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

Pediatric Cancer Clinical Trial

— IPSYLON  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04244955
• Other study ID #: ET19-292 IPSYLON
• Status: Terminated
• Start date: January 22, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: October 2021
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyze of significant psychological difficulties in children aged 6 to 16	Score at the Child Post-Traumatic Stress Reaction Index (CPTS-RI) questionnaire. A score strictly greater than 24 on the CPTS-RI questionnaire will be considered clinically significant for the primary endpoint	30 minutes
Secondary	Evaluation of the most disturbing elements for the child and the main clinical manifestations found.	Most disturbing elements for the child (since the start of care and in invasive and / or repeated care) and the main clinical manifestations found during the semi-directive interviews, carried out by the child psychiatrist.	30 minutes
Secondary	Collection of the opinion of the caregivers (doctors, nurses) of each patient on the psychic impact of care on the child.	Rating of the level of difficulty similar to the CPTS-RI scale: none, mild, moderate, severe or very severe.	30 minutes
Secondary	Evaluation of the agreement between the levels of difficulty rated by the child and his caregivers.	Measure of agreement between the two evaluations using Kappa coefficient	30 minutes