Cancer End Of Life Evaluation (CEOLE)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Advanced Cancer	Other: Quality Of Life questionnaires completion	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	402 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer
Study Start Date :	December 2010
Estimated Primary Completion Date :	November 2013
Estimated Study Completion Date :	April 2014

Arms and Interventions

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Arm	Intervention/treatment
No Intervention: Arm A; Patients will complete QoL questionnaires in the following order : MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month until death	Other: 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.
No Intervention: Arm B; Patients will complete QoL questionnaires in the following order : QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month until death	Other: 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.
No Intervention: 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	Other: 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.
No Intervention: 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.	Other: 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.

Outcome Measures

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Primary Outcome Measures :

1. Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI) [ Time Frame: Up to 3 years ]

   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)

Secondary Outcome Measures :

1. Change in Quality of Life at different times [ Time Frame: Up to 3 years ]
   Every month or more, QUALE, MVQOLI and QLQ-C15-PAL will be completed by patient, a final score will be calculated and compared at different times.
2. Number of spontaneous questionnaire completions [ Time Frame: Up to 3 years ]
   In arms C and D, patients can complete QLQ-C15-PAL and MVQOLI questionnaires at home if they need it. The number of spontaneous questionnaires completions will be evaluated and the impact on quality of life assessed thanks to calculated score.
3. Rate of completion [ Time Frame: Up to 3 years ]
   Every month or more, the 3 questionnaires QUALE, MVQOLI and QLQ-C15-PAL have to be completed by patient. The rate of completion will be calculated.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Virginie Berger, MD, PhD	33 2 41 35 27 34	virginie.berger@ico.unicancer.fr
Contact: Jessy Delaye, M Sc	33 2 41 35 29 31	jessy.delaye@ico.unicancer.fr

Locations

France
CHU	Recruiting
Angers, France, 49933
Contact: Emilie Le Pape, MD EmLepape@chu-angers.fr
Principal Investigator: Emilie Le Pape, MD
ICO Paul Papin	Recruiting
Angers, France, 49933
Contact: Jean-Marie Commer, MD jean-marie.commer@ico.unicancer.fr
Principal Investigator: Jean-Marie Commer, MD
CHU Minjoz	Not yet recruiting
Besançon, France, 25030
Contact: Didier Faivre Chalon, MD didierfaivrechalon@chu-besancon.fr
Principal Investigator: Régis Aubry, MD
Institut Bergonié	Recruiting
Bordeaux, France, 33076
Contact: Gérard Guesdon, MD Guesdon@bergonie.org
Principal Investigator: Gérard Guesdon, MD
Centre Hospitalier	Recruiting
Cholet, France, 49325
Contact: You Heng Lam, MD you.lam@ch-cholet.fr
Principal Investigator: You Heng Lam, MD
Centre Georges François Leclerc	Recruiting
Dijon, France, 21079
Contact: Laure Favier, MD LFavier@cgfl.fr
Principal Investigator: Laure Favier, MD
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Contact: Stéphanie Villet, MD s-villet@o-lambret.fr
Principal Investigator: Stéphanie Villet, MD
Centre Val d'Aurelle Paul Lamarque	Recruiting
Montpellier, France, 34298
Contact: Jacques Goineau, MD jgoineau@valdorel.fnclcc.fr
Principal Investigator: Jacques Goineau, MD
Centre Antoine Lacassagne	Recruiting
Nice, France, 06189
Contact: Jérôme Barrière, MD jerome.barriere@nice.fnclcc.fr
Principal Investigator: Jérôme Barrière, MD
Centre Alexis Vautrin	Not yet recruiting
Vandoeuvre les Nancy, France, 54511
Contact: Sophie Toussaint Martel, MD s.toussaint@nancy.unicancer.fr
Principal Investigator: Sophie Toussaint Martel, MD

Sponsors and Collaborators

ICO Paul Papin

Investigators

Principal Investigator:	Jean-Marie Commer, MD	ICO Paul Papin

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Sponsor Information 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Poirier AL, Kwiatkowski F, Commer JM, D'Aillières 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.

Responsible Party:	ICO Paul Papin
ClinicalTrials.gov Identifier:	NCT01545921 History of Changes
Other Study ID Numbers:	CPP-435; 2010-A00196-33 ( Other Identifier: French Health Products Safety Agency )
First Posted:	March 7, 2012
Last Update Posted:	March 7, 2012
Last Verified:	March 2012

Keywords provided by ICO Paul Papin:

Quality Of Life; Cancer; End of life; palliative setting