Trials / Recruiting
RecruitingNCT07117058
Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study.
Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study. Short Title: HARMONY-Tool
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 545 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
- Sex
- All
- Age
- 7 Years – 25 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Generalized Anxiety
- Introspective & Anxiety-Prone Patient
- Depression, Anxiety
- Survivors of Childhood Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | New rapid screening tool for anxiety and depressive disorders | New rapid screening tool for anxiety and depressive disorders completed by patient during a regular follow-up consultation |
| DIAGNOSTIC_TEST | SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised) | Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 7-14 years old. |
| DIAGNOSTIC_TEST | HADS (Hospital Anxiety and Depression Scale) | Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 15-25 years old. |
Timeline
- Start date
- 2025-03-18
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2025-08-12
- Last updated
- 2026-03-30
Locations
7 sites across 1 country: France
Source: ClinicalTrials.gov record NCT07117058. Inclusion in this directory is not an endorsement.