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

NCT07117058 | Recruiting

• 2 other identifiers: 23CH1312024-A02404-43
• Study Type: observational
• Target: 545
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

anxiety symptoms; childhood cancer; screening; psychological complication

Outcome Measures

Primary Outcomes (3)

• 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)

  At inclusion

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

  Only for 7-14 years old

  At inclusion

• HADS (Hospital Anxiety and Depression Scale)

  Only 15-25 years old

  At inclusion

Study Arms (3)

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.

Diagnostic Test: New rapid screening tool for anxiety and depressive disorders; Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)

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.

Diagnostic Test: New rapid screening tool for anxiety and depressive disorders; Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)

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.

Diagnostic Test: New rapid screening tool for anxiety and depressive disorders; Diagnostic Test: HADS (Hospital Anxiety and Depression Scale)

Interventions

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.

11-14 years old group; 7-10 years old group

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.

15-25 years old group

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

11-14 years old group; 15-25 years old group; 7-10 years old group

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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,

You may qualify if:

• Patients diagnosed with pediatric cancer before the age of 18,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (7)

Centre Hospitalier Universitaire Caen Normandie

Caen, 14033, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Grenoble, 38043, France

NOT YET RECRUITING

IHOP

Lyon, 69000, France

RECRUITING

CENTRE HOSPITALIER UNIVERSAIRE DE NICE - Hôpital Archet 2

Nice, 06200, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Rouen, 76000, France

NOT YET RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42000, France

RECRUITING

Hopitaux Universitaires de Strasbourg, Hopital Hautepierre

Strasbourg, 67200, France

NOT YET RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depression; Anxiety Disorders; Neoplasms

Interventions

Early Detection of Cancer

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Early Diagnosis; Diagnosis

Study Officials

• CLAIRE BERGER, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CLAIRE BERGER, MD

CONTACT

(0)4.77.12.79.37; claire.berger@chu-st-etienne.fr

Léonie CASAGRANDA, PhD

CONTACT

+33(0)477127937; leonie.casagranda@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (7)