This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way A case-control study
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
125
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey
understanding of the implications of participating in a clinical trial
Oscar Lambret Center
Lille, Hauts-de-France, France
Paul PAPIN Center
Angers, France
François Baclesse Center
Caen, France
CHOLET Hospital
Cholet, France
assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way
quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)
Time frame: 4 years
evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation
adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24)
Time frame: 4 years
measure and compare variation in time of psychological and emotional consequences during treatment
emotional regulation (DERS 24)
Time frame: 5 years
measure the level of knowledge on the implications of participating in a clinical trial (case)
assess impact of it on psychological and emotional experience
Time frame: 5 years
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Georges-François LECLERC Center
Dijon, France
Léon BERARD Center
Lyon, France
Val D'AURELLE Center
Montpellier, France
Jean GODINOT Institut
Reims, France