NCT02899585

Brief Summary

The aim of the research is to detect prematurely vulnerable patients needing a global coverage in integrated care with a created and metrological validated score.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

4.2 years

First QC Date

September 9, 2016

Last Update Submit

May 15, 2019

Conditions

Incurable Disease

Keywords

Palliative care

Outcome Measures

Primary Outcomes (1)

  • Capacity of the score to be discriminated (area under the curve) to find the patients who need or not a palliative approach

    15 days

Study Arms (2)

Group A

EXPERIMENTAL

Elaboration of the questionnaires

Other: Questionnaires

Group B

EXPERIMENTAL

Patients taken care for more less than 6 days by the health care team palliatives EIVA and they eventual family caregiver. Score

Other: QuestionnairesOther: Score

Interventions

QuestionnairesOTHER
Group AGroup B
ScoreOTHER
Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients hospitalized with:
  • an evolutionary incurable disease;
  • Taken care for more than a month by the health care team palliatives EIVA (except for the last 200 patients, for whom the deadline extension of palliative care is lower that 6 days);
  • Benefiting of asocial scheme or claimant
  • Having signed the informed consent as well as his(her) family caregiver, if this one participates in the research.

You may not qualify if:

  • Patient:
  • Having difficulty of understanding of the French language
  • Having a life expectancy estimated unless one month
  • un controlled physical or psychic distress (anxiety and/or depression)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (8)

  • Arraras JI, Greimel E, Sezer O, Chie WC, Bergenmar M, Costantini A, Young T, Vlasic KK, Velikova G. An international validation study of the EORTC QLQ-INFO25 questionnaire: an instrument to assess the information given to cancer patients. Eur J Cancer. 2010 Oct;46(15):2726-38. doi: 10.1016/j.ejca.2010.06.118. Epub 2010 Jul 30.

    PMID: 20674333BACKGROUND

  • Ferrand E, Robert R, Ingrand P, Lemaire F; French LATAREA Group. Withholding and withdrawal of life support in intensive-care units in France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan 6;357(9249):9-14. doi: 10.1016/s0140-6736(00)03564-9.

    PMID: 11197395RESULT

  • Ferrand E, Jabre P, Vincent-Genod C, Aubry R, Badet M, Badia P, Cariou A, Ellien F, Gounant V, Gil R, Jaber S, Jay S, Paillaud E, Poulain P, Regnier B, Reignier J, Socie G, Tardy B, Lemaire F, Brun-Buisson C, Marty J; French Mort-a-l'Hopital Group. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hopital survey. Arch Intern Med. 2008 Apr 28;168(8):867-75. doi: 10.1001/archinte.168.8.867.

    PMID: 18443263RESULT

  • 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: 20818875RESULT

  • Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.

    PMID: 22203758RESULT

  • Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.

    PMID: 23358690RESULT

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PMID: 6880820RESULT

  • Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.

    PMID: 15029085RESULT

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Edouard Ferrand, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 14, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

May 17, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

Locations

FR(1)