Early Palliative Care in Metastatic Lung Cancer in Northern France

Lung Cancer Metastatic Clinical Trial

— IMPAQ  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02308865
• Other study ID #: 2013_70
• Secondary ID: 2014-A00514-43
• Status: Terminated
• Phase: N/A
• Start date: October 17, 2014
• Est. completion date: February 23, 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer Metastatic
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Novartis, Santélys

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life	quality of life is measured at 12 weeks by the TOI score	12 weeks
Secondary	SURVIVAL		from baseline
Secondary	EVENTS	presence of any of the following: chemotherapy, use of resuscitation or no treatment limiting decision 14 days before deaths	14 days before deaths
Secondary	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