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

Quality of Life Clinical Trial

— COBEQOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02842294
• Other study ID #: P/2012/151
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2016
• Last updated: July 21, 2016
• Start date: May 2013
• Est. completion date: February 2018

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Marion Jacquin, Msc
• Phone: 0033370632171
• Email: fbonnetain[@]chu-besancon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age> 18years

• metastatic colorectal cancer (non resectable)

• 1st chemotherapy including bevacizuman

Exclusion Criteria:

• treatment contre-indication

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer
• Quality of Life

Intervention

Drug:
• Bevacizumab

Locations

Country	Name	City	State
France	CHRU Besançon	Besançon	Franche Comté

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29)		1 year	No
Secondary	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	No
Secondary	quality-adjusted life years (QALYs) using EQ5D		1 year	No
Secondary	Overall survival		2 years	No
Secondary	Progression Free Survival		1 year	No
Secondary	treatment preference		1 year	No

External Links

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