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

This study is currently recruiting participants.
Verified May 2012 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01606033
First received: May 23, 2012
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention
Metastatic Solid Tumor
Recurrent Hematologic Cancer
 Other: questionnaires
Other: questionnaire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)


Secondary Outcome Measures:
  • evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24)

  • measure and compare variation in time of psychological and emotional consequences during treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    emotional regulation (DERS 24)

  • measure the level of knowledge on the implications of participating in a clinical trial (case) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    assess impact of it on psychological and emotional experience


Estimated Enrollment: 240
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
phase II non randomized study
40 patients
 Other: questionnaires
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey
Other: questionnaire
understanding of the implications of participating in a clinical trial
blind randomized phase II or III study
40 patients
 Other: questionnaires
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey
Other: questionnaire
understanding of the implications of participating in a clinical trial
open randomized phase II or III study
40 patients
 Other: questionnaires
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey
Other: questionnaire
understanding of the implications of participating in a clinical trial
receiving standard treatment
120 patients
 Other: questionnaires
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606033

Contacts
Contact: Yvette VENDEL +33 (0) 3.20.29.59.18 y-vendel@o-lambret.fr

Locations
France
Oscar Lambret Center Recruiting
Lille, Nord Pas de Calais, France, 59020
Contact: Yvette VENDEL     +33 (0) 3.20.29.59.18     y-vendel@o-lambret.fr    
Principal Investigator: Nicolas PENEL, MD            
Sub-Investigator: Jacques BONNETERRE, MDPhD            
Sub-Investigator: Antoine ADENIS, MD PhD            
Sub-Investigator: Armelle CATY, MD            
Sub-Investigator: Annick CHEVALIER-PLACE, MD            
Sub-Investigator: Eric DANSIN, MD            
Sub-Investigator: Sophie DOMINGEZ, MD            
Sub-Investigator: Dominique HOGUET, MD            
Sub-Investigator: Alain JOVENIAUX, MD            
Sub-Investigator: Anne LESOIN, MD            
Sub-Investigator: Véronique SERVENT, MD            
Sub-Investigator: Marie VANHUYSE, MD            
Sub-Investigator: Laurence VANLEMMENS, MD            
Sub-Investigator: Edith VANLERENBERGHE, MD            
Sub-Investigator: Philippe VENNIN, MD            
Sub-Investigator: Fabienne WATTELLE, MD            
Paul PAPIN Center Recruiting
Angers, France, 49033
Contact: Philippe MAILLART, MD     + 33 (0) 2.41.35.2934     p.maillart@unimedia.fr    
Principal Investigator: Philippe MAILLART, MD            
Sub-Investigator: Virginie BERGER, MD            
Sub-Investigator: Olivier CAPITAIN, MD            
Sub-Investigator: Jean-Marie COMMER, MD            
Sub-Investigator: Rémy DELVA, MD            
Sub-Investigator: Véronique GUERIN-MEYER, MD            
Sub-Investigator: Patrick SOULIE, MD            
François Baclesse Center Recruiting
Caen, France, 14076
Contact: Florence JOLY-LOBBEDEZ, MD     +33 (0) 2.31.45.51.44     f.joly@baclesse.fr    
Principal Investigator: Florence JOLY6LOBBEDEZ, MD            
Sub-Investigator: Radj GERVAIS, MD            
Sub-Investigator: Floriane TOUDIC-EMILY, MD            
Sub-Investigator: Katharina GUNZER, MD            
CHOLET Hospital Recruiting
Cholet, France, 49300
