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Parents’ and children’s comprehension and decision in a paediatric early phase oncology trial: a prospective study

Abstract

Objective To analyse parents’ and children’s understanding of consent information and assess their decision-making process in paediatric oncology.

Design Prospective observational study.

Settings Eleven French paediatric oncology units.

Patients Parents and children who have been asked to give consent for participation in an early phase trial.

Interventions Thirty-seven children and 119 parents were questioned using an audio-recorded semistructured interview.

Main outcome measures The participants’ understanding of nine elements of the informed consent was assessed by comparing their answers with the informed consent leaflet. Their decision-making process was also evaluated.

Results Most parents and children had an excellent understanding regarding their participation in a clinical trial (respectively 88.2% and 48.6%), the right to withdraw (76.5% and 43.2%) and the prospects of collective benefits (74.8% and 48.6%). By contrast, less than half of the parents and few of the children correctly understood the alternatives (respectively 47.5% and 27%), the risks related to participation (44.5% and 10.8%), the prospects of individual benefits (33.6% and 10.8%) and the purpose of the clinical trial (12.6% and 2.7%). Twenty-six (70.3%) children participated in the decision-making process. Most parents and children felt they had no choice but to participate in the trial to have access to a new anticancer treatment.

Conclusions What might appear to be a poor understanding of the research protocol may actually correspond to the families’ interpretation of the situation as a coping mechanism. All children (except infants) should get age-tailored information in order for them to have a meaningful involvement in research.

  • information
  • research protocols
  • communication
  • understanding
  • consent

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