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

Metastatic Neoplasm Clinical Trial

— IPSY  

Official title:

Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606033
• Other study ID #: IPSY 0905
• 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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Metastatic Neoplasm
• Neoplasm Metastasis
• Recurrent Hematologic Cancer

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