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.

项目摘要/摘要 多达60％的青少年和年轻人（AYA）患有癌症治疗 药物，从而增加救济和死亡的风险。作为回应，多个专业人士 组织已认可药物依从性促进作为儿科癌症护理的标准和 AYA肿瘤学计划的关键组成部分。然而，事实证明，改善的依从性是障碍的困难 在AYA中的依从性不同，每个障碍都需要不同的行为改变技术 （BCT）。尽管需要调整裁缝，但两种依从性促进干预措施，包括与癌症的AYA 迄今为止，采取了“一定程度的全部”方法，并产生了非显着或小的治疗效果。这 在推荐的护理标准和可用干预措施之间留下一个危险的差距 坚持。 拟议的研究假设，对BCT进行量身定制以解决A的干预措施 鉴于Aya的最高障碍可能会有望改善AYAS癌症的依从性。直接对齐 随着Par-19-309的呼吁，“改善与癌症相关的健康行为的新策略（即依从性）”， 拟议的研究的目的是对量身定制的依从性促进进行实行可行性测试 AYA与癌症的干预。拟议的研究还直接回应了国家癌症 研究所目前对“测试创新干预措施的赠款的特殊兴趣……以优化患者治疗 方案依从性”（非CA-20-026）。 比较这种量身定制干预措施与统一护理标准的试验可行性随机临床试验将是 实施。来自3个地点的癌症共有40个AYA将被随机分为量身定制的依从性促进 干预或统一护理标准。将收集数据以探讨干预措施的假设 符合预先建立的入学率，保留率，保真度和数据完成可行性标准，AYAS将会 将干预措施评为易于使用和可接受。将进行探索性分析以评估 电子监控药物依从性的潜在组差异。调查结果将用于告知 干预开发和测试的随后阶段。