Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating (IPSY)
Metastatic Neoplasm, Recurrent Hematologic Cancer
About this trial
This is an interventional supportive care trial for Metastatic Neoplasm focused on measuring stress, Life quality, adjustment strategy, receiving an antitumor treatment, within a clinical trial (case), according to a standard treatment (control)
Eligibility 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
Sites / Locations
- Oscar Lambret Center
- Paul PAPIN Center
- François Baclesse Center
- CHOLET Hospital
- Georges-François LECLERC Center
- Léon BERARD Center
- Val D'AURELLE Center
- Jean GODINOT Institut
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
phase II non randomized study
blind randomized phase II or III study
open randomized phase II or III study
receiving standard treatment
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
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
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
receiving standard treatment : 120 patients description of patients feeling by questionnaires : -understanding of the implications of participating in a clinical trial