Early Palliative Care in Metastatic Lung Cancer in Northern France

NCT02308865 | Terminated DMC

• 2 other identifiers: 2013_702014-A00514-43
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer Metastatic

Keywords

Early palliative care; Lung cancer; Quality of life

Outcome Measures

Primary Outcomes (1)

• quality of life

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

  12 weeks

Secondary Outcomes (3)

• SURVIVAL

  from baseline

• EVENTS

  14 days before deaths

• QUALITY OF LIFE

  12 and 21 weeks

Study Arms (2)

Control arm

NO INTERVENTION

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

intervention arm

EXPERIMENTAL

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

Interventions

multi disciplinary palliative care monthly consultations 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

intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Santelys Association: collaborator
• Novartis: collaborator

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, 59000, France

Location

Related 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.

  PMID: 20818875 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Licia Touzet, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: October 17, 2014
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)