The Promoting Resilience in Stress Management (PRISM) Intervention: a multi-site randomized controlled trial for Adolescents and Young Adults receiving Hematopoietic Cell Transplantation

项目总结 恶性血液病的造血细胞移植治疗体会 青少年和青年(AYA)特别困难，因为与年龄有关 身份、关系和职业方面的发展挑战可能会增加 癌症。与其他年龄组相比，AYA的心理社会结果更差，包括 焦虑和抑郁增加，口服免疫抑制药物依从性较差 药物。这些结果可能反过来使AYA容易患上与疾病相关的发病率和 移植物抗宿主病(GVHD)和/或癌症复发等死亡率。潜在的障碍 改善这些体验可能是因为AYA几乎没有机会发展 应对逆境所需的个人资源。我们之前已经开发了“推广” 压力管理中的弹性“(PRISM)对患有严重疾病的AYA进行干预。这 在4个30-60分钟的一对一会议中提供机械化的简短干预，然后 一次家庭会议。它的目标是压力管理和正念、设定目标、积极进取的技能 重构和意义创造。所有这些技能都与改善患者的健康状况有关- 在其他人群中，以及最近关闭的随机试验的初步发现 对患有新诊断癌症的AYA进行的对照试验表明，PRISM与 提高与健康相关的生活质量。此应用程序建议在以前的基础上构建 体验并填补关于PRISM在AYA中影响的关键知识空白 HCT。因此，我们提出了一项在N=70个AYA(n=35)中进行的多点随机对照试验 棱镜和n=35例常规护理；年龄12-24岁)，患者的主要试验结果- 报告了焦虑和抑郁的症状。次要结果将包括患者 口服GVHD预防的依从性和干预措施的成本-效果 人口。我们假设，接受PRISM的AYA报告的混合情感会更少 症状，并表现出更好的依从性。我们还预计干预将付出代价- 有效。总之，这个应用程序提供了一个扩展知识体系的机会 关于方法严谨和循证的心理社会干预措施 恶性血液病患者的护理标准。归根结底，这项研究具有 有可能减轻这些脆弱人群中的癌症负担。

PROJECT SUMMARY The experience of hematopoietic cell transplantation (HCT) for hematologic malignancy among Adolescents and Young Adults (AYAs) is particularly difficult because age-related developmental challenges of identity, relationships, and vocation may add to the burden of cancer. Compared to other age-groups, AYAs have poorer psychosocial outcomes including increased anxiety and depression and poorer adherence to oral immunosuppressive medications. These outcomes may, in turn, predispose AYAs to disease-related morbidity and mortality such as graft-versus-host disease (GVHD) and/or cancer-relapse. A potential barrier to improving these experiences may be that AYAs have few opportunities to develop the personal resources needed to handle adversity. We have previously developed the “Promoting Resilience in Stress Management” (PRISM) intervention for AYAs with serious illness. This manualized, brief intervention is delivered in 4, 30-60 minute, one-on-one sessions, followed by a family meeting. It targets skills in stress-management and mindfulness, goal-setting, positive reframing, and meaning-making. All of these skills are associated with improved patient well- being in other populations, and preliminary findings from a recently closed pilot randomized controlled trial among AYAs with newly diagnosed cancer suggest PRISM is associated with improved health-related quality of life. This application proposes to build on our prior experience and fill a critical knowledge gap regarding PRISM’s impact among AYAs receiving HCT. Thus, we propose a multi-site randomized controlled trial among N=70 AYAs (n=35 PRISM and n=35 usual care; ages 12-24 years), with the primary trial outcome of patient- reported symptoms of anxiety and depression. Secondary outcomes will include patient adherence to oral GVHD prophylaxis and the cost-effectiveness of the intervention in this population. We hypothesize that AYAs who receive PRISM will report fewer mixed affective symptoms and demonstrate better adherence. We also anticipate the intervention will be cost- effective. In sum, this application offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence-based psychosocial interventions and standards of care for AYAs with hematologic malignancies. Ultimately, this research has the potential to reduce the burden of cancer in these vulnerable populations.