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

NCT ID: NCT07117058

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

545 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-18

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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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

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

New rapid screening tool for anxiety and depressive disorders

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 7-14 years old.

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.

New rapid screening tool for anxiety and depressive disorders

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 7-14 years old.

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.

New rapid screening tool for anxiety and depressive disorders

Intervention Type DIAGNOSTIC_TEST

New rapid screening tool for anxiety and depressive disorders completed by patient during a regular follow-up consultation

HADS (Hospital Anxiety and Depression Scale)

Intervention Type DIAGNOSTIC_TEST

Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 15-25 years old.

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CLAIRE BERGER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Centre Hospitalier Universitaire

Grenoble, , France

Site Status NOT_YET_RECRUITING

IHOP

Lyon, , France

Site Status RECRUITING

Centre Hospitalier Universitaire

Rouen, , France

Site Status NOT_YET_RECRUITING

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Centre Hospitalier Universitaire

Tours, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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CLAIRE BERGER, MD

Role: CONTACT

(0)4.77.12.79.37 ext. +33

Léonie CASAGRANDA, PhD

Role: CONTACT

+33(0)477127937

Facility Contacts

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ANNE PAGNIER, MD

Role: primary

(0)476765893 ext. +33

AMANDINE BERTRAND-REYNAUD, MD

Role: primary

(0)4 69 16 65 50 ext. +33

AUDE MARIE-CARDINE, MD

Role: primary

(0)232880714 ext. +33

JULIEN LEJEUNE, MD

Role: primary

(0)2474747 ext. +33

Other Identifiers

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2024-A02404-43

Identifier Type: OTHER

Identifier Source: secondary_id

23CH131

Identifier Type: -

Identifier Source: org_study_id

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