Idiopathic Pulmonary FibrosisPALIFNCT03229343
Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis.
A study testing Supportive care in people with Idiopathic Pulmonary Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
Trial summary
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life. In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 11 sitesFrance
- Study dates
- 4 Dec 2017to Feb 2021
- 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 40 years
- Patient with confirmed diagnosis of IPF according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT) criteria. The patient may be included regardless of the date of diagnosis.
- Advanced IPF with Forced Vital Capacity (FVC) <50%" of predicted value and / or Diffusing capacity for carbon monoxide ((DLCO) <30% of predicted value or inability to achieve the Functional Respiratory Investigations (EFR) due to respiratory severity. EFR dated less than 3 months.
- Absence of argument for acute or subacute exacerbation in the last 6 months.
- Patient who can be followed in ambulatory consultation/ outpatient consultation.
- Informed consent signed (signed by the patient or in the presence of a third party for patients who are poorly fluent in French).
- Affiliation to the social security system.
Who cannot join
- Patient unable to respond to quality of life questionnaires.
- Inability (physical or mental) to give a written informed consent.
- Acute exacerbation of fibrosis in the previous 6 months.
- Patient eligible for a pulmonary transplant.
- Participation in other therapeutic trial
- Patient cannot be followed in ambulatory consultation.
- Patient under trustee
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
Centre Hospitalier Robert Ballanger
Aulnay-sous-Bois, 93602
Jérome VIRALLY, Pr
- Recruiting
Hôpital Avicenne
Bobigny, 93000
Boris DUCHEMANN, PI
- Not yet recruiting
Centre Hospitalier de Versailles Andre Mignot
Le Chesnay, 78150
Nathalie MICHENOT, Dr
- Recruiting
Hôpital LOUIS PRADEL
Lyon, 69677
Vicent COTTIN, Pr
- Not yet recruiting
Hôpital NORD
Marseille, 13015
Martine REYNAUD GAUBERT, Pr
- Recruiting
Hôpital MARC JACQUET
Melun
Djamel BENNEGADI, Dr
- Not yet recruiting
Hôpital GEORGES POMPIDOU (HEGP)
Paris, 75015
Dominique ISRAEL-BIET, Pr
- Not yet recruiting
Hôpital Tenon
Paris, 75020
Jean Marc NACCACHE, Pr
- Recruiting
Hôpital Pontchaillou
Rennes, 35033
Stéphane JOUNEAU, Pr
- Not yet recruiting
Hôpital DELAFONTAINE
Saint-Denis, 93200
Isabelle LERAT, Dr
- Not yet recruiting
Hôpital LARREY
Toulouse, 31059
Grégoire PREVOT, Dr
About this study
Official title: Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis (IPF). A Randomized Multi-center Trial.
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life.
In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients.
Read more
In the princeps study published in 2010, the early intervention of a dedicated palliative care team was compared to standard care in a randomized trial of 150 patients and shows a significant improvement : (i) of quality of life (main objective), (ii) of depression scores and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted hospitalization in end of life (in emergency or not).
Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory symptom, psychological burden), it seemed reasonable to assume that the joint systematic intervention of chest physician and palliative care team may provide a significant benefit in terms of quality of life for patients with severe IPF.
Read the detailed description
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life. This alteration results from different consequences of the IPF: progressive shortness of breath, irritative cough refractory to treatments, exhaustion, limitation of activity, social isolation, and psychic consequences such as fear, anxiety and depression.
The only current curative treatment of the disease is pulmonary transplantation, but it's only feasible for a minority of patients. Anti-fibrotic drugs, such as pirfenidone and nintedanib, are likely to slow the progression of IPF but have no impact on patients' quality of life.
The symptomatic treatment aimed at relieving respiratory discomfort and the patient's quality of life is therefore fundamental, and the IPF meets in many ways the challenges of lung cancer.
In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients.
In the princeps study published in 2010, the early intervention of a dedicated palliative care team was compared to standard care in a randomized trial of 150 patients and shows a significant improvement : (i) of quality of life (main objective), (ii) of depression scores and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted hospitalization in end of life (in emergency or not).
Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory symptom, psychological burden), it seemed reasonable to assume that the joint systematic intervention of chest physician and palliative care team may provide a significant benefit in terms of quality of life for patients with severe IPF.
Objective:
To investigate the benefit on quality of life, evaluated after 6 months, of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team compared to standard care for patients with severe IPF.
Secondary endpoints
- To evaluate the benefit of the systematic, formalized and joint intervention of a palliative care team and a chest physician team on:
- Mood and depression
- Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives regarding end-of-life
- Respiratory symptoms (cough and dyspnea)
- The course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations).
- Overall survival and place of death.
- Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Supportive care
- Keywords
- idiopathic pulmonary fibrosis, palliative care
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive careOther
supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6. Receives: Other: Supportive care |
| standard | No intervention | pneumological consultation performed at M0, M3 and M6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The benefit of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team on quality of life, evaluated after 6 months by the Short Form (36) Health Survey.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The Short Form (36) Health Survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. This score has already been used for IPF
Measured: at 6 months after inclusion
Secondary outcomes (6)
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Mood and depression
evaluated by the Hospital Anxiety and Depression questionnaire.
- Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives
- Respiratory symptoms (dyspnea)
- The course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations).
- Overall survival and place of death.
Measured: at 3 and 6 months after inclusion
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives.
the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives will be evaluated by the illness understanding questionnaire.
Measured: at 3 and 6 months after inclusion
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea)
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea) will be evaluated by St George's respiratory questionnaire (SGRQ) and Transition Dyspnea Index (TDI)
Measured: at 3 and 6 months after inclusion
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care.
the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations)
Measured: at 3 and 6 months after inclusion
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival.
the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival measured between inclusion and date of death or last news.
Measured: between inclusion and date of death or last news. (survival follow-up visit at month 12)
Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion)
This outcome is evaluated by the medico-economic questionnaire : EuroQol five dimensions questionnaire (EQ-5D)
Measured: at 3 and 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start4 Dec 2017
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Model description
- Experimental arm : supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6. Non interventionnel arm: only pneumological consultation performed at M0, M3 and M6.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Duchemann, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229343
- Sponsor's protocol ID
- P150965
- Acronym
- PALIF
- Status last verified
- Jul 2017
- First submitted
- 4 Jul 2017
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swigris JJ, Brown KK, Behr J, du Bois RM, King TE, Raghu G, Wamboldt FS. The SF-36 and SGRQ: validity and first look at minimum important differences in IPF. Respir Med. 2010 Feb;104(2):296-304. doi: 10.1016/j.rmed.2009.09.006. Epub 2009 Oct 7.
PubMed 19815403Swigris JJ, Kuschner WG, Jacobs SS, Wilson SR, Gould MK. Health-related quality of life in patients with idiopathic pulmonary fibrosis: a systematic review. Thorax. 2005 Jul;60(7):588-94. doi: 10.1136/thx.2004.035220.
PubMed 15994268Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
PubMed 20818875
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis (IPF). A Randomized Multi-center Trial.
- ClinicalTrials.gov ID
- NCT03229343
- Acronym / sponsor ID
- PALIF / P150965
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- idiopathic pulmonary fibrosis, palliative care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 25 Jul 2017 (actual)
- 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.
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life.
In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients.
In the princeps study published in 2010, the early intervention of a dedicated palliative care team was compared to standard care in a randomized trial of 150 patients and shows a significant improvement : (i) of quality of life (main objective), (ii) of depression scores and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted hospitalization in end of life (in emergency or not).
Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory symptom, psychological burden), it seemed reasonable to assume that the joint systematic intervention of chest physician and palliative care team may provide a significant benefit in terms of quality of life for patients with severe IPF.
Detailed description
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life. This alteration results from different consequences of the IPF: progressive shortness of breath, irritative cough refractory to treatments, exhaustion, limitation of activity, social isolation, and psychic consequences such as fear, anxiety and depression.
The only current curative treatment of the disease is pulmonary transplantation, but it's only feasible for a minority of patients. Anti-fibrotic drugs, such as pirfenidone and nintedanib, are likely to slow the progression of IPF but have no impact on patients' quality of life.
