Incurable Disease Clinical Trial
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.
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
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