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NCT Number: NCT07117058

Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study.

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.

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Key information

Conditions

Generalized Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Generalized Anxiety Disorder Introspective & Anxiety-Prone Patient Mental Disorders Neoplasms Survivors of Childhood Cancer

Age range

7 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Caen Normandie, Caen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. New rapid screening tool for anxiety-depressive disorders

    Time frame: At inclusion

    This tools is under construction.

    Items development of this tool is following 3 steps :

    • 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.
    • Content validity : the expert judges method to confirm, supplement, or reduce the initial selection of items are used
    • 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)

  2. SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)

    Time frame: At inclusion

    Only for 7-14 years old

  3. HADS (Hospital Anxiety and Depression Scale)

    Time frame: At inclusion

    Only 15-25 years old

Study contacts

Contact information is provided by the study sponsor or research team.

CLAIRE BERGER, MD

CONTACT

[email protected]

(0)4.77.12.79.37 ext. +33

Léonie CASAGRANDA, PhD

CONTACT

[email protected]

+33(0)477127937

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Acronym: HARMONY-Tool

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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