Early Palliative Care in Metastatic Lung Cancer in Northern France

Not Applicable

Terminated

• Conditions: Lung Cancer Metastatic
• Interventions: Other: multi disciplinary palliative care monthly consultations

• Registration Number: NCT02308865
• Lead Sponsor: University Hospital, Lille

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

Study Timeline

• Study Start: 2014-10-17
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Primary Completion: 2018-02-23
• Study Completion: 2018-02-23
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention arm	multi disciplinary palliative care monthly consultations	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.

Primary Outcome Measures

Name	Time	Method
quality of life	12 weeks	quality of life is measured at 12 weeks by the TOI score

Secondary Outcome Measures

Name	Time	Method
EVENTS	14 days before deaths	presence of any of the following: chemotherapy, use of resuscitation or no treatment limiting decision 14 days before deaths
QUALITY OF LIFE	12 and 21 weeks	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
SURVIVAL	from baseline

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France