The symptomatic treatment aimed at relieving respiratory discomfort and the patient's quality of life is therefore fundamental, and the IPF meets in many ways the challenges of lung cancer.
In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients.
In the princeps study published in 2010, the early intervention of a dedicated palliative care team was compared to standard care in a randomized trial of 150 patients and shows a significant improvement : (i) of quality of life (main objective), (ii) of depression scores and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted hospitalization in end of life (in emergency or not).
Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory symptom, psychological burden), it seemed reasonable to assume that the joint systematic intervention of chest physician and palliative care team may provide a significant benefit in terms of quality of life for patients with severe IPF.
Objective:
To investigate the benefit on quality of life, evaluated after 6 months, of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team compared to standard care for patients with severe IPF.
Secondary endpoints
- To evaluate the benefit of the systematic, formalized and joint intervention of a palliative care team and a chest physician team on:
- Mood and depression
- Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives regarding end-of-life
- Respiratory symptoms (cough and dyspnea)
- The course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations).
- Overall survival and place of death.
- Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental arm : supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6. Non interventionnel arm: only pneumological consultation performed at M0, M3 and M6.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Supportive careSupportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6. |
| standard | No intervention | –pneumological consultation performed at M0, M3 and M6 |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age> 40 years
- Patient with confirmed diagnosis of IPF according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT) criteria. The patient may be included regardless of the date of diagnosis.
- Advanced IPF with Forced Vital Capacity (FVC) <50%" of predicted value and / or Diffusing capacity for carbon monoxide ((DLCO) <30% of predicted value or inability to achieve the Functional Respiratory Investigations (EFR) due to respiratory severity. EFR dated less than 3 months.
- Absence of argument for acute or subacute exacerbation in the last 6 months.
- Patient who can be followed in ambulatory consultation/ outpatient consultation.
Key exclusion criteria (7 listed)
- Patient unable to respond to quality of life questionnaires.
- Inability (physical or mental) to give a written informed consent.
- Acute exacerbation of fibrosis in the previous 6 months.
- Patient eligible for a pulmonary transplant.
- Participation in other therapeutic trial
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 |
|---|---|---|
| Supportive caresupportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6. | Other | Experimental |
Primary outcome
The benefit of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team on quality of life, evaluated after 6 months by the Short Form (36) Health Survey.
Time frame: at 6 months after inclusion
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The Short Form (36) Health Survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. This score has already been used for IPF
6 secondary outcomes
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Mood and depression
Time frame: at 3 and 6 months after inclusion
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives.
Time frame: at 3 and 6 months after inclusion
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea)
Time frame: at 3 and 6 months after inclusion
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care.
Time frame: at 3 and 6 months after inclusion
The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival.
Time frame: between inclusion and date of death or last news. (survival follow-up visit at month 12)
Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion)
Time frame: at 3 and 6 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 19815403Swigris JJ, Brown KK, Behr J, du Bois RM, King TE, Raghu G, Wamboldt FS. The SF-36 and SGRQ: validity and first look at minimum important differences in IPF. Respir Med. 2010 Feb;104(2):296-304. doi: 10.1016/j.rmed.2009.09.006. Epub 2009 Oct 7.
- Background: PubMed 15994268Swigris JJ, Kuschner WG, Jacobs SS, Wilson SR, Gould MK. Health-related quality of life in patients with idiopathic pulmonary fibrosis: a systematic review. Thorax. 2005 Jul;60(7):588-94. doi: 10.1136/thx.2004.035220.
- Background: PubMed 20818875Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
- Individual participant dataSharing planned: No
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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.
Boris Duchemann principal investigator
Assistance Publique - Hôpitaux de Paris
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care in people with Idiopathic Pulmonary Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Duchemann, Dr (01 48 95 50 32, boris.duchemann@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The benefit of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team on quality of life, evaluated after 6 months by the Short Form (36) Health Survey. (time frame: at 6 months after inclusion). 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 NCT03229343, which also lists 3 linked publications.
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 26 Jan 2018.