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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00221-56 | Other Identifier | ANSM |
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This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phase II non randomized study | Other | phase II non randomized study, "Case" : 40 patients description of patients feeling by questionnaires :
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| blind randomized phase II or III study | Other | blind randomized phase II or III study: "control" : 40 patients description of patients feeling by questionnaires :
|
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| open randomized phase II or III study | Other | 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 | Other | receiving standard treatment : 120 patients description of patients feeling by questionnaires : -understanding of the implications of participating in a clinical trial |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires | Other | Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| measure and compare variation in time of psychological and emotional consequences during treatment |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphanie CLISANT | Oscar Lambret Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oscar Lambret Center | Lille | Hauts-de-France | 59020 | France | ||
| Paul PAPIN Center |
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|
| questionnaire | Other | understanding of the implications of participating in a clinical trial |
|
emotional regulation (DERS 24) |
| 5 years |
| 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 |
| Angers |
| 49033 |
| France |
| François Baclesse Center | Caen | 14076 | France |
| CHOLET Hospital | Cholet | 49300 | France |
| Georges-François LECLERC Center | Dijon | 21079 | France |
| Léon BERARD Center | Lyon | 69373 | France |
| Val D'AURELLE Center | Montpellier | 34298 | France |
| Jean GODINOT Institut | Reims | 51056 | France |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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