Well-Being of Child and Family Participants in Phase 1 Pediatric Oncology Clinical Trials.
Stacey Crane, Joan E Haase, Susan E Hickman
PMID 30118445WHAT IT FOUND
Evidence about well-being in children's phase 1 cancer trials is thin.
Most children's cancer did not improve, but participation can bring hope and support. Nurses need balanced consent, child voice, and attention to burden, unrealistic optimism, and end-of-life planning.
Key findings
01The review found minimal empirical evidence on children's experiences or well-being during phase 1 oncology trials beyond consent processes.
02In pediatric phase 1 oncology trials, most children's cancer did not improve; combined partial and complete response rates were 3.8-9.6%, and prolonged disease stabilization was reported in 17-24.5%.
03Children recently enrolled in a phase 1 trial were aware of their advanced cancer and parents' emotional turmoil, suggesting assent may reflect a wish to ease parental suffering rather than independent desire.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The review found almost no studies that directly asked children about their experience during a phase 1 trial. Many conclusions about children came from adult trial participants, whose experiences may differ. Only one pediatric article from the first search was highly relevant to the review's purpose. The searches were limited to English-language articles with abstracts. Many articles were more than ten years old and may not reflect current molecularly targeted therapies or trial designs. The authors were not blinded to article authors, journal, or publication year when rating relevance and rigor.
Declared interests
No conflict-of-interest statement is provided in the article text; publication types list NIH extramural and non-U.S. government research support.
The easy way to misread this
Do not read this review as showing that phase 1 trials improve children's well-being or survival. The pediatric evidence was minimal, most children's cancer did not improve, and adult findings were included only because pediatric data were scarce and must be interpreted cautiously.