Observational Study Evaluating the Psychic Impact of the Diagnostic Announcement and Care for Children Treated for Cancer

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

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-22

Study Completion Date

2021-09-29

Brief Summary

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The cancer diagnostic announcement and cancer care are both physical and psychological highlights. The main objective is to analyze significant psychological difficulties in children aged 6 to 16 treated for cancer.

Detailed Description

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Symptoms of post traumatic stress disorder in young children are often underdiagnosed because the criteria of DSM-IV and ICD-10 are not suitable for these children. These symptoms are nightmares, sleep problems, compulsive and joyless gambling, regression, hyper attention, anxiety over new separation, and new fears. It is also known that the disorders are readily more marked at the start of treatment and then subside throughout the first year. Some may appear afterwards after treatment.

To our knowledge, no study has evaluated the prevalence of mental disorders linked to diagnosis and care during treatment and their link with the practice of care. This study will focus on disorders during treatment. We will study the psychic impact of the announcement of diagnosis and care, whether they belong to the traumatic dimension or not. For this, we will use the validated French version of the Child Post-Traumatic Stress Reaction Index (CPTS-RI) scale. It is the most widely used scale in clinical research of trauma and reactive mental disorders in children 6 to 16 years of age. We will also assess the most disturbing elements for the child and the main clinical manifestations found in order to improve the detection of mental disorders and the care support for these children.

This research will allow us to assess the prevalence of mental disorders in connection with the care practiced within the Institute of Pediatric Hematology and Oncology (IHOPe) and, subsequently, to establish a another intervention research protocol to improve our practices and the care of these patients.

Conditions

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Pediatric Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Semi-directive interviews

The interviews, carried out by the child psychiatrist, will be semi-directive and short (15 to 30 minutes) one-on-one with the child or adolescent so that the presence of the parents does not influence the responses. The CPTS-RI index, which has 20 questions, will be filled, as well as other questions to understand what is problematic for the child.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient aged 6 to 16 years;
* Patient diagnosed for a malignant pathology for at least one month and maximum 2 months;
* Patient treated at the IHOPe;
* Non-opposition of the parents and the child under study.

Exclusion Criteria

* Difficulty speaking and understanding French;
* Patient who is not able to express himself because the somatic medical conditions do not allow a verbal exchange.

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elodie SAVOURÉ, M.D

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

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Centre Léon Bérard

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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ET19-292 IPSYLON

Identifier Type: -

Identifier Source: org_study_id