Metastatic Neoplasm Clinical Trial
— IPSYOfficial title:
Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials
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 |
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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 |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret |
France,
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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