Cancer End Of Life Evaluation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer

Conditions
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Advanced Cancer

Intervention / Treatment
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* Other: Quality Of Life questionnaires completion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>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<br>* 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.<br>|
| Experimental: Arm B<br>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<br>* 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.<br>|
| Experimental: Arm C<br>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<br>* 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.<br>|
| Experimental: Arm D<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life at different times | 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. | Up to 3 years | 
| Number of spontaneous questionnaire completions | 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. | Up to 3 years | 
| Rate of completion | 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. | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality Of Life, Cancer, End of life, palliative setting