Cancer End Of Life Evaluation (CEOLE)
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Other: Quality Of Life questionnaires completion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer |
- Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
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)
- Change in Quality of Life at different times [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]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.
- Number of spontaneous questionnaire completions [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]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.
- Rate of completion [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 402 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01545921
| 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 |
| 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 | |
| Principal Investigator: | Jean-Marie Commer, MD | ICO Paul Papin |
More Information
Additional Information:
No publications provided by ICO Paul Papin
Additional 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 |
| Study First Received: | March 16, 2011 |
| Last Updated: | March 6, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by ICO Paul Papin:
|
Quality Of Life Cancer End of life palliative setting |
ClinicalTrials.gov processed this record on February 27, 2015