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

March 12, 2026 updated by: Centre Oscar Lambret

Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • Paul PAPIN Center
      • Caen, France, 14076
        • François Baclesse Center
      • Cholet, France, 49300
        • Cholet Hospital
      • Dijon, France, 21079
        • Georges-François LECLERC Center
      • Lyon, France, 69373
        • Leon Berard Center
      • Montpellier, France, 34298
        • Val D'AURELLE Center
      • Reims, France, 51056
        • Jean GODINOT Institut
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59020
        • Oscar Lambret Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 WHO (Performance Status) ≤ 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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
Other: 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
Other: 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

What is the study measuring?

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
Time Frame: 4 years
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
Time Frame: 4 years
adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24)
4 years
measure and compare variation in time of psychological and emotional consequences during treatment
Time Frame: 5 years
emotional regulation (DERS 24)
5 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Study Director: Stéphanie CLISANT, Oscar Lambret Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimated)

May 25, 2012

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPSY-0905
  • 2009-A00221-56 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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