Re-Engaging AYA Survivors in Cancer-Related Healthcare (REACH): A Sequential Multiple Assignment Randomized Trial (SMART)

项目摘要/摘要 超过80%的被诊断患有癌症的儿童成为长期存活者；然而，70%的儿童发展为慢性或 治疗产生的危及生命的后遗症，通常出现在青壮年。指导方针 建议每年进行长期跟踪护理(LTFU)，以管理和监控晚期效应、复发或新发 癌症(S)。然而，随着年轻成人和幸存者晚期效应风险的增加，幸存者转向以成人为重点 关爱，关爱的参与度直线下降。脱离LTFU让青少年和年轻的成年人幸存者 (Aya)容易受到延迟或管理不善的诊断的影响，并与较低的知识和自我意识有关 管理能力。因此，针对Aya重新参与的干预措施对这一脆弱群体至关重要 人口。为了满足这一关键的干预需求，我们建议REACH(重新接触Aya幸存者 癌症相关医疗)-一项创新的序贯多分配随机试验(SMART) 两阶段设计。我们将利用我们在过渡到成人护理、生存护理计划和数字技术方面的研究 健康干预。阶段1测试低接触干预(LTI)，由提醒“轻推”文本消息组成 和最多4周的信息资源，而增强型常规护理小组将获得 仅限书面信息(WI)。接下来，在第二阶段，将根据对第一阶段的反应情况对阿亚进行重新随机化 (即，无论他们是否预约)进入16周的干预。应急者要么会被重新- 随机接受持续干预(维持)或病情加重，而无应答者 将只会收到一个逐步增加的条件。升级可能包括扩展LTI(更多文本消息)或HIGH 触摸干预(HTI)。HTI包括文本消息和数字资源，包括个性化的 生存护理计划(SCP)，在移动友好平台上，提供针对变量的信息，例如 护理障碍、治疗史和建议，以及个人健康目标。此外，社交 将提供工人和/或护士支持，以帮助克服障碍(例如，无障碍护理)。干预措施 阶段2中的选项旨在增强自我管理，而不仅仅是参加LTFU，以便 保持长期接触。在阶段1(T2)、阶段2(T3)和9个月后测量结果 (T4)。我们预计，那些从LTI开始而不是WI的人将更有可能在T4之前参加LTFU的预约。 对于第二阶段，与接受维持治疗的人相比，接受加重病情的人，以及 与LTI相比，接受HTI的人更有可能在T4之前参加预约。通过以下方式参加预约 T3和自我管理指数是次要结果。我们还将评估干预的主持人 结果、干预参与度、可接受性、可行性和成本。定性访谈将评估 多层障碍和利益攸关方未来实施的促进者(Aya、父母/支持、 提供商、管理员)。此试验响应NOT-CA-22-029和PAR-21-035以促进最佳 参与LTFU和AYA幸存者的自我管理，改善结果和缩小差距。

PROJECT SUMMARY/ABSTRACT Over 80% of children diagnosed with cancer become long-term survivors; however, 70% develop chronic or life-threatening late effects from treatment, and these often emerge during young adulthood. Guidelines recommend annual long-term follow-up care (LTFU) to manage and monitor for late effects, recurrence, or new cancer(s). Yet, as risk for late effects increases in young adulthood and survivors transition into adult-focused care, engagement in care plummets. Disengagement from LTFU leaves adolescent and young adult survivors (AYA) vulnerable to delayed or poorly managed diagnoses, and relates to lower knowledge and self- management abilities. Thus, interventions targeting re-engagement of AYA are critical for this vulnerable population. In order to address this critical intervention need, we propose REACH (Re-Engaging AYA survivors in Cancer-related Healthcare)—an innovative sequential multiple assignment randomized trial (SMART) with a two-stage design. We will leverage our research on transition to adult care, survivorship care plans, and digital health interventions. Stage 1 tests a low touch intervention (LTI), consisting of reminder “nudge” text messages and informational resources for up to 4 weeks compared to an enhanced usual care group that will receive written information (WI) only. Next, in Stage 2, AYA will be re-randomized based on responsiveness to Stage 1 (i.e., whether or not they made an appointment) into 16 weeks of intervention. Responders will either be re- randomized to receive a continued intervention (maintenance) or a stepped-up condition, while non-responders will only receive a stepped-up condition. Step-up may include expanded LTI (more text messages) or a high touch intervention (HTI). The HTI includes text messages and digital resources, including a personalized survivorship care plan (SCP), on a mobile-friendly platform with information tailored to variables such as barriers to care, treatment history and recommendations, and a personal health goal. Additionally, social worker and/or nurse support will be available to help overcome barriers (e.g., access care). The intervention options in Stage 2 are intended to enhance self-management beyond simply attending LTFU in order to sustain long-term engagement. Outcomes are measured after Stage 1 (T2), Stage 2 (T3) and at 9 months (T4). We expect those who start with LTI versus WI will be more likely to attend a LTFU appointment by T4. For Stage 2, those who receive the stepped-up condition compared to those with maintenance, and those who received HTI compared to LTI, will be more likely to attend an appointment by T4. Attending an appointment by T3 and indices of self-management are secondary outcomes. We will also assess moderators of intervention outcomes, intervention engagement, acceptability, feasibility, and cost. Qualitative interviews will assess multilevel barriers and facilitators of future implementation with stakeholders (AYA, parents/supports, providers, administrators). This trial responds to NOT-CA-22-029 and PAR-21-035 to promote optimal engagement in LTFU and self-management for AYA survivors, improving outcomes and reducing disparities.