Parents' Insights into Pediatric Oncology Phase I Clinical Trials: Experiences from Their Child's Participation.
OBJECTIVES
Phase 1 clinical trials are essential in the development of novel therapies for childhood cancers. Children with cancer can participate in phase 1 clinical trials when no known curative therapy remains. Understanding the experiences of children and their families in these clinical trials can help ensure that participation supports the children's and parents' well-being. This article explores the specific aspects of pediatric oncology phase 1 trials that parents found particularly challenging.


DATA SOURCES
This qualitative, empirical phenomenology study considered 11 parents' experiences during the time their child with cancer participated in a phase 1 clinical trial. The primary study results were previously reported. This article reports parents' insights into the processes and procedures that occurred as part of participation in a pediatric oncology phase 1 trial.


CONCLUSION
Parents' experiences during the phase 1 clinical trials were primarily positive. However, data analysis revealed five aspects of these trials that were challenging for families: learning about clinical trials, being referred to another institution, research-only procedures, adhering to trial requirements, and oral medications.


IMPLICATIONS FOR NURSING PRACTICE
Although experiences during phase 1 clinical trials were positive overall, opportunities to enhance children's and parents' experiences warrant attention. Enhancing the education provided to families during recruitment and minimizing the logistical burdens associated with trial requirements through care coordination may alleviate challenges experienced by children and parents.
['Crane|Stacey|S|', 'Croop|James M|JM|', 'Lee|Jill|J|', 'Walski|Jamie|J|', 'Haase|Joan|J|']
D002648:Child D006801:Humans D008495:Medical Oncology D009369:Neoplasms D010290:Parents D011368:Professional-Family Relations D036301:Qualitative Research
Parents Child Phase 1 clinical trials Cancer Phenomenology Research participation