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.

项目概要 造血细胞移植（HCT）治疗血液恶性肿瘤的经验 青少年和年轻人 (AYAs) 特别困难，因为与年龄相关 身份、人际关系和职业的发展挑战可能会增加负担 与其他年龄组相比，AYA 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 反过来，这些结果可能使 AYA 易患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是一个潜在的障碍。 改善这些体验的原因可能是 AYA 很少有机会发展 应对逆境所需的个人资源我们之前制定了“促进”。 针对患有严重疾病的 AYA 的“压力管理弹性”(PRISM) 干预措施。 在 4、30-60 分钟的一对一会议中进行手动、简短的干预，然后 家庭会议的目标是压力管理和正念、目标设定、积极方面的技能。 所有这些技能都与改善患者健康有关。 在其他人群中，以及最近结束的随机试验的初步结果 对新诊断癌症的 AYA 进行的对照试验表明 PRISM 与 该应用程序旨在改善与健康相关的生活质量。 经验并填补有关 PRISM 对接收 AYA 的影响的关键知识空白 因此，我们建议在 N=70 个 AYA（n=35）中进行一项多中心随机对照试验。 PRISM 和 n=35 例常规护理；年龄 12-24 岁），主要试验结果为患者- 报告的焦虑和抑郁症状将包括患者。 口服 GVHD 预防的依从性以及干预措施的成本效益 我们追求接受 PRISM 的 AYA 报告的混合情感较少。 我们还预计干预措施将具有成本效益。 总之，该应用程序提供了扩展知识体系的机会。 关于方法论上严格和基于证据的心理社会干预措施 最终，本研究确定了患有血液系统恶性肿瘤的 AYA 的护理标准。 减少这些弱势群体癌症负担的潜力。