Cohort Study to Assess Impact of Chemotherapy Plus Bevacizumab on Health Related Quality of Life in First Line Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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The primary aim of this french multicenter national study is to assess and compare time to quality of life score deterioration (targeted dimensions : global health, fatigue and emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated with bevacizumab in metastatic colorectal patients.

Official Title
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Etude de Cohorte évaluant l'Impact de l'Association chimiothérapie et Bevacizumab en 1ère Ligne du Cancer Colorectal métastatique Sur la qualité de Vie Relative Des Patients. Etude COBEQOL

Conditions
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Metastatic Colorectal Cancer, Quality of Life

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age> 18years metastatic colorectal cancer (non resectable) 1st chemotherapy including bevacizuman Exclusion Criteria: treatment contre-indication

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| irinotecan based chemotherapy<br>patients having a 1st line doublet chemotherapy including irinotecan | Drug: Bevacizumab<br> <br> |
| oxaliplatin based chemotherapy<br>patients having a 1st line doublet chemotherapy including oxaliplatin | Drug: Bevacizumab<br> <br> |
| triplet chemotherapy<br>patient having a 1st line triplet chemotherapy including oxaliplatin / irinotecan this cohort was added while primary objective was to compare doublet chemotherapy | Drug: Bevacizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to health related quality of life score deterioration (targeted dimensions of EORTC QLQC30 : global health, fatigue, emotional functioning) | The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29) |  | 1 year | 
| INT PATSAT32 | The EORTC IN-PATSAT32 is a 32-item satisfaction with care questionnaire to measure patients' appraisal of hospital doctors and nurses, as well as aspects of care organisation and services. It addresses technical competence, information provision, interpersonal skills, availability, waiting time, access, comfort and overall care perception | 1 year | 
| quality-adjusted life years (QALYs) using EQ5D |  | 1 year | 
| Overall survival |  | 2 years | 
| Progression Free Survival |  | 1 year | 
| treatment preference |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bevacizumab, health related quality of life