ArticleFrontiers in pediatrics2026
Randomized clinical trials and informed consent in pediatric oncology: a Nordic comparative study of parents' experiences.
Article in Frontiers in pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
Background: In pediatric oncology, randomized clinical trials are an integral part of standard treatment. Because enrollment typically must occur before therapy begins, families receive trial information shortly after diagnosis and must provide consent within a brief time frame. The informed consent process therefore often takes place while parents are experiencing emotional stress, have limited medical knowledge, and have little opportunity to reflect on or discuss the available treatment options, as stipulated by good clinical practice. Objective: To gain insight into parents' experiences of the informed consent process and their motivations for participating in a randomized clinical trial. Methods: A Nordic survey using a study-specific questionnaire was conducted. Parents of children enrolled in the NOPHO-DBH AML 2012 and B-NHL 2013 protocols responded. A multimethod approach was applied. Quantitative data were analyzed using descriptive statistics and factor analysis, while qualitative data were analyzed thematically. Results: In total, parents of 72 children (60 single mothers, 32 single fathers, and 8 couples) participated, yielding 100 complete questionnaires. The two protocol groups were similar in sample size, with 49 participants from AML 2012 and 51 from B NHL 2013. Factor analysis identified three factors and one single-item indicator. No statistically significant differences were found between the protocols for any of the variables examined: Influence of information provided (Factor 1; Conclusion: This study contributes to a broader understanding of parents' experiences of the informed consent process within the context of standard treatment practice in pediatric oncology. Despite making decisions under considerable emotional pressure, most parents reported satisfaction with the information provided and did not express regret regarding their enrollment decision. The findings underscore the importance of communication practices that support parents' comprehension and decision-making during the consent process.
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