A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults with Cancer

项目摘要/摘要 高达60%的患有癌症的青少年和年轻人(AYA)不坚持癌症治疗 药物，从而增加复发和死亡的风险。作为回应，多名专业人士 各组织已将促进用药依从性作为儿科癌症护理的标准，并 Aya肿瘤学项目的关键组成部分。然而，作为障碍，提高遵从性被证明是困难的。 对AYA的遵守各不相同，每个障碍需要一套不同的行为改变技术 (BCT)。尽管需要量身定做，但包括癌症AYA在内的两项促进依从性的干预措施 到目前为止，已经采取了“一刀切”的方法，并产生了不显著或很小的治疗效果。这 在建议的护理标准和可供改进的干预措施之间存在严重差距 坚持不懈。 拟议的研究假设，提供一种干预措施，其中BCT是为解决 鉴于AYA的最高障碍可能会为提高AYA癌症患者的依从性带来希望。直接对齐 在PAR-19-309中，S呼吁“采用新策略来改善与癌症相关的健康行为[即，坚持]”， 拟议研究的目的是进行一项量身定制的遵守-促进的试点可行性测试 对患有癌症的AYAS的干预。这项拟议的研究也直接回应了国家癌症 研究所目前对拨款特别感兴趣，这些赠款是“测试创新的干预措施……以优化患者治疗 方案依从性“(非-CA-20-026)。 一项试点可行性随机临床试验将比较这种量身定做的干预和统一的护理标准 指挥。来自3个地点的40名癌症AYA将随机参加量身定做的依从性宣传活动 干预或统一的护理标准。将收集数据来探索干预措施的假设 满足预先确定的登记、保留、保真和数据完成可行性标准，并且AYA将 将干预措施评为易于使用和可接受的。将进行探索性分析以评估 电子监测服药依从性方面的潜在组别差异。调查结果将用于向 干预措施开发和测试的后续阶段。

PROJECT SUMMARY/ABSTRACT Up to 60% of adolescents and young adults (AYAs) with cancer are non-adherent to cancer treatment medications and thus at an increased risk of relapse and death. In response, multiple professional organizations have endorsed medication adherence promotion as a standard of pediatric cancer care and a critical component of AYA oncology programs. Improving adherence, however, has proved difficult as barriers to adherence differ across AYAs and each barrier requires a different set of behavior change techniques (BCTs). Despite this need for tailoring, the two adherence-promotion interventions including AYAs with cancer to date have taken a “one-size-fits-all” approach and produced non-significant or small treatment effects. This leaves a critical gap between the recommended standards of care and available interventions to improve adherence. The proposed research hypothesizes that delivering an intervention in which BCTs are tailored to address a given AYA’s top barriers may hold promise for improving adherence among AYAs with cancer. Directly aligned with PAR-19-309’s call for “novel strategies to improve cancer-related health behaviors [i.e., adherence],” the purpose of the proposed research is to conduct a pilot feasibility test of a tailored adherence-promotion intervention for AYAs with cancer. The proposed research also directly responds to the National Cancer Institute’s current special interest in grants that “test innovative interventions...to optimize patient treatment regimen adherence” (NOT-CA-20-026). A pilot feasibility randomized clinical trial comparing this tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer from 3 sites will be randomized to the tailored adherence-promotion intervention or uniform standard of care. Data will be collected to explore the hypotheses that the intervention meets pre-established enrollment, retention, fidelity, and data completion feasibility criteria and that AYAs will rate the intervention as easy to use and acceptable. Exploratory analyses will be conducted to evaluate potential group differences in electronically-monitored medication adherence. Findings will be used to inform subsequent phases of intervention development and testing.