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Cancer End Of Life Evaluation (CEOLE)

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ClinicalTrials.gov Identifier: NCT01545921
Recruitment Status : Unknown
Verified March 2012 by ICO Paul Papin.
Recruitment status was:  Recruiting
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
ICO Paul Papin

Study Description
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545921


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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Additional Information:
Sponsor Information  This link exits the ClinicalTrials.gov site

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

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    Key Record Dates
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