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 青少年血液学恶性肿瘤的造血细胞移植（HCT）的经验 和年轻人（AYA）特别困难，因为与年龄相关的身份相关的发展挑战， 人际关系和投票可能会增加癌症的燃烧。与其他年龄段相比 较差的社会心理结局，包括焦虑和抑郁症的增加以及对口腔的依从性较差 免疫抑制药物可能使AYA易于疾病相关的发病率和/或 癌症 - 释放。改善这些经验的潜在障碍可能是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。 干预措施在4、30-60分钟内进行一对一会议，然后是父母/照顾者/配偶/ 其他重要的会议。它针对压力管理和正念，目标设定的技能， 积极的重塑和意义创造。 AYA中2期随机对照试验的发现 通过新诊断的癌症，棱镜与改善心理困扰和 与健康相关的生活质量提高。这项研究将以我们先前的经验为基础，并填补批判知识 关于Prism在接受HCT的AYA的影响的差距。那，我们将进行多站点随机 n = 70 ayas之间的对照试验（n = 35 prism和n = 35个常规护理； 12-24岁），主要试验 患者报告的焦虑和抑郁症状的结果。我们假设接受 棱镜将报告较少的混合情感症状，表现出更好的依从性并显示出改善 生物医学结果，而父母报告的生活质量和心理困扰改善了。这项研究 提供了扩大有关方法论严格和证据的知识的机会 - 基于血液学恶性肿瘤的AYA的基于心理心理干预措施和护理标准，并具有 在这些脆弱人群中减少癌症的爆炸的潜力。 在此拟议的多样性补充中，我将为评估Prism在降低症状的效率上做出贡献 在HCT前六个月内，焦虑和抑郁，通过协助与招聘有关的程序， 数据收集和分析。