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

Not Applicable

Completed

• Conditions: Recurrent Hematologic Cancer; Metastatic Neoplasm
• Interventions: Other: questionnaires; Other: questionnaire

• Registration Number: NCT01606033
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-25
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
phase II non randomized study	questionnaires	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
blind randomized phase II or III study	questionnaire	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
blind randomized phase II or III study	questionnaires	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
receiving standard treatment	questionnaires	receiving standard treatment : 120 patients description of patients feeling by questionnaires : -understanding of the implications of participating in a clinical trial
phase II non randomized study	questionnaire	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
open randomized phase II or III study	questionnaire	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
open randomized phase II or III study	questionnaires	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

Primary Outcome Measures

Name	Time	Method
assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way	4 years	quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)

Secondary Outcome Measures

Name	Time	Method
evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation	4 years	adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24)
measure and compare variation in time of psychological and emotional consequences during treatment	5 years	emotional regulation (DERS 24)
measure the level of knowledge on the implications of participating in a clinical trial (case)	5 years	assess impact of it on psychological and emotional experience

Trial Locations

Locations (8)

Oscar Lambret Center; 🇫🇷 Lille, Nord Pas de Calais, France

Paul PAPIN Center; 🇫🇷 Angers, France

CHOLET Hospital; 🇫🇷 Cholet, France

Georges-François LECLERC Center; 🇫🇷 Dijon, France

Val D'AURELLE Center; 🇫🇷 Montpellier, France

Jean GODINOT Institut; 🇫🇷 Reims, France

François Baclesse Center; 🇫🇷 Caen, France

Léon BERARD Center; 🇫🇷 Lyon, France