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

项目摘要 造血干细胞移植治疗恶性血液病的经验 青少年和年轻人（AYAs）特别困难，因为与年龄有关的 身份、关系和职业的发展挑战可能会增加 癌与其他年龄组相比，AYAs的心理社会结果较差，包括 焦虑和抑郁增加，口服免疫抑制剂依从性较差 药物治疗这些结果可能反过来使AYA易患疾病相关的发病率， 死亡率，如移植物抗宿主病（GVHD）和/或癌症复发。的势垒 改善这些经验可能是AYAs很少有机会发展 应对逆境所需的个人资源我们以前开发了“促进 压力管理中的弹性”（PRISM）干预患有严重疾病的AYA。这 在4个30-60分钟的一对一会议中进行手动简短干预，然后 家庭会议它的目标是压力管理和正念，目标设定，积极 重构和创造意义所有这些技能都与改善病人状况有关- 在其他人群中，以及最近关闭的试点随机 在新诊断癌症的AYA中进行的对照试验表明，PRISM与 改善与健康相关的生活质量。该应用程序建议建立在我们先前的 体验并填补关于PRISM在AYA接收中的影响的关键知识空白 HCT。因此，我们建议在N=70名AYA（n=35）中进行多中心随机对照试验 PRISM和n=35例常规治疗;年龄12-24岁），主要试验结局为患者- 有焦虑和抑郁的症状次要结局将包括患者 坚持口服GVHD预防和干预的成本效益， 人口我们假设，接受PRISM的AYA将报告较少的混合情感 症状和表现更好的坚持。我们还预计干预的成本- 有效总之，这一应用提供了一个机会，以扩大知识体系 关于方法上严格和基于证据的心理社会干预措施， 治疗患有血液系统恶性肿瘤的AYA的标准。最终，这项研究 降低这些弱势群体癌症负担的潜力。

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.