Early Palliative Care in Metastatic Lung Cancer in Northern France

NCT ID: NCT02308865

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-17
• Study Completion Date: 2018-02-23

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

Conditions

Lung Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control arm

Patient supported by the onco respiratory service for the treatment of their disease by chemotherapy and for the treatment of complications.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

multi disciplinary palliative care monthly consultations

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santelys Association

OTHER

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Licia Touzet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CHRU, Hôpital Claude Huriez

Lille, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 20818875 (View on PubMed)

Other Identifiers

2014-A00514-43

Identifier Type: OTHER

Identifier Source: secondary_id

2013_70

Identifier Type: -

Identifier Source: org_study_id