Study Results
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Basic Information
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TERMINATED
NA
179 participants
INTERVENTIONAL
2011-11-11
2019-06-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A
Patients will complete QoL questionnaires in the following order :
MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month until death
Quality Of Life questionnaires completion
Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.
MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.
Arm B
Patients will complete QoL questionnaires in the following order :
QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month until death
Quality Of Life questionnaires completion
Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.
MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.
Arm C
Patients will complete QoL questionnaires in the following order :
MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month and spontaneous QoL completion, until death
Quality Of Life questionnaires completion
Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.
MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.
Arm D
Patients will complete QoL questionnaires in the following order :
QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month and spontaneous QoL completion, until death.
Quality Of Life questionnaires completion
Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.
MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.
Interventions
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Quality Of Life questionnaires completion
Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.
MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient who can not submit itself to the formal follow-up for psychological, social, family or geographical reasons
18 Years
ALL
No
Sponsors
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Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Principal Investigators
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Jean-Marie Commer, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Cancerologie de l'Ouest
Locations
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CHU
Angers, , France
ICO Paul Papin
Angers, , France
CHU Minjoz
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre Hospitalier
Cholet, , France
Centre Georges François Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Val d'Aurelle Paul Lamarque
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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References
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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.
Related Links
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Sponsor Information
Other Identifiers
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2010-A00196-33
Identifier Type: OTHER
Identifier Source: secondary_id
CPP-435
Identifier Type: -
Identifier Source: org_study_id
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