Clinical trial NCT02899585: Expression of a Need of Implication for the Vulnerable Patient and His Adaptation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incurable Disease
Keywords: Palliative care
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Capacity of the score to be discriminated (area under the curve) to find the patients who need or not a palliative approach
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Edouard Ferrand, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.