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

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: Metastatic Neoplasm; Recurrent Hematologic Cancer
• Intervention / Treatment: Other: questionnaires; Other: questionnaire

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

Study Locations

• France
  • Angers, France, 49033
    • Paul PAPIN Center
  • Caen, France, 14076
    • Francois 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
  • Nord Pas de Calais
    • Lille, Nord Pas de Calais, France, 59020
      • Oscar Lambret Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

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	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

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Investigators: Study Director: Stéphanie CLISANT, Oscar Lambret Center

Study record dates

Study Major Dates

• Study Start: 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 (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: stress; Life quality; adjustment strategy; receiving an antitumor treatment; within a clinical trial (case); according to a standard treatment (control)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Neoplastic Processes; Hematologic Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: IPSY 0905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO