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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-25
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial 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,

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

545 Participants
are divided into 3 treatment groups
Group A: 7-10 years old group2 interventions
Group B: 11-14 years old group2 interventions
Group C: 15-25 years old group2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Only for 7-14 years old

Time frame
At inclusion
3

HADS (Hospital Anxiety and Depression Scale)

Only 15-25 years old

Time frame
At inclusion

Secondary outcomes

Other outcomes

Sponsors and contacts

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