Expression of a Need of Implication for the Vulnerable Patient and His Adaptation

Incurable Disease Clinical Trial

— EIVA  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02899585
• Other study ID #: 2014/27
• Secondary ID: 2014-A01386-41
• Status: Terminated
• Phase: N/A
• Start date: January 2015
• Est. completion date: March 2019

Study information

• Verified date: May 2019
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The respect for the rights of the patients in palliative phase - having an evolutionary or terminal grave pathology - is a legal requirement since 1999, strengthened by the laws of April 4th, 2002 and April 22nd, 2005. Nevertheless, a lack of palliative approach persists, that is premature awareness of the necessity of a global approach, not exclusively centred on the specific therapeutics. The palliative approach remains rare and especially most of the time reduced in the last days of the life. The lack of distribution of the legal texts and insufficient training are among the main reasons. The lack of educational tools is probably also a major brake in a premature reflection.

Primary objective : to detect prematurely vulnerable patients needing a global coverage in integrated care with a created and metrological validated score.

Primary endpoint: capacity of the score to be discriminated (area under the curve) to find the patients who need or not a palliative approach

Secondary objectives:

• The measure of the relevance of the tests of quality of life, personality traits, level of information and anxiety depression to detect prematurely the vulnerable patients and/or their family caregivers who need an approach of palliative care in integrated care;

• The detail (date, nature of the event) of the various stages of their life course, during which the vulnerable patients needing a premature global care were taken care within the framework of such an approach, compared with their theoretical detection by the score of premature detection scale;

• The evaluation of the concordance between the patient score and the family caregiver score, if he participates in the research.

Secondary endpoints:

• The tests estimating the anxiety and the depression ( HAD (Hospital Anxiety and Depression) score), the personality and adaptation traits, Brief Cope;

• The quality of life tests EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) and level of information EORTC INF-30 (Information-30) for the cancer patients;

• The deadline between detection by the score and effective global care

• The deadline between detection by the score and the cessation of the specific treatments

• The deadline between detection by the score and the death

• The patient and close scores obtained in the validation phase.

Methods: Prospective, controlled, nonrandomized study

Number of patients to include: 610 (maximum)

Duration: 36 months (32 inclusion months).

Number of participating centers: 1 center

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

The absence of family caregiver is not an exclusion criterion.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Incurable Disease

Intervention

Other:
• Questionnaires

• Score

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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'Hôpital Group. Circum — View Citation

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. — View Citation

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):394-4 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capacity of the score to be discriminated (area under the curve) to find the patients who need or not a palliative approach		15 days