{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T06:12:21Z","timestamp":1778739141100,"version":"3.51.4"},"reference-count":32,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T00:00:00Z","timestamp":1778716800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pediatr."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To gain insight into parents\u2019 experiences of the informed consent process and their motivations for participating in a randomized clinical trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u2009.570), Emotional influences (Factor 2;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u2009.308), Influence on decision-making (Factor 3;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u2009.017), and Perceived impact on care in the event of non-participation (Indicator;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u2009.174). The qualitative results illuminate the parents\u2019 motivation for enrollment which comprise three themes: Opportunities and risks associated with new treatment, Contributing to research and helping others, Information and strain in the situation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study contributes to a broader understanding of parents\u2019 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\u2019 comprehension and decision-making during the consent process.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fped.2026.1819033","type":"journal-article","created":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T05:44:20Z","timestamp":1778737460000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Randomized clinical trials and informed consent in pediatric oncology: a Nordic comparative study of parents\u2019 experiences"],"prefix":"10.3389","volume":"14","author":[{"given":"Anna","family":"Schr\u00f6der H\u00e5kansson","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg","place":["Gothenburg, Sweden"]},{"name":"Department of Pediatric Oncology, Queen Silvia Children\u2019s Hospital, Sahlgrenska University Hospital","place":["Gothenburg, Sweden"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann-Christine","family":"Andersson","sequence":"additional","affiliation":[{"name":"J\u00f6nk\u00f6ping Academy for Improvement of Health and Welfare, School of Health and Welfare, J\u00f6nk\u00f6ping University","place":["J\u00f6nk\u00f6ping, Sweden"]},{"name":"Region J\u00f6nk\u00f6ping County","place":["J\u00f6nk\u00f6ping, Sweden"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin","family":"Mellgren","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg","place":["Gothenburg, Sweden"]},{"name":"Department of Pediatric Oncology, Queen Silvia Children\u2019s Hospital, Sahlgrenska University Hospital","place":["Gothenburg, Sweden"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nina","family":"Mogensen","sequence":"additional","affiliation":[{"name":"Department of Pediatric Oncology, Astrid Lindgren Children\u2019s Hospital, Karolinska University Hospital","place":["Stockholm, Sweden"]},{"name":"Department of Women\u2019s and Children\u2019s Health, Childhood Cancer Research Unit, Karolinska Institutet","place":["Stockholm, Sweden"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonas","family":"Abrahamsson","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg","place":["Gothenburg, Sweden"]},{"name":"Department of Pediatric Oncology, Queen Silvia Children\u2019s Hospital, Sahlgrenska University Hospital","place":["Gothenburg, Sweden"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaretha","family":"Stenmarker","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg","place":["Gothenburg, Sweden"]},{"name":"Department of Pediatrics and Futurum, Region Jonkoping County","place":["J\u00f6nk\u00f6ping, Sweden"]},{"name":"Department of Biomedical and Clinical Sciences, Link\u00f6ping University","place":["Link\u00f6ping, Sweden"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2026,5,14]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2023-061539","article-title":"Innovations in cancer treatment of children","volume":"152","author":"Helms","year":"2023","journal-title":"Pediatrics"},{"key":"B2","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1093\/pch\/11.3.148","article-title":"Understanding clinical 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