Clinical trial NCT01545921: Cancer End Of Life Evaluation
Official title: Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Advanced Cancer
Keywords: Quality Of Life
Cancer
End of life
palliative setting
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated to the end of life for French cancer patients.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Change in Quality of Life at different times
timeFrame: Up to 3 years
measure: Number of spontaneous questionnaire completions
timeFrame: Up to 3 years
measure: Rate of completion
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
city: Angers
country: France
facility: ICO Paul Papin
city: Besançon
country: France
facility: CHU Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Cholet
country: France
facility: Centre Hospitalier
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Montpellier
country: France
facility: Centre Val d'Aurelle Paul Lamarque
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Institut Cancerologie de l'Ouest
name: Jean-Marie Commer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poirier AL, Kwiatkowski F, Commer JM, D'Aillieres B, Berger V, Mercier M, Bonnetain F. Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial. Trials. 2012 Apr 20;13:39. doi: 10.1186/1745-6215-13-39.