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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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