An observational study in Generalized Anxiety, Introspective & Anxiety-Prone Patient and Depression, Anxiety, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 7 sites in France. Open to participants aged 7 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational
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.
131 studies on the registry are indexed under Generalized Anxiety Disorder; 83 are open to participants now.
This study's planned enrollment of 545 is above the median of 384 across 25 observational studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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,
Exclusion Criteria
Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children cured of childhood cancer.
Diagnostic Test: New rapid screening tool for anxiety and depressive disorders · Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)
Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in adolescents cured of childhood cancer.
Diagnostic Test: New rapid screening tool for anxiety and depressive disorders · Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)
Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in young adults cured of childhood cancer.
Diagnostic Test: New rapid screening tool for anxiety and depressive disorders · Diagnostic Test: HADS (Hospital Anxiety and Depression Scale)
New rapid screening tool for anxiety and depressive disorders completed by patient during a regular follow-up consultation
Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 7-14 years old.
Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 15-25 years old.
New rapid screening tool for anxiety-depressive disorders
This tools is under construction. Items development of this tool is following 3 steps : 1. Identification of dimensions and generation of items : a combination of a deductive method (literature review) and an inductive method (questioning individuals) are used to identify the various dimensions relevant to the early assessment of anxiety and depressive disorders and generate the corresponding items. 2. Content validity : the expert judges method to confirm, supplement, or reduce the initial selection of items are used 3. Response options for content validity : binary response options for questions that are unambiguous are used. 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)
Time frame: At inclusion
SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)
Only for 7-14 years old
Time frame: At inclusion
HADS (Hospital Anxiety and Depression Scale)
Only 15-25 years old
Time frame: At inclusion
Plan to share: Undecided
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Centre Hospitalier Universitaire de Saint Etienne