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Parents' and children's comprehension and decision in a paediatric early phase oncology trial: a prospective study
Agathe Béranger1, Naïm Bouazza1, Amélie de Haut de Sigy1
1Unité de recherche clinique, hôpital Cochin-Necker, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, Île-de-France, France.
Insights
Parents and children in pediatric oncology trials often misunderstand key consent information like risks and benefits. Tailored, age-appropriate communication is crucial for meaningful child involvement in research decisions.
Area of Science:
- Pediatric Oncology
- Clinical Trial Ethics
- Informed Consent
Background:
- Understanding informed consent is vital for ethical pediatric oncology research.
- Assessing comprehension and decision-making in pediatric oncology trials is complex.
- Previous research highlights challenges in pediatric informed consent processes.
Purpose of the Study:
- To analyze parental and child understanding of consent information in pediatric oncology.
- To evaluate the decision-making process for clinical trial participation in pediatric oncology.
Main Methods:
- Prospective observational study in 11 French pediatric oncology units.
- Semi-structured interviews with 119 parents and 37 children undergoing consent for early-phase trials.
- Assessment of understanding of 9 informed consent elements and evaluation of the decision-making process.
Main Results:
- High parental (88.2%) and child (48.6%) understanding of trial participation, but lower comprehension of risks (44.5% parents, 10.8% children) and benefits (33.6% parents, 10.8% children).
- 70.3% of children participated in decision-making, with many parents/children feeling compelled to enroll for access to novel treatments.
- Significant gaps in understanding alternatives, risks, individual benefits, and trial purpose were observed.
Conclusions:
- Apparent poor understanding may reflect coping mechanisms; age-tailored information is essential for children's meaningful involvement.
- Improving communication strategies is necessary to enhance comprehension of critical consent elements.
- Ensuring genuine shared decision-making requires addressing families' perceptions of choice and access to treatment.
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.