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

让 AYA 幸存者重新参与癌症相关医疗保健 (REACH)：一项序贯多重分配随机试验 (SMART)

• 批准号: 10660360
• 负责人: Lisa A Schwartz
• 金额: $ 75.64万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-21 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10660360
• 关键词: Address; Administrator; Adolescent and Young Adult; Adult; Appointment; Awareness; Cancer Survivorship; Caring; Child; Chronic; Data; Diagnosis; Disparity; Evaluation; Face; Friends; Future; Goals; Guidelines; Health; Health Services Accessibility; Healthcare; Individual; Insurance; Intervention; Intervention Studies; Interview; Knowledge; Knowledge Management; Late Effects; Letters; Life; Long-Term Survivors; Longterm Follow-up; Maintenance; Malignant Childhood Neoplasm; Malignant Neoplasms; Monitor; Morbidity - disease rate; Nurses; Outcome; Outcome Measure; Parents; Personal Satisfaction; Persons; Population; Provider; Randomized; Recommendation; Recording of previous events; Recurrence; Reporting; Research; Resources; Risk; Second Primary Cancers; Self Management; Sequential Multiple Assignment Randomized Trial; Social Work; Social Workers; Specific qualifier value; Standardization; Survivors; System; Technology; Testing; Text Messaging; Time; Touch sensation; Treatment Efficacy; Vulnerable Populations; Work; Writing; adaptive intervention; analytical method; barrier to care; behavioral economics; childhood cancer survivor; clinical care; comparative efficacy; comparison intervention; cost; demographics; design; digital; digital health; digital tool; disparities in morbidity; disparity reduction; follow-up; future implementation; health disparity; health goals; health management; health plan; implementation barriers; implementation cost; implementation facilitators; improved; improved outcome; indexing; innovation; multidisciplinary; outcome disparities; primary outcome; programs; risk stratification; secondary outcome; survivorship; theories; treatment as usual; treatment effect; vulnerable adolescent; young adult

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.

项目概要/摘要 超过 80% 被诊断患有癌症的儿童成为长期幸存者，但 70% 的儿童会发展成慢性或癌症。 治疗带来的危及生命的后期影响，这些影响通常出现在成年早期。 建议每年进行一次长期随访护理 (LTFU)，以管理和监测迟发效应、复发或新的效应 然而，随着成年早期晚期影响的风险增加，幸存者转向以成人为中心。 青少年和年轻的幸存者脱离了 LTFU。 （AYA）容易受到延迟或管理不善的诊断的影响，并且与知识水平较低和自我意识较低有关 因此，针对 AYA 重新参与的干预措施对于这一弱势群体至关重要。 为了满足这一关键的干预需求，我们提议 REACH（重新参与 AYA 幸存者）。 癌症相关医疗保健）——一项创新的序贯多重分配随机试验 (SMART) 我们将利用我们对成人护理过渡、幸存者护理计划和数字化的研究。 第一阶段测试低接触干预（LTI），包括提醒“轻推”短信。 和信息资源长达 4 周，而强化常规护理组将接受 仅书面信息 (WI) 接下来，在第 2 阶段，AYA 将根据对第 1 阶段的反应进行重新随机化。 （即，无论他们是否预约）在 16 周的干预期内，应答者将被重新接受。 随机接受持续干预（维持）或加强条件，而无反应者 只会收到升级条件。升级可能包括扩展的 LTI（更多短信）或高。 触摸干预 (HTI) HTI 包括短信和数字资源，其中包括个性化信息。 幸存者护理计划（SCP），在一个适合移动设备的平台上，提供根据变量定制的信息，例如 护理障碍、治疗史和建议以及个人健康目标。 将提供工作人员和/或护士支持来帮助克服障碍（例如，获得护理）。 第二阶段的选项旨在加强自我管理，而不仅仅是参加 LTFU，以便 维持长期参与的结果是在第 1 阶段 (T2)、第 2 阶段 (T3) 和 9 个月后进行衡量。 (T4)。我们预计那些从 LTI 开始的人比 WI 更有可能在 T4 之前参加 LTFU 预约。 对于第二阶段，与维持条件的人相比，接受加强条件的人以及 与 LTI 相比，收到 HTI 的人更有可能参加 T4 的预约。 T3 和自我管理指数是次要结果，我们还将评估干预的调节因素。 将评估结果、干预参与度、可接受性、可行性和成本。 与利益相关者（AYA、家长/支持者、 该试验响应 NOT-CA-22-029 和 PAR-21-035，以促进最佳效果。 参与 AYA 幸存者的 LTFU 和自我管理，改善结果并减少差异。