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: 10241393
• 负责人: Abby R Rosenberg
• 金额: $ 62.52万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10241393
• 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; Oncology; 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; feasibility testing; health related quality of life; high risk; hospice environment; improved; improved outcome; meetings; mindfulness; novel; novel strategies; 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.

项目摘要 青少年和年轻人（AYAs）中的癌症特别困难，因为与年龄有关 身份，关系和职业的发展挑战可能会增加癌症的负担。相比 与其他年龄组相比，AYAs的心理社会结果较差。在患有晚期癌症的AYA中， 许多人错过了表达他们的希望、担忧和临终偏好的机会， 和父母的痛苦改善这些体验的一个潜在障碍可能是， 发展个人资源的机会，以处理逆境和阐明他们的需求。我们 我以前描述过针对AYA的“促进压力管理中的恢复力”（PRISM）干预 得了癌症这种手动的简短干预分为4个30-60分钟的一对一课程， 召开家庭会议它的目标是压力管理和正念，目标设定，积极重构， 和创造意义所有这些技能都与改善其他人群的患者福祉相关， 最近一项在新诊断癌症的AYA中进行的试点随机对照试验的结果表明 PRISM与改善的弹性感知、较低的心理困扰和较高的健康水平相关- 相关生活质量（HRQOL）。此应用程序建议建立在我们以前的经验，并填补三个关键 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参与和父母结局之间的关联;以及（3）PRISM之间的关联 技能和患者参与临床决策。该融资机会旨在测试AYA特定的 姑息治疗干预措施旨在对HRQOL产生积极影响。因此，我们提出了一个多站点随机 在N=144名AYA（n=72名PRISM，n=72名家庭护理;年龄12-21岁）中进行的对照试验与主要试验 入组后3个月患者报告的HRQOL结局。次要结局将包括患者- 和父母报告的焦虑和抑郁，以及家庭“姑息治疗激活”（代表 AYA的希望和担忧，参与护理目标对话，以及正式姑息治疗的利用 社会心理服务）。我们假设，接受PRISM的AYA及其父母的报告会更高 HRQOL，较低的焦虑/抑郁，和较高的激活相比，那些接受常规护理。 这个应用程序提供了一个机会，以扩大知识体系，关于方法上严格 和循证姑息治疗干预措施和标准的护理AYA与先进的癌症， 家人最终，这项研究有可能减少这些脆弱人群的癌症负担。 人口。