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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02404-43 | Other Identifier | ANSM |
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In France today, it is estimated that one in every 850 people aged between 20 and 45 is a childhood cancer survivor (CCS), equivalent to around 40,000 to 50,000 people. Some descriptive studies have established that the diagnosis and treatment of cancer can affect psychological health. A French study published by our team in 2015 and 2020 showed that in adulthood, 40% of CCS had anxiety symptoms, a rate significantly higher than that of the general French population (25%). However, although there are validated scales for screening children for psychological disorders (anxiety, depression, etc.), there is no rapid screening tool that can be used routinely by an oncologist during consultations. So, the study aims to develop and validate a short test, which could easily be carried out systematically during follow-up consultations after childhood cancer. It would make it possible to identify people with no psychological complications and, conversely, those in whom further investigation, based on the classic reference scales for assessing psychological disorders, would be relevant.
The aim of the HARMONY-Tool study is to develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children, adolescents and young adults cured of childhood cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7-10 years old group | Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children cured of childhood cancer. |
| |
| 11-14 years old group | Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in adolescents cured of childhood cancer. |
| |
| 15-25 years old group | Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in young adults cured of childhood cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New rapid screening tool for anxiety and depressive disorders | Diagnostic Test | New rapid screening tool for anxiety and depressive disorders completed by patient during a regular follow-up consultation |
| Measure | Description | Time Frame |
|---|---|---|
| New rapid screening tool for anxiety-depressive disorders | This tools is under construction. Items development of this tool is following 3 steps :
This tool will contain a maximum of 7 questions for children aged 6 to 10, 8 questions for adolescents aged 11 to 14 (in particular because of an additional question on the use of addictive substances) and 10 questions for the 15-25 age group (with the possibility of finer dimensions) | At inclusion |
| SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised) | Only for 7-14 years old | At inclusion |
| HADS (Hospital Anxiety and Depression Scale) | Only 15-25 years old | At inclusion |
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Inclusion Criteria
Exclusion Criteria
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Patients diagnosed with pediatric cancer before the age of 18, whose intensive treatment had ended at least 3 months prior to inclusion and considered to be in complete remission by the doctor responsible for their treatment,
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CLAIRE BERGER, MD | Contact | (0)4.77.12.79.37 | +33 | claire.berger@chu-st-etienne.fr |
| Léonie CASAGRANDA, PhD | Contact | +33(0)477127937 | leonie.casagranda@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| CLAIRE BERGER, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Caen Normandie | Not yet recruiting | Caen | 14033 | France |
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| SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised) | Diagnostic Test | Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 7-14 years old. |
|
| HADS (Hospital Anxiety and Depression Scale) | Diagnostic Test | Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 15-25 years old. |
|
| Centre Hospitalier Universitaire | Not yet recruiting | Grenoble | 38043 | France |
|
| IHOP | Recruiting | Lyon | 69000 | France |
|
| CENTRE HOSPITALIER UNIVERSAIRE DE NICE - Hôpital Archet 2 | Not yet recruiting | Nice | 06200 | France |
|
| Centre Hospitalier Universitaire | Not yet recruiting | Rouen | 76000 | France |
|
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | 42000 | France |
|
| Hopitaux Universitaires de Strasbourg, Hopital Hautepierre | Not yet recruiting | Strasbourg | 67200 | France |
|
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055088 | Early Detection of Cancer |
| ID | Term |
|---|---|
| D042241 | Early Diagnosis |
| D003933 | Diagnosis |
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