Early Palliative Care in Metastatic Lung Cancer in Northern France (IMPAQ)
Primary Purpose
Lung Cancer Metastatic
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
multi disciplinary palliative care monthly consultations
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer Metastatic focused on measuring Early palliative care, Lung cancer, Quality of life
Eligibility Criteria
Inclusion Criteria:
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
- PS ≤2
- Patient able to understand the nature, purpose and methodology of the study
- signed Informed consent
Exclusion Criteria:
- 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
Sites / Locations
- CHRU, Hôpital Claude Huriez
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control arm
intervention arm
Arm Description
Patient supported by the onco respiratory service for the treatment of their disease by chemotherapy and for the treatment of complications.
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.
Outcomes
Primary Outcome Measures
quality of life
quality of life is measured at 12 weeks by the TOI score
Secondary Outcome Measures
SURVIVAL
EVENTS
presence of any of the following: chemotherapy, use of resuscitation or no treatment limiting decision 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
Full Information
NCT ID
NCT02308865
First Posted
December 2, 2014
Last Updated
July 9, 2019
Sponsor
University Hospital, Lille
Collaborators
Santelys Association, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT02308865
Brief Title
Early Palliative Care in Metastatic Lung Cancer in Northern France
Acronym
IMPAQ
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
sponsor decision
Study Start Date
October 17, 2014 (Actual)
Primary Completion Date
February 23, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Santelys Association, Novartis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Metastatic
Keywords
Early palliative care, Lung cancer, Quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patient supported by the onco respiratory service for the treatment of their disease by chemotherapy and for the treatment of complications.
Arm Title
intervention arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
multi disciplinary palliative care monthly consultations
Intervention Description
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
Primary Outcome Measure Information:
Title
quality of life
Description
quality of life is measured at 12 weeks by the TOI score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
SURVIVAL
Time Frame
from baseline
Title
EVENTS
Description
presence of any of the following: chemotherapy, use of resuscitation or no treatment limiting decision 14 days before deaths
Time Frame
14 days before deaths
Title
QUALITY OF LIFE
Description
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
Time Frame
12 and 21 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
PS ≤2
Patient able to understand the nature, purpose and methodology of the study
signed Informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Licia Touzet, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20818875
Citation
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.
Results Reference
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Early Palliative Care in Metastatic Lung Cancer in Northern France
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