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

University Hospital, Lille

Status: Terminated

Conditions: Lung Cancer Metastatic

Treatments: Other: multi disciplinary palliative care monthly consultations

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02308865

2013_70

2014-A00514-43 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Control arm

No Intervention group

Description:

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

intervention arm

Experimental group

Description:

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.

Treatment:

Other: multi disciplinary palliative care monthly consultations