Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating - Full Text View

Purpose

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

Condition	Intervention
Metastatic Neoplasm Recurrent Hematologic Cancer	Other: questionnaires Other: questionnaire


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:

assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
emotional regulation (DERS 24)
measure the level of knowledge on the implications of participating in a clinical trial (case) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
assess impact of it on psychological and emotional experience


Enrollment:	125
Study Start Date:	March 2011
Study Completion Date:	February 2014
Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Centre Oscar Lambret
ClinicalTrials.gov Identifier:	NCT01606033 History of Changes
Other Study ID Numbers:	IPSY 0905
Study First Received:	May 23, 2012
Last Updated:	July 27, 2016
Health Authority:	France: Committee for the Protection of Personnes
Individual Participant Data
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

ClinicalTrials.gov processed this record on September 30, 2016

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