Well-Being of Child and Family Participants in Phase 1 Pediatric Oncology Clinical Trials

Abstract

PROBLEM IDENTIFICATION: Pediatric oncology phase 1 clinical trials (P1Ts) are essential to developing new anticancer therapies; however, they raise complex ethical concerns about balancing the need for this research with the well-being of participating children. The purpose of this integrative review was to synthesize and appraise the evidence of how P1T participation, which begins with consent and ends with the transition off the P1T, can affect the well-being (either positively or negatively) of children with cancer. The Resilience in Individuals and Families Affected by Cancer Framework, which has an outcome of well-being, was used to synthesize findings. LITERATURE SEARCH: Articles on the experiences of child (n = 21) and adult (n = 31) P1T participants were identified through systematic searches. DATA EVALUATION: Articles were evaluated on rigor and relevance to P1T participant experiences as high, medium, or low. SYNTHESIS: Minimal empirical evidence was found regarding the effect of P1T participation on the well-being of children with cancer. Adult P1T participant experiences provide insights that could also be important to children's P1T experiences. IMPLICATIONS FOR PRACTICE: To achieve a balanced approach in P1T consent discussions, nurses and healthcare providers who work with children considering participation in a P1T should share the potential effect of participation on participants' well-being.