Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating

Study Overview
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Brief Summary
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This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.

Detailed Description
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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

Official Title
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Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials

Conditions
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Metastatic Neoplasm, Recurrent Hematologic Cancer

Intervention / Treatment
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* Other: questionnaires
* Other: questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or targeted therapy evaluated every 2 or 3 cycles; except for clinical trials associating non drug treatment (radiotherapy, surgery...) subject to a 1st, 2nd or 3rd line of antitumor treatment a phase 2 open labeled study, a phase 2 or 3 blind randomised study, a phase 2 or 3 open randomised study, a standard treatment non participating to a clinical trial male or female patients ≥ 18 years of age karnovsky ≥ 70 % or OMS ≤ 2 recovered from prior toxicities social security covered written informed consent given Exclusion Criteria: psychiatric disorders, receiving psychotropic treatment physical or psychological issues forbidden to be included in this study

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: phase II non randomized study<br>phase II non randomized study, Case : 40 patients description of patients feeling by questionnaires : 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 | Other: questionnaires<br>* Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey<br>Other: questionnaire<br>* understanding of the implications of participating in a clinical trial<br>|
| Other: blind randomized phase II or III study<br>blind randomized phase II or III study: control : 40 patients description of patients feeling by questionnaires : 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 | Other: questionnaires<br>* Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey<br>Other: questionnaire<br>* understanding of the implications of participating in a clinical trial<br>|
| Other: open randomized phase II or III study<br>open randomized phase II or III study : 40 patients description of patients feeling by questionnaires : 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 | Other: questionnaires<br>* Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey<br>Other: questionnaire<br>* understanding of the implications of participating in a clinical trial<br>|
| Other: receiving standard treatment<br>receiving standard treatment : 120 patients description of patients feeling by questionnaires : -understanding of the implications of participating in a clinical trial | Other: questionnaires<br>* Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 4 years | 
| measure and compare variation in time of psychological and emotional consequences during treatment | emotional regulation (DERS 24) | 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 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, Life quality, adjustment strategy, receiving an antitumor treatment, within a clinical trial (case), according to a standard treatment (control)