ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01606033
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Metastatic Neoplasm Recurrent Hematologic Cancer Other: questionnaires Other: questionnaire Not Applicable

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 Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials
Study Start Date : March 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
phase II non randomized study

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
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

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
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

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
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

receiving standard treatment : 120 patients description of patients feeling by questionnaires :

-understanding of the implications of participating in a clinical trial

 Other: questionnaires
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way [ Time Frame: 4 years ]
    quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)


Secondary Outcome Measures :
  1. 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 ]
    adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24)

  2. measure and compare variation in time of psychological and emotional consequences during treatment [ Time Frame: 5 years ]
    emotional regulation (DERS 24)

  3. measure the level of knowledge on the implications of participating in a clinical trial (case) [ Time Frame: 5 years ]
    assess impact of it on psychological and emotional experience


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606033


Locations
France
Oscar Lambret Center
Lille, Nord Pas de Calais, France, 59020
Paul PAPIN Center
Angers, France, 49033
François Baclesse Center
Caen, France, 14076
CHOLET Hospital
Cholet, France, 49300
Georges-François LECLERC Center
Dijon, France, 21079
Léon BERARD Center
Lyon, France, 69373
Val D'AURELLE Center
Montpellier, France, 34298
Jean GODINOT Institut
Reims, France, 51056
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Stéphanie CLISANT Oscar Lambret Center
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01606033     History of Changes
Other Study ID Numbers: IPSY 0905
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
 Hematologic Diseases
Neoplastic Processes
Pathologic Processes