Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer
18 Years
N/A
Both
Advanced Cancer
Trial Information
Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer
French clinical research in palliative care is confronted with a lack of tools allowing to
estimate in a standardized way a patient related outcome. Scales used today are not
specifically adapted to quality of life (QoL) at the end of life patient evaluation. So all
the relative dimensions to this disease stage are not estimated. What establishes a brake in
the improvement of a quality support.
The dimensions of pain, psychological distress, fatigue, decrease of the autonomy are
essential points estimated in "classic" questionnaires and frequently used at the palliative
disease stage. However the end of life also recovers the domains of the spirituality,
oneself's completion, relationship. These elements are essential to dread better QoL at end
of life, but are not or do not little approach on the French questionnaires.
The Missoula-Vitas Quality Of Life Index is a questionnaire developed by Byock, Merriman and
Kinzbrunner and specifically designed for palliative situations [I. Byock, 1998]. This QoL
tool provides an exhaustive assessment of important dimensions in this setting. The short
version is composed of 15 items and asks patients to evaluate 5 dimensions: symptoms,
function, interpersonal relationships, well-being and transcendence [I. Byock, 1998].
Another tool, the QUAL-E, is longer with 25 items concerning 5 domains: life completion,
relations with the health care system, preparation for end of life, symptom severity and
affective social support [KE. Steinhauser, 2002]. However, these QoL tools have not been
translated and adapted to French. Another concern is that the lack of specificity for cancer
patients.
The first step to improve evaluation of how French patients feel about this phase of their
disease is to translate these specific end of life QoL tools. Assessing QoL at the end of
life with dedicated tools could help to compare therapeutic strategies and could result in
improvements in palliative care.
Inclusion Criteria:
- Palliative advanced cancer patient (Palliative chemotherapy, analgesic radiotherapy,
surgery of comfort accepted).
- All cancer locations and cancer type
- Patient having the knowledge of their palliative disease stage.
- Patient follow-up at least once a month by a palliative caregiver.
- Age > or = 18 years.
- Dated and signed consent.
- PS > or = 2
- Life expectation > or = 1 month.
Exclusion Criteria:
- Psychiatric Disease or cognitive disorders disrupting the trial understanding and the
enlightened and voluntary consent character.
- Patient who can not submit itself to the formal follow-up for psychological, social,
family or geographical reasons
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI)
Outcome Description:
Both QUALE and MVQOLI have many questions, and each question is evaluated by a number of points. At the end of completion, a score is calculated thanks to number of points and is used to compare the different times completion : no change of score between the 2 first completion (reproductibility) change score with baseline correlation with QLQ-C15 PAL Score correlation with clinical measure (PS, PPS)
Outcome Time Frame:
Up to 3 years
Safety Issue:
No
Principal Investigator
Jean-Marie Commer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
ICO Paul Papin
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CPP-435
NCT ID:
NCT01545921
Start Date:
December 2010
Completion Date:
April 2014
Related Keywords:
- Advanced Cancer
- Quality Of Life
- Cancer
- End of life
- palliative setting
- Neoplasms
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