Contact: Denis MARTIN     +33 (0) 2.41.49.60.00     denis.martin@ch-cholet.fr    
Principal Investigator: Medhi KAASIS, MD            
Sub-Investigator: Julien BAUDON, MD            
Sub-Investigator: You-Heng LAM, MD            
Sub-Investigator: Philippe MASSON, MD            
Georges-François LECLERC Center Recruiting
Dijon, France, 21079
Contact: Laure FAVIER, MD     +33 (0) 3.80.73.77.52     lfavier@dijon.fnclcc.fr    
Principal Investigator: Laure FAVIER, MD            
Sub-Investigator: Bruno COUDERT, MD            
Sub-Investigator: Gilles TRUC, MD            
Sub-Investigator: Rachel DAMERON, MD            
Sub-Investigator: Martine AUBERT, MD            
Léon BERARD Center Recruiting
Lyon, France, 69373
Contact: Olivier TREDAN, MD     +33 (0) 4.78.78.26.44     tredan@lyon.fnclcc.fr    
Principal Investigator: Olivier TREDAN, MD            
Sub-Investigator: Thomas BACHELOT, MD            
Sub-Investigator: Jean-Yves BLAY, MD            
Sub-Investigator: Jérôme FAYETTE, MD            
Sub-Investigator: Aude FLECHON, MD            
Sub-Investigator: Jean-Paul GUASTALLA, MD            
Sub-Investigator: Isabelle RAY-COQUARD, MD            
Sub-Investigator: Paul REBATTU, MD            
Sub-Investigator: Catherine SEBBAN, MD            
Sub-Investigator: Eve Marie NEIDHARDT, MD            
Val D'AURELLE Center Recruiting
Montpellier, France, 34298
Contact: Jean Pierre BLEUSE, MD     +33 (0) 4.67.61.31.02     jean-pierre.bleuse@valdorel.fnclcc.fr    
Principal Investigator: Jean-Pierre BLEUSE, MD            
Sub-Investigator: Michel FABBRO, MD            
Sub-Investigator: William JACOT, MD            
Sub-Investigator: Gilles ROMIEU, MD            
Sub-Investigator: Marc YCHOU, MD            
Sub-Investigator: Eric ASSENAT, MD            
Antoine Lacassagne Center Recruiting
Nice, France, 06189
Contact: Jean-Marc FERRERO, MD PhD         jean-marc.ferrero@cal.nice.fnclcc.fr    
Principal Investigator: Jean-Marc FERRERO, MD PhD            
Sub-Investigator: Philippe FOLLANA, MD            
Sub-Investigator: Christophe HEBERT, MD            
Sub-Investigator: Véronique MARI, MD            
Jean GODINOT Institut Recruiting
Reims, France, 51056
Contact: Jean-Christophe CHARPENTIER     +33 (0) 3.26.50.44.44     jean-christophe.charpentier@reims.fnclcc.fr    
Principal Investigator: Hervé CURE, MD            
Sub-Investigator: Jean-Christophe EYMARD, MD            
Sub-Investigator: Alexia AFONSO, MD            
Sub-Investigator: Brigitte COSTA, MD            
Sub-Investigator: Olivier DUBROEUCQ, MD            
Sub-Investigator: Christelle JOUANNAUD, MD            
Sub-Investigator: Nicolas JOVENIN, MD            
Sub-Investigator: Daniela LEBRUN, MD            
Sub-Investigator: Stéphane PERIN, MD            
Sub-Investigator: Alain PREVOST, MD            
Sub-Investigator: Gabriel YAZBEK, MD            
Sub-Investigator: Aude-Marie SAVOYE, MD            
Eugène MARQUIS Center Recruiting
Rennes, France, 35042
Contact: Thierry LESIMPLE, MD     +33 (0) 2.99.25.32.32     lesimple@rennes.fnclcc.fr    
Principal Investigator: Thierry LESIMPLE, MD            
Sub-Investigator: Catherine LEROUX, MD            
Sub-Investigator: Elodie VAULEON, MD            
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Stéphanie CLISANT Oscar Lambret Center
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01606033     History of Changes
Other Study ID Numbers: IPSY 0905
Study First Received: May 23, 2012
Last Updated: May 25, 2012
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Centre Oscar Lambret:
stress
Life quality
adjustment strategy
 receiving an antitumor treatment
within a clinical trial (case)
according to a standard treatment (control)

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013