Impact of Early Palliative Care on Quality of Life and Survival of Patients With Non-small-cell Metastatic Lung Cancer in Northern France

University Hospital, Lille1 site in 1 country71 target enrollmentOctober 17, 2014

ConditionsLung Cancer Metastatic

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lung Cancer Metastatic
Sponsor: University Hospital, Lille
Enrollment: 71
Locations: 1
Primary Endpoint: quality of life
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 17, 2014

End Date

February 23, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

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
•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