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ClinicalTrials.gov ID

NCT07117058

Lead Sponsor

Centre Hospitalier Universitaire de Saint EtienneOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

545Estimated

Last Update Posted

Jul 31, 2026Actual

Start Date

Mar 18, 2025Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Sep 2027Estimated

Official Title

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

Brief 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.

• Generalized Anxiety
• Introspective & Anxiety-Prone Patient
• Depression, Anxiety
• Survivors of Childhood Cancer

• New rapid screening tool for anxiety and depressive disorders
• SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)
• HADS (Hospital Anxiety and Depression Scale)

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with pediatric cancer before the age of 18,
• Patient whose intensive treatment had ended at least 3 months prior to inclusion,
• Patients considered to be in complete remission by the doctor responsible for their treatment,
• Patient affiliated to or entitled under a social security scheme,
• Patient having received informed information about the study OR the holder(s) of parental authority having received informed information about the study in the case of minors.

Exclusion Criteria

• Refusal to participate expressed by the patient or minor,
• Patients whose cancer has relapsed or progressed,
• Pregnant women, women in labor, breast-feeding mothers,
• Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than those of the research,
• Adults under legal protection (guardianship) or unable to express their consent.

Observational Model

Other

Time Perspective

Prospective

Lead Sponsor

Centre Hospitalier Universitaire de Saint EtienneOTHER

amandine.bertrand@lyon.unicancer.fr(0)4 69 16 65 50 ext. +33