Lung Cancer MetastaticIMPAQNCT02308865
Early Palliative Care in Metastatic Lung Cancer in Northern France
A study testing multi disciplinary palliative care monthly consultations in people with Lung Cancer Metastatic, run by University Hospital, Lille at 1 site in France.
Trial summary
Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing early Palliative care versus Standard care in patients with non-small-cell metastatic lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Metastatic
- What is being tested?
- multi disciplinary palliative care monthly consultations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2014to 23 Feb 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with non-small cell lung cancer
- Proven histologically
- Metastatic proven imaging (MRI, CT Scanner, PET scan)
- Stage IV (any T, any N, M1)
- prior to secondary chemotherapy treatment.
- Age> 18 years
Show all 9Show fewer
- PS ≤2
- Patient able to understand the nature, purpose and methodology of the study
- signed Informed consent
Who cannot join
- Age <18 years
- Patient already supported by palliative care
- Patient with an activating EGFR mutation or EML4-ALK rearrangement or ROS1 gene translocation
- Patient under trusteeship / guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Early Palliative Care on Quality of Life and Survival of Patients With Non-small-cell Metastatic Lung Cancer in Northern France
Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing early Palliative care versus Standard care in patients with non-small-cell metastatic lung cancer
Read the detailed description
144 patients will be included; 72 per arm.
- "Standard" Control arm: patient supported by the onco-respiratory service.
- Intervention arm: patients benefit from early palliative care in addition to standard onco-pneumologic care.
The main criterion of judgment is the TOI score measured at 12 weeks.
FACTL questionnaires, HADS and PHQ-9 will be filled out before randomization , at 12 weeks and 21 weeks
- Conditions
- Lung Cancer Metastatic
- Being tested
- multi disciplinary palliative care monthly consultations
- Keywords
- Early palliative care, Lung cancer, Quality of life
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi disciplinary palliative care monthly consultationsOther
multi disciplinary palliative care consultations with a doctor, a nurse, a psychologist and posibility of a physical therapist and a worship person.The primary consultation within 3 weeks inclusion and then every month at the same time that consultations onco-respiratory
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Patient supported by the onco respiratory service for the treatment of their disease by chemotherapy and for the treatment of complications. |
| intervention arm | Experimental | Multi disciplinary palliative care monthly consultations with a doctor, a nurse, a psychologist and posibility of a physical therapist and a chaplain in addition to standard onco-pneumologic care. Receives: Other: multi disciplinary palliative care monthly consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
quality of life is measured at 12 weeks by the TOI score
Measured: 12 weeks
Secondary outcomes (3)
SURVIVAL
Measured: from baseline
EVENTS
presence of any of the following: chemotherapy, use of resuscitation or no treatment limiting decision 14 days before deaths
Measured: 14 days before deaths
QUALITY OF LIFE
quality of life is measured by the score TOI at 12 weeks and by the Echelle SCNS - SF34 scale, FACTL, PHQ-9 and HADS questionnaires at 12 and 21 weeks
Measured: 12 and 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study start17 Oct 2014
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Why it stopped: sponsor decision
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 Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Santelys Association, Novartis
- Responsible party
- Sponsor
- Investigators
- Licia Touzet, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308865
- Sponsor's protocol ID
- 2013_70
- Other IDs
- 2014-A00514-43
- Acronym
- IMPAQ
- Status last verified
- Jul 2019
- First submitted
- 2 Dec 2014
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Temel 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 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Palliative Care on Quality of Life and Survival of Patients With Non-small-cell Metastatic Lung Cancer in Northern France
- ClinicalTrials.gov ID
- NCT02308865
- Acronym / sponsor ID
- IMPAQ / 2013_70
- Conditions
- Lung Cancer Metastatic
- Keywords
- Early palliative care, Lung cancer, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Santelys Association, Novartis
- Study start
- 17 Oct 2014 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 4 Dec 2014 (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.
Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing early Palliative care versus Standard care in patients with non-small-cell metastatic lung cancer
Detailed description
144 patients will be included; 72 per arm.
- "Standard" Control arm: patient supported by the onco-respiratory service.
- Intervention arm: patients benefit from early palliative care in addition to standard onco-pneumologic care.
The main criterion of judgment is the TOI score measured at 12 weeks.
FACTL questionnaires, HADS and PHQ-9 will be filled out before randomization , at 12 weeks and 21 weeks
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Patient supported by the onco respiratory service for the treatment of their disease by chemotherapy and for the treatment of complications. |
| intervention arm | Experimental | Other: multi disciplinary palliative care monthly consultationsMulti disciplinary palliative care monthly consultations with a doctor, a nurse, a psychologist and posibility of a physical therapist and a chaplain in addition to standard onco-pneumologic care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being diagnosed with non-small cell lung cancer
- prior to secondary chemotherapy treatment.
- Age> 18 years
- PS ≤2
- Patient able to understand the nature, purpose and methodology of the study
Key exclusion criteria (4 listed)
- Age <18 years
- Patient already supported by palliative care
- Patient with an activating EGFR mutation or EML4-ALK rearrangement or ROS1 gene translocation
- Patient under trusteeship / guardianship
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 |
|---|---|---|
| multi disciplinary palliative care monthly consultationsmulti disciplinary palliative care consultations with a doctor, a nurse, a psychologist and posibility of a physical therapist and a worship person.The primary consultation within 3 weeks inclusion and then every month at the same time that consultations onco-respiratory | Other | intervention arm |
Primary outcome
quality of life
Time frame: 12 weeks
quality of life is measured at 12 weeks by the TOI score
3 secondary outcomes
SURVIVAL
Time frame: from baseline
EVENTS
Time frame: 14 days before deaths
QUALITY OF LIFE
Time frame: 12 and 21 weeks
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- 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.
Licia Touzet, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi disciplinary palliative care monthly consultations in people with Lung Cancer Metastatic, run by University Hospital, Lille at 1 site 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 9 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
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?
quality of life (time frame: 12 weeks). 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 NCT02308865, 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 11 Jul 2019.