Clinical trial NCT04244955: Observational Study Evaluating the Psychic Impact of the Diagnostic Announcement and Care for Children Treated for Cancer
Official title: Observational Study Evaluating the Psychic Impact of the Diagnostic Announcement and Care for Children Treated for Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pediatric Cancer
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 5
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric cancer

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analyze of significant psychological difficulties in children aged 6 to 16
timeFrame: 30 minutes
Secondary outcomes:
measure: Evaluation of the most disturbing elements for the child and the main clinical manifestations found.
timeFrame: 30 minutes
measure: Collection of the opinion of the caregivers (doctors, nurses) of each patient on the psychic impact of care on the child.
timeFrame: 30 minutes
measure: Evaluation of the agreement between the levels of difficulty rated by the child and his caregivers.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Elodie SAVOURÉ, M.D
role: PRINCIPAL_INVESTIGATOR
References: