1 Indiana University-Purdue University Indianapolis, Research in Palliative and End-of-Life Communication and Training (RESPECT) Signature Center, Indianapolis, Indiana, USA.
Qual Health Res. 2019 Apr;29(5):632-644. doi: 10.1177/1049732318766513. Epub 2018 Apr 11.
Children with cancer are only eligible for phase I clinical trials (P1Ts) when no known curative therapy remains. However, the primary aims of P1Ts are not focused on directly benefiting participants. This raises ethical concerns that can be best evaluated by exploring the experiences of participants. An empirical phenomenology study, using an adapted Colaizzi method, was conducted of 11 parents' lived experiences of their child's participation in a pediatric oncology P1T. Study findings were that parents' experiences reflected what it meant to have a child fighting to survive high-risk cancer. Although elements specific to P1T participation were identified, more pervasive was parents' sense of running out of time to find an effective treatment and needing to use time they had with their child well. Even though some problems were identified, overall parents did not regret their child's P1T participation and would recommend P1Ts to other parents of children with cancer.
当没有已知的治愈疗法时，患有癌症的儿童才有资格参加 I 期临床试验（P1T）。然而，P1T 的主要目的并不是直接使参与者受益。这引发了一些伦理问题，而通过探索参与者的经验可以最好地评估这些问题。本研究采用修正后的 Colaizzi 方法，对 11 位父母的亲身体验进行了实证现象学研究，这些父母的孩子参与了儿科肿瘤学 P1T。研究结果表明，父母的经历反映了他们的孩子为了生存而与高危癌症作斗争的意义。尽管确定了与 P1T 参与相关的特定元素，但更普遍的是父母感到找到有效治疗方法的时间紧迫，需要充分利用与孩子在一起的时间。尽管发现了一些问题，但总体而言，父母并不后悔孩子参加 P1T，并且会向其他癌症患儿的父母推荐 P1T。
