomitant cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palliative care programThe program includes psychological support, spiritual care and respiratory therapist support | Other | standard respiratory care PLUS a palliative care program |
| standard respiratory carethe usual standard pharmacological care plus oxygen therapy | Other | standard respiratory care |
Primary outcome
clinical status and quality of life
Time frame: 12 months
Maugeri Respiratory Questionnaire reduced form
depression
Time frame: 12 months
Center for Epidemiologic Studies Depression score (C-ESDs)
dyspnea score
Time frame: 12 months
Borg scale
1 secondary outcome
survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Derived from this study: PubMed 34969647Bassi 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. 2023 Dec;29 Suppl 4:S54-S62. doi: 10.1016/j.pulmoe.2021.11.004. Epub 2021 Dec 28.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palliative care program and standard respiratory care in people with Idiophatic Pulmonary Fibrosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical status and quality of life (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.