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

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.

Study Overview

• Status: Terminated
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: Semi-directive interviews

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre Leon Berard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric cancer

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Elodie SAVOURÉ, M.D, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): September 29, 2021
• Study Completion (Actual): September 29, 2021

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ET19-292 IPSYLON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No