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: 10310773
• 负责人: Abby R Rosenberg
• 金额: $ 5.22万
• 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 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10310773
• 关键词: Adherence; Adolescent and Young Adult; Affective Symptoms; Age; Anxiety; Cancer Burden; Cancer Relapse; Caring; Data Collection; Development; Disease; Goals; Health behavior; Hematologic Neoplasms; Intervention; Knowledge; Mental Depression; Mental Health; Methodology; Morbidity - disease rate; Newly Diagnosed; Oral; Outcome; Parents; Patient Outcomes Assessments; Patients; Pharmaceutical Preparations; Phase; Procedures; Quality of life; Randomized Controlled Trials; Reporting; Resources; Risk; Site; Spouse Caregiver; Vocation; Vulnerable Populations; age group; age related; anxiety symptoms; brief intervention; cancer diagnosis; evidence base; experience; health related quality of life; hematopoietic cell transplantation; high risk population; improved; meetings; mindfulness; novel; psychological distress; psychosocial; randomized trial; recruit; reduce symptoms; resilience; skills; stress management; treatment as usual

PROJECT ABSTRACT 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 potentially predisposing AYAS to disease-related morbidity and 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 Parent/ Caregiver/ Spouse/ significant other inclusive meeting. It targets skills in stress-management and mindfulness, goal-setting, positive reframing, and meaning-making. Findings from a phase 2 randomized controlled trial among AYAs with newly diagnosed cancer demonstrate that PRISM is associated with decreased psychological distress and increased health-related quality of life. This study will build on our prior experience and fill a critical knowledge gap regarding PRISM’s impact among AYAs receiving HCT. Thus, we will conduct 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. We hypothesize that AYAs who receive PRISM will report fewer mixed affective symptoms, demonstrate better adherence, and show improved biomedical outcomes, while their parents report improved quality of life and psychological distress. This study 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 and has the potential to reduce the burden of cancer in these vulnerable populations. In this proposed diversity supplement, I will contribute to evaluating PRISM’s efficacy in reducing symptoms of anxiety and depression over the first 6-months post-HCT by assisting with procedure related to recruitment, data collection, and analysis.

项目摘要 造血细胞移植治疗青少年恶性血液病的体会 和年轻人（AYAs）特别困难，因为与年龄有关的身份发展挑战， 人际关系和职业可能会增加癌症的负担。与其他年龄组相比， 社会心理结局较差，包括焦虑和抑郁增加以及口服药物依从性较差 免疫抑制药物可能使AYAS易患疾病相关的发病率和/或 癌症复发改善这些体验的一个潜在障碍可能是AYA几乎没有机会 来开发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。这种手册化的，简短的 干预是在4个，30-60分钟，一对一的会议，其次是父母/照顾者/配偶/ 其他重要的包容性会议。它的目标是压力管理和正念，目标设定， 积极的重构和创造意义来自AYA中的II期随机对照试验的结果 新诊断的癌症患者的研究表明，PRISM与减少心理困扰有关， 提高健康相关的生活质量。这项研究将建立在我们以前的经验，并填补了关键的知识 关于PRISM在接受HCT的AYA中的影响的差距。因此，我们将进行多中心随机化 在N=70名AYA（n=35名PRISM和n=35名常规护理;年龄12-24岁）中进行的对照试验，以及主要试验 患者报告的焦虑和抑郁症状的结局。我们假设， PRISM将报告更少的混合情感症状，表现出更好的依从性，并显示出改善 他们的父母报告说，他们的生活质量和心理压力得到了改善。本研究 提供了一个机会，以扩大知识体系，有关方法的严格性和证据- 基于心理社会干预和标准的护理与血液恶性肿瘤的AYA，并已 降低这些弱势群体癌症负担的潜力。 在这个建议的多样性补充，我将有助于评估PRISM的有效性，在减少症状， HCT后前6个月内的焦虑和抑郁，通过协助与招募相关的程序， 数据收集和分析。