Metastatic Neoplasm, Recurrent Hematologic Cancer
Conditions
Keywords
stress, Life quality, adjustment strategy, receiving an antitumor treatment, within a clinical trial (case), according to a standard treatment (control)
Brief summary
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.
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
Interventions
OTHERquestionnaires
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey
OTHERquestionnaire
understanding of the implications of participating in a clinical trial
Sponsors
Centre Oscar Lambret
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 WHO (Performance Status) ≤ 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way | 4 years | quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation | 4 years | adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24) |
| measure and compare variation in time of psychological and emotional consequences during treatment | 5 years | emotional regulation (DERS 24) |
| measure the level of knowledge on the implications of participating in a clinical trial (case) | 5 years | assess impact of it on psychological and emotional experience |
Countries
France
Contacts
STUDY_DIRECTORStéphanie CLISANT
Oscar Lambret Center
Outcome results
None listed