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

一项旨在提高患有癌症的青少年和年轻人依从性的定制干预措施的试点可行性试验

• 批准号: 10583840
• 负责人: Meghan Eileen McGrady
• 金额: $ 25.96万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-12 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10583840
• 关键词: Address; Adherence; Adolescent and Young Adult; Adolescent and young adult cancer patients; Age; Algorithms; Caring; Cause of Death; Cessation of life; Child; Clinical; Country; Data; Disease; Disparity; Dose; Economics; Elderly; Enrollment; Failure; Feedback; Future; Grant; Health; Health Technology; Health behavior; Income; Intervention; Knowledge; Literature; Malignant Childhood Neoplasm; Malignant Neoplasms; Maps; Medical; Modeling; Monitor; National Cancer Institute; Oncology; Outcome; Patients; Pharmaceutical Preparations; Phase; Pilot Projects; Play; Prevalence; Process; Professional Organizations; Protocols documentation; Quality of life; Randomized; Recommendation; Research; Science; Site; Standardization; Survival Rate; Techniques; Testing; Treatment Failure; Treatment Protocols; Tumor Biology; United States; Video Games; age group; age related; arm; behavior change; cancer care; cancer therapy; design; feasibility testing; feasibility trial; forgetting; improved; innovation; insight; interest; mHealth; medication compliance; medication nonadherence; mobile application; mortality; novel; novel strategies; novel therapeutics; oncology program; patient engagement; pilot test; preference; psychoeducation; psychoeducational; randomized, clinical trials; relapse risk; response; standard of care; theories; therapy design; therapy development; tool; treatment effect; trial comparing

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.

项目总结/摘要 高达60%的青少年和年轻人（AYA）癌症患者不依从癌症治疗 因此，复发和死亡的风险增加。作为回应，多名专业人士 一些组织已经认可将药物依从性促进作为儿科癌症护理的标准， AYA肿瘤学项目的重要组成部分。然而，事实证明，提高依从性是困难的， 不同的AYAs和每一个障碍需要一套不同的行为改变技术 （BCT）。尽管需要量身定制，但两种促进依从性的干预措施，包括患有癌症的AYA， 迄今为止，采取了“一刀切”的办法，产生了不显著或较小的治疗效果。这 在建议的护理标准和可用的干预措施之间留下了严重的差距， 坚持。 拟议的研究假设，提供一种干预措施，其中BCT是量身定制的，以解决 考虑到AYA的最大障碍可能有望提高癌症AYA的依从性。直接对准 PAR-19-309呼吁“改善癌症相关健康行为的新策略[即，”，“。 拟议研究的目的是进行一个试点的可行性测试量身定制的坚持促进 对患有癌症的AYA进行干预。这项研究也直接回应了美国国家癌症研究所（National Cancer） 研究所目前对“测试创新干预措施.”的赠款特别感兴趣。优化病人治疗 方案依从性”（NOT-CA-20-026）。 将进行一项试点可行性随机临床试验，将这种定制干预与统一的护理标准进行比较， 进行。来自3个研究中心的共40名癌症AYA将随机分配至定制的依从性促进组 干预或统一护理标准。将收集数据以探讨干预措施 符合预先确定的入组、保留、保真度和数据完成可行性标准，并且AYA将 将干预措施评定为易于使用和可接受。将进行探索性分析， 电子监测药物依从性的潜在组差异。调查结果将用于告知 随后的干预开发和测试阶段。