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.

项目总结/摘要 超过80%被诊断患有癌症的儿童成为长期幸存者;然而，70%的儿童发展为慢性或慢性疾病。 治疗的晚期效应会危及生命，这些效应往往出现在青年期。准则 建议每年进行一次长期随访护理（LTFU），以管理和监测晚期效应、复发或新发 癌症。然而，随着晚期效应的风险在年轻成年期增加，幸存者过渡到成年期， 护理，护理参与度直线下降。脱离LTFU使青少年和年轻成人幸存者 (AYA)易受延误或管理不善的诊断，并涉及知识和自我， 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。 人口为了解决这一关键的干预需求，我们提出了REACH（重新参与AYA幸存者） 癌症相关医疗保健）-一项创新的序贯多分配随机试验（SMART）， 两阶段设计。我们将利用我们的研究过渡到成人护理，生存护理计划，和数字 卫生干预措施。第1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，相比之下， 书面信息（WI）。接下来，在第2阶段，AYA将根据对第1阶段的反应性重新随机化 (i.e.,无论他们是否预约）进入16周的干预。响应者将被重新- 随机分配接受持续干预（维持）或加强治疗，而无应答者 只会得到更好的治疗升级可能包括扩大LTI（更多短信）或高 触摸干预（HTI）。HTI包括文本信息和数字资源，包括个性化的 幸存者护理计划（SCP），在一个移动友好的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，社会 工作人员和/或护士支持将可用于帮助克服障碍（例如，访问护理）。干预 第二阶段的选项旨在加强自我管理，而不仅仅是参加LTFU， 保持长期参与。在第1阶段（T2）、第2阶段（T3）和9个月后测量结局 （T4）。我们预计，那些从LTI与WI开始的人将更有可能在T4之前参加LTFU预约。 对于第二阶段，与维持治疗的患者相比， 与LTI相比，接受HTI的人更有可能在T4之前参加预约。出席预约 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、可接受性、可行性和成本。定性访谈将评估 与利益相关者（AYA，家长/支持者， 供应商、管理员）。本试验响应NOT-CA-22-029和PAR-21-035，以促进最佳 参与长期家庭护理和AYA幸存者的自我管理，改善结果并减少差异。