Psihogios Alexandra M, Rabbi Mashfiqui, Ahmed Annisa, McKelvey Elise R, Li Yimei, Laurenceau Jean-Philippe, Hunger Stephen P, Fleisher Linda, Pai Ahna Lh, Schwartz Lisa A, Murphy Susan A, Barakat Lamia P
Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States.
Department of Statistics, Harvard University, Boston, MA, United States.
JMIR Res Protoc. 2021 Oct 22;10(10):e32789. doi: 10.2196/32789.
Adolescents and young adults (AYAs) with cancer demonstrate suboptimal oral chemotherapy adherence, increasing their risk of cancer relapse. It is unclear how everyday time-varying contextual factors (eg, mood) affect their adherence, stalling the development of personalized mobile health (mHealth) interventions. Poor engagement is also a challenge across mHealth trials; an effective adherence intervention must be engaging to promote uptake.
This protocol aims to determine the temporal associations between daily contextual factors and 6-mercaptopurine (6-MP) adherence and explore the proximal impact of various engagement strategies on ecological momentary assessment survey completion.
At the Children's Hospital of Philadelphia, AYAs with acute lymphoblastic leukemia or lymphoma who are prescribed prolonged maintenance chemotherapy that includes daily oral 6-MP are eligible, along with their matched caregivers. Participants will use an ecological momentary assessment app called ADAPTS (Adherence Assessments and Personalized Timely Support)-a version of an open-source app that was modified for AYAs with cancer through a user-centered process-and complete surveys in bursts over 6 months. Theory-informed engagement strategies will be microrandomized to estimate the causal effects on proximal survey completion.
With funding from the National Cancer Institute and institutional review board approval, of the proposed 30 AYA-caregiver dyads, 60% (18/30) have been enrolled; of the 18 enrolled, 15 (83%) have completed the study so far.
This protocol represents an important first step toward prescreening tailoring variables and engagement components for a just-in-time adaptive intervention designed to promote both 6-MP adherence and mHealth engagement.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32789.
患有癌症的青少年和青年（AYA）口服化疗的依从性欠佳，这增加了癌症复发的风险。目前尚不清楚日常随时间变化的情境因素（如情绪）如何影响他们的依从性，这阻碍了个性化移动健康（mHealth）干预措施的开发。参与度低也是移动健康试验面临的一个挑战；有效的依从性干预措施必须具有吸引力以促进其应用。
本方案旨在确定每日情境因素与6-巯基嘌呤（6-MP）依从性之间的时间关联，并探讨各种参与策略对生态瞬时评估调查完成情况的近端影响。
在费城儿童医院，正在接受包括每日口服6-MP的延长维持化疗的急性淋巴细胞白血病或淋巴瘤的AYA及其配对的照顾者符合条件。参与者将使用一款名为ADAPTS（依从性评估和个性化及时支持）的生态瞬时评估应用程序——这是一款开源应用程序的版本，通过以用户为中心的过程为患有癌症的AYA进行了修改——并在6个月内分阶段完成调查。基于理论的参与策略将进行微观随机化，以估计对近端调查完成情况的因果效应。
在获得美国国立癌症研究所的资助并得到机构审查委员会的批准后，在拟招募的30对AYA-照顾者二元组中，60%（18/30）已被纳入研究；在已纳入的18对中，到目前为止有15对（83%）完成了研究。
本方案是朝着预先筛选用于即时自适应干预的定制变量和参与组件迈出重要的第一步，该干预旨在促进6-MP依从性和移动健康参与度。
国际注册报告识别号（IRRID）：DERR1-10.2196/32789。
