NCT04244955

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

January 24, 2020

Last Update Submit

October 6, 2021

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Evaluation of the most disturbing elements for the child and the main clinical manifestations found.

    30 minutes

  • Collection of the opinion of the caregivers (doctors, nurses) of each patient on the psychic impact of care on the child.

    30 minutes

  • Evaluation of the agreement between the levels of difficulty rated by the child and his caregivers.

    30 minutes

Interventions

Semi-directive interviewsOTHER

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.

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric cancer

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Elodie SAVOURÉ, M.D

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

January 22, 2020

Primary Completion

September 29, 2021

Study Completion

September 29, 2021

Last Updated

October 13, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)