The Promoting Resilience in Stress Management (PRISM) Intervention: a multi-site randomized controlled trial for Adolescents and Young Adults with advanced cancer

促进压力管理复原力 (PRISM) 干预：一项针对患有晚期癌症的青少年和年轻人的多中心随机对照试验

• 批准号: 9750647
• 负责人: Abby R Rosenberg
• 金额: $ 59.8万
• 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: 2018-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9750647
• 关键词: Address; Adolescent; Adolescent and Young Adult; Advance Care Planning; Advanced Malignant Neoplasm; Advocacy; Age; Anxiety; Cancer Burden; Caregivers; Caring; Childhood; Clinical; Communication; Data; Development; Diagnosis; Distress; Enrollment; Equipment and supply inventories; Evidence based intervention; Family; Frequencies; Fright; Funding Opportunities; Goals; Guidelines; Health Promotion; Hospitals; Intervention; Knowledge; Malignant Neoplasms; Measures; Medical Records; Mental Depression; Methodology; Newly Diagnosed; Outcome; Palliative Care; Parents; Participant; Patient Outcomes Assessments; Patients; Perception; Personal Satisfaction; Persons; Population; Progressive Disease; Psychiatric Social Work; Quality of life; Randomized Controlled Trials; Recurrent Malignant Neoplasm; Recurrent disease; Refractory Disease; Reporting; Research; Resources; SF-36; Series; Site; Standardization; Surveys; Teenagers; Testing; Time; Training Programs; Translating; Vocation; Vulnerable Populations; age group; age related; anxiety states; arm; base; brief intervention; cancer diagnosis; care systems; clinical decision-making; end of life; evidence base; experience; family management; health related quality of life; high risk; hospice environment; improved; improved outcome; meetings; mindfulness; novel; novel strategies; oncology; palliative; patient engagement; person centered; preference; primary endpoint; programs; psychological distress; psychosocial; resilience; secondary outcome; skills; stress management; therapy design; trait; treatment as usual; trial comparing; willingness; young adult

PROJECT SUMMARY Cancer 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. Among AYAs with advanced cancer, too many miss opportunities to express their hopes, worries and end-of-life preferences, translating to both patient and parent distress. A potential barrier to improving these experiences may be that AYAs have few opportunities to develop the personal resources needed to handle adversity and articulate their needs. We have previously described the “Promoting Resilience in Stress Management” (PRISM) intervention for AYAs with cancer. 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 findings from a recent pilot randomized controlled trial among AYAs with newly diagnosed cancer suggest PRISM is associated with improved perceptions of resilience, lower psychological distress, and higher health- related quality of life (HRQOL). This application proposes to build on our prior experience and fill three critical knowledge gaps: (1) PRISM’s impact among AYAs with advanced (as opposed to early stage) cancer; (2) Associations between AYA-PRISM participation and parent outcomes; and, (3) Associations between PRISM skills and patient engagement in clinical decision-making. This funding opportunity seeks to test AYA-specific palliative care interventions designed to positively impact HRQOL. Thus, we propose a multi-site randomized controlled trial among N=144 AYAs (n=72 PRISM, n=72 Usual Care; ages 12-21) with the primary trial outcome of patient-reported HRQOL 3 months following enrollment. Secondary outcomes will include patient- and parent-reported anxiety and depression, and family “palliative care activation” (advocacy on behalf of AYA’s hopes and worries, engagement in goals-of-care conversations, and utilization of formal palliative care and psychosocial services). We hypothesize that AYAs who receive PRISM and their parents will report higher HRQOL, lower anxiety/depression, and higher activation when compared to those who receive usual care. This application offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence-based palliative care interventions and standards of care for AYAs with advanced cancer and their families. Ultimately, this research has the potential to reduce the burden of cancer in these vulnerable populations.

项目总结 青少年和青年癌症(AYA)特别困难，因为与年龄有关 身份、人际关系和职业方面的发展挑战可能会增加癌症的负担。相比较 对于其他年龄段的人来说，AYA的心理社会结果更差。在癌症晚期的AYA中也是如此 许多人错过了表达他们的希望、担忧和临终偏好的机会，转化为 和父母的痛苦。改善这些体验的一个潜在障碍可能是AYA几乎没有 有机会开发应对逆境所需的个人资源，并清楚地表达自己的需求。我们 之前曾描述过针对AYA的“促进压力管理中的韧性”(PRISM)干预 得了癌症。这种手动的简短干预在4个30-60分钟的一对一会议中进行，随后 通过一次家庭会议。它的目标是压力管理和正念、目标设定、积极重组、 和意义的创造。所有这些技能都与其他人群患者幸福感的改善有关， 最近在新诊断为癌症的AYA中进行的一项试点随机对照试验的结果表明 棱镜与更好的韧性、更低的心理痛苦和更高的健康水平有关- 相关生活质量(HRQOL)。此应用程序建议以我们以前的经验为基础，填补三个关键的 知识差距：(1)PRISM在晚期(而不是早期)癌症患者中的影响；(2) Aya-PRISM参与与父母结果之间的关联；以及，(3)PRISM之间的关联 临床决策中的技能和患者参与度。这一融资机会寻求测试特定于Aya的 旨在积极影响HRQOL的姑息治疗干预。因此，我们提出了一种多站点随机 在N=144名AYA(n=72名PRISM，n=72名普通护理人员；年龄12-21岁)中进行的对照试验和初步试验 登记后3个月患者报告的HRQOL结果。次要结果将包括患者- 和父母报告的焦虑和抑郁，以及家庭“姑息关怀激活”(代表 阿雅的希望和担忧，参与护理目标对话，以及正式姑息护理的利用 和心理社会服务)。我们假设，接受PRISM的AYA及其父母的报告会更高 与那些接受常规护理的人相比，他们的生活质量更高，焦虑/抑郁程度更低，活跃度更高。 这个应用程序提供了一个机会来扩展关于方法严谨的知识体系 和基于证据的姑息治疗干预措施和对患有晚期癌症和 他们的家人。最终，这项研究有可能减轻这些脆弱人群的癌症负担 人口。