Study Stopped
End of inclusions without reaching the expected number of patients
Cancer End Of Life Evaluation
CEOLE
Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer
2 other identifiers
interventional
179
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2011
CompletedStudy Start
First participant enrolled
November 11, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2019
CompletedAugust 1, 2023
November 1, 2020
7.6 years
March 16, 2011
July 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI)
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)
Up to 3 years
Secondary Outcomes (3)
Change in Quality of Life at different times
Up to 3 years
Number of spontaneous questionnaire completions
Up to 3 years
Rate of completion
Up to 3 years
Study Arms (4)
Arm A
EXPERIMENTALPatients will complete QoL questionnaires in the following order : MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month until death
Arm B
EXPERIMENTALPatients will complete QoL questionnaires in the following order : QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month until death
Arm C
EXPERIMENTALPatients 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
Arm D
EXPERIMENTALPatients 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.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CHU
Angers, 49933, France
ICO Paul Papin
Angers, 49933, France
CHU Minjoz
Besançon, 25030, France
Institut Bergonié
Bordeaux, 33076, France
Centre Hospitalier
Cholet, 49325, France
Centre Georges François Leclerc
Dijon, 21079, France
Centre Oscar Lambret
Lille, 59020, France
Centre Val d'Aurelle Paul Lamarque
Montpellier, 34298, France
Centre Antoine Lacassagne
Nice, 06189, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Related Publications (1)
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.
PMID: 22520742DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marie Commer, MD
Institut Cancerologie de l'Ouest
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2011
First Posted
March 7, 2012
Study Start
November 11, 2011
Primary Completion
June 6, 2019
Study Completion
June 6, 2019
Last Updated
August 1, 2023
Record last verified: 2020-11