Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating (IPSY)
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ClinicalTrials.gov Identifier: NCT01606033 |
Recruitment Status
:
Completed
First Posted
: May 25, 2012
Last Update Posted
: July 28, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Neoplasm Recurrent Hematologic Cancer | Other: questionnaires Other: questionnaire | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
phase II non randomized study
phase II non randomized study, "Case" : 40 patients description of patients feeling by questionnaires :
|
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 :
|
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
|
- 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)
- 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)
- measure and compare variation in time of psychological and emotional consequences during treatment [ Time Frame: 5 years ]emotional regulation (DERS 24)
- 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

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 |
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

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
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 |
Study Director: | Stéphanie CLISANT | Oscar Lambret Center |
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 |