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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01606033
Other study ID # IPSY 0905
Secondary ID
Status Completed
Phase N/A
First received May 23, 2012
Last updated July 27, 2016
Start date March 2011
Est. completion date February 2014

Study information

Verified date July 2016
Source Centre Oscar Lambret
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date February 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Other:
questionnaires
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey
questionnaire
understanding of the implications of participating in a clinical trial

Locations

Country Name City State
France Paul PAPIN Center Angers
France François Baclesse Center Caen
France CHOLET Hospital Cholet
France Georges-François LECLERC Center Dijon
France Oscar Lambret Center Lille Nord Pas de Calais
France Léon BERARD Center Lyon
France Val D'AURELLE Center Montpellier
France Jean GODINOT Institut Reims

Sponsors (1)

Lead Sponsor Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary measure and compare variation in time of psychological and emotional consequences during treatment emotional regulation (DERS 24) 5 years No
Secondary 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 No
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