Early Palliative Care in Metastatic Lung Cancer in Northern France (IMPAQ)

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

Study Overview

• Status: Terminated
• Conditions: Lung Cancer Metastatic
• Intervention / Treatment: Other: multi disciplinary palliative care monthly consultations

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • CHRU, Hôpital Claude Huriez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Patient supported by the onco respiratory service for the treatment of their disease by chemotherapy and for the treatment of complications.
Experimental: intervention arm; 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.	Other: multi disciplinary palliative care monthly consultations; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	quality of life is measured at 12 weeks by the TOI score	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SURVIVAL		from baseline
EVENTS	presence of any of the following: chemotherapy, use of resuscitation or no treatment limiting decision 14 days before deaths	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	12 and 21 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Novartis; Santelys Association
• Investigators: Principal Investigator: Licia Touzet, MD, University Hospital, Lille

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2014
• Primary Completion (Actual): February 23, 2018
• Study Completion (Actual): February 23, 2018

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Quality of life; Lung cancer; Early palliative care
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2013_70; 2014-A00514-43 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No