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

促进压力管理复原力 (PRISM) 干预：一项针对接受造​​血细胞移植的青少年和年轻人的多中心随机对照试验

• 批准号: 10372988
• 负责人: Abby R Rosenberg
• 金额: $ 52.42万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10372988
• 关键词: Adherence; Adolescent and Young Adult; Affective; Affective Symptoms; Age; Analgesics; Anxiety; Cancer Burden; Cancer Relapse; Caring; Clinical; Clinical Trials; Cost Analysis; Cost utility; Development; Disease; Distress; Economics; Effectiveness of Interventions; Enrollment; Family; Future; Goals; Hematologic Neoplasms; Hospitals; Impairment; Intervention; Knowledge; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Mental Depression; Mental Health; Methodology; Monitor; Morbidity - disease rate; Newly Diagnosed; Oral; Outcome; Outcome Measure; Patient Outcomes Assessments; Patients; Personal Satisfaction; Persons; Pharmaceutical Preparations; Population; Positioning Attribute; Prophylactic treatment; Psychology; Psychosocial Assessment and Care; Quality of life; Quality-Adjusted Life Years; Randomized Controlled Trials; Recommendation; Recurrent Malignant Neoplasm; Reporting; Research; Resources; Risk; Self Care; Site; Stress; Sum; Symptoms; System; Time; Training; Training Programs; Vocation; Vulnerable Populations; age group; age related; anxiety symptoms; arm; base; brief intervention; burden of illness; cancer diagnosis; chronic pain; clinically relevant; compliance behavior; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; depressive symptoms; economic evaluation; evidence base; experience; graft vs host disease; health care service utilization; health related quality of life; hematopoietic cell transplantation; high risk; improved; improved outcome; innovation; medication compliance; meetings; microcosting; mindfulness; mortality; novel; person centered; programs; prospective; psychological distress; psychosocial; reduce symptoms; resilience; secondary analysis; secondary outcome; skills; stress management; survivorship; therapy design; tool; treatment as usual; trial comparing; willingness to pay

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.

项目摘要 造血细胞移植（HCT）的血液系统恶性肿瘤的经验 青少年和年轻人（AYA）特别困难，因为与年龄有关 身份，关系和投票的发展挑战可能会增加 癌症。与其他年龄段相比，AYA的社会心理结局较差 焦虑和抑郁症增加，对口服免疫抑制的依从性较差 药物。这些结果反过 死亡率，例如移植物抗宿主病（GVHD）和/或癌症。潜在的障碍 为了改善这些经验，可能是Ayas几乎没有机会开发 处理广告所需的个人资源。我们以前已经开发了“促进 压力管理中的韧性”（PRISM）干预患有严重疾病的AYA。 在4、30-60分钟内进行手动简短干预，一对一会议，其次是 家庭会议。它针对压力管理和正念，目标设定，积极的技能 重新构架和意义。所有这些技能都与改善的患者相关 在其他人群中，以及来自最近关闭的飞行员随机的初步发现 AYA中有新诊断的癌症的对照试验表明，Prism与 改善与健康相关的生活质量。本申请提案以我们的先验为基础 体验并填补有关棱镜在AYA接收的影响的关键知识差距 HCT。这，我们提出了n = 70 ayas之间的多站点随机对照试验（n = 35 棱镜和n = 35通常的护理；年龄12-24岁），患者的主要试验结果 报道了动画和抑郁的症状。次要结果将包括病人 遵守口服GVHD预防和干预的成本效益 人口。我们假设接受Prism的AYA将报告的混合情感更少 症状并表现出更好的依从性。我们还预计干预将是成本 - 有效的。总而言之，该应用程序提供了扩展知识体的机会 关注的方法论严格且基于证据的社会心理干预措施以及 具有血液系统恶性肿瘤的AYA的护理标准。最终，这项研究具有 在这些脆弱人群中减少癌症的爆炸的潜力。