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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02308865
Date of registration: 02/12/2014
Prospective Registration: No
Primary sponsor: University Hospital, Lille
Public title: Early Palliative Care in Metastatic Lung Cancer in Northern France IMPAQ
Scientific title: Impact of Early Palliative Care on Quality of Life and Survival of Patients With Non-small-cell Metastatic Lung Cancer in Northern France
Date of first enrolment: October 17, 2014
Target sample size: 71
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02308865
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Licia Touzet, MD
Address: 
Telephone:
Email:
Affiliation:  University Hospital, Lille
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Lung Cancer Metastatic
Intervention(s)
Other: multi disciplinary palliative care monthly consultations
Primary Outcome(s)
quality of life [Time Frame: 12 weeks]
Secondary Outcome(s)
QUALITY OF LIFE [Time Frame: 12 and 21 weeks]
EVENTS [Time Frame: 14 days before deaths]
SURVIVAL [Time Frame: from baseline]
Secondary ID(s)
2013_70
2014-A00514-43
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Santélys
Novartis
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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