IMPAQ: Early Palliative Care in Metastatic Lung Cancer in Northern France

Sponsor

University Hospital, Lille (Other)

Overall Status

Terminated

CT.gov ID

NCT02308865

Collaborator

Santelys Association (Other), Novartis (Industry)

Enrollment

Location

Arms

40.2

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Metastatic	Other: multi disciplinary palliative care monthly consultations	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Oct 17, 2014

Actual Primary Completion Date :

Feb 23, 2018

Actual Study Completion Date :

Feb 23, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

quality of life [12 weeks]
quality of life is measured at 12 weeks by the TOI score

Secondary Outcome Measures

SURVIVAL [from baseline]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU, Hôpital Claude Huriez	Lille		France	59000

Sponsors and Collaborators

University Hospital, Lille
Santelys Association
Novartis

Investigators

Principal Investigator: Licia Touzet, MD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT02308865

Other Study ID Numbers:

2013_70
2014-A00514-43

First Posted:

Dec 4, 2014

Last Update Posted:

Jul 11, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

Early palliative care

Lung cancer

Quality of life

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Jul 11, 2019