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

Primary Purpose

Metastatic Neoplasm, Recurrent Hematologic Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaires
questionnaire
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Neoplasm focused on measuring stress, Life quality, adjustment strategy, receiving an antitumor treatment, within a clinical trial (case), according to a standard treatment (control)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oscar Lambret Center
  • Paul PAPIN Center
  • François Baclesse Center
  • CHOLET Hospital
  • Georges-François LECLERC Center
  • Léon BERARD Center
  • Val D'AURELLE Center
  • Jean GODINOT Institut

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

phase II non randomized study

blind randomized phase II or III study

open randomized phase II or III study

receiving standard treatment

Arm Description

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: "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

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

receiving standard treatment : 120 patients description of patients feeling by questionnaires : -understanding of the implications of participating in a clinical trial

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
measure and compare variation in time of psychological and emotional consequences during treatment
emotional regulation (DERS 24)
measure the level of knowledge on the implications of participating in a clinical trial (case)
assess impact of it on psychological and emotional experience

Full Information

First Posted
May 23, 2012
Last Updated
July 27, 2016
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT01606033
Brief Title
Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating
Acronym
IPSY
Official Title
Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Neoplasm, Recurrent Hematologic Cancer
Keywords
stress, Life quality, adjustment strategy, receiving an antitumor treatment, within a clinical trial (case), according to a standard treatment (control)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
phase II non randomized study
Arm Type
Other
Arm Description
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
Arm Title
blind randomized phase II or III study
Arm Type
Other
Arm Description
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
Arm Title
open randomized phase II or III study
Arm Type
Other
Arm Description
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
Arm Title
receiving standard treatment
Arm Type
Other
Arm Description
receiving standard treatment : 120 patients description of patients feeling by questionnaires : -understanding of the implications of participating in a clinical trial
Intervention Type
Other
Intervention Name(s)
questionnaires
Intervention Description
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey
Intervention Type
Other
Intervention Name(s)
questionnaire
Intervention Description
understanding of the implications of participating in a clinical trial
Primary Outcome Measure Information:
Title
assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way
Description
quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)
Time Frame
4 years
Secondary Outcome Measure Information:
Title
evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation
Description
adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24)
Time Frame
4 years
Title
measure and compare variation in time of psychological and emotional consequences during treatment
Description
emotional regulation (DERS 24)
Time Frame
5 years
Title
measure the level of knowledge on the implications of participating in a clinical trial (case)
Description
assess impact of it on psychological and emotional experience
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie CLISANT
Organizational Affiliation
Oscar Lambret Center
Official's Role
Study Director
Facility Information:
Facility Name
Oscar Lambret Center
City
Lille
State/Province
Nord Pas de Calais
ZIP/Postal Code
59020
Country
France
Facility Name
Paul PAPIN Center
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
François Baclesse Center
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
CHOLET Hospital
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Georges-François LECLERC Center
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Léon BERARD Center
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Val D'AURELLE Center
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Jean GODINOT Institut
City
Reims
ZIP/Postal Code
51056
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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