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

L

Léon Bérard Center

Status

Terminated

Conditions

Pediatric Cancer

Treatments

Other: Semi-directive interviews

Study type

Observational

Funder types

Other

Identifiers

NCT04244955
ET19-292 IPSYLON

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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