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Original article
Parents’ and children’s comprehension and decision in a paediatric early phase oncology trial: a prospective study
  1. Agathe Béranger1,
  2. Naïm Bouazza1,
  3. Amélie de Haut de Sigy1,
  4. Anne-Charlotte Foubert-Wenc1,
  5. Dominique Davous2,
  6. Isabelle Aerts3,
  7. Birgit Geoerger4,
  8. Anne Auvrignon5,
  9. Benoît Brethon6,
  10. Pierre Leblond7,
  11. Nadège Corradini8,9,
  12. Nicolas André10,11,
  13. Hélène Martinez9,
  14. Jean-Claude K Dupont12,
  15. François Doz3,13,
  16. Hélène Chappuy1,14
  1. 1Unité de recherche clinique, hôpital Cochin-Necker, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, Île-de-France, France
  2. 2CHU Saint Louis, Espace éthique région Ile-de-France, Paris, France
  3. 3Centre Oncologie SIREDO (Soins, Innovation et Recherche pour enfants, adolescents et jeunes adultes atteints de cancer), Institut Curie, Paris, France
  4. 4Département d’oncologie pédiatrique et pour adolescents, Gustave Roussy, Villejuif, France
  5. 5Hémato-Immuno-Oncologie Pédiatrique, hôpital Armand Trousseau, AP-HP, Université Pierre et Marie Curie, Paris, France
  6. 6Hématologie immunologie pédiatrique, hôpital Robert Debré, AP-HP, Université Paris Diderot, Paris, France
  7. 7Oncologie pédiatrique, Centre Oscar Lambret, Centre régional de lutte contre le cancer, Lille, France
  8. 8Service d’hématologie et oncologie pédiatrique, hôpital Mère-Enfant, Nantes, France
  9. 9Institut d’hématologie et d’oncologie pédiatrique (IHOPe), Centre régional de lutte contre le cancer, Centre Léon Bérard, Lyon, France
  10. 10Hématologie et oncologie pédiatrique, hôpital de la Timone, AP-HM, Marseille, France
  11. 11INSERM UMR 911, Centre de recherche en oncologie biologique et en oncopharmacologie, Université Aix-Marseille, Marseille, France
  12. 12Hospinnomics, Paris School of Economics, Assistance Publique-Hôpitaux de Paris, Paris, France
  13. 13Université Paris Descartes, Université Paris Descartes, Paris, France
  14. 14Urgences pédiatriques, hôpital Armand Trousseau, AP-HP, Université Pierre et Marie Curie, Paris, France
  1. Correspondence to Dr. Hélène Chappuy, Urgences pédiatriques, hôpital Armand Trousseau, AP-HP, Université Pierre et Marie Curie, Paris 75012, France; helene.chappuy{at}aphp.fr

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

https://doi.org/10.1136/archdischild-2018-315237

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    Footnotes

    • Contributors AB analysed and interpreted the data, and drafted the initial manuscript. NB analysed the data, and reviewed and revised the manuscript. AdHdS and ACFW contributed to the design of the study, designed the data collection instruments, implemented the study, acquired and analysed the data, and reviewed and revised the manuscript. DD contributed to the design of the study, designed the data collection instruments, and reviewed and revised the manuscript. IA, BG, AA, BB, PL, NC, NA and HM coordinated and supervised the data collection, and reviewed and revised the manuscript. JCKD interpreted the data, and reviewed and revised the manuscript. FD contributed to the design of the study, designed the data collection instruments, coordinated and supervised the data collection, and reviewed and revised the manuscript. CH was the principal investigator of the study, contributed to the design, designed the data collection instruments, implemented the study, coordinated and supervised the data collection, analysed and interpreted the data, and reviewed and revised the manuscript. All authors critically reviewed iterations of the report and approved the final draft for submission.

    • Funding This research has obtained, on request, a funding from the national Hospital Clinical Research Program (AOM06138) in 2006.

    • Competing interests NA reports personal fees and non-financial support from Pierre Fabre, BMS, outside the submitted work. FD reports financial relationships with Novartis, Sandoz, Boehringer Ingelheim, Servier, Roche and Bayer, outside the submitted work. AB, NB, AdHdS, ACFW, DD, IA, BG, AA, BB, PL, NC, HM, JCKD and CH have nothing to disclose.

    • Patient consent Not required.

    • Ethics approval The study was approved by an institutional review board (Necker Hospital Ethics Committee), the French Data Protection Authority (CNIL) and the French National Union of Associations for Parents of Children Suffering from Cancer or Leukemia (UNAPECLE).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Correction notice This paper has been amended since it was published Online First. The corresponding author’s surname was transposed with her first name and this has now been corrected.