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: 9979827
• 负责人: Abby R Rosenberg
• 金额: $ 23.72万
• 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/9979827
• 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; 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（AYA）中的癌症特别困难，因为与年龄有关 身份，人际关系和投票的发展挑战可能会增加癌症的燃烧。比较的 对于其他年龄段，AYA的社会心理成果较差。在患有晚期癌症的AYA中 许多人错过了表达自己的希望，奇迹和寿命终止偏好的机会，转化为两位患者 和父母的困扰。改善这些经历的潜在障碍可能是Ayas很少 开发处理广告并阐明其需求所需的个人资源的机会。我们 以前已经描述了对AYAS的“促进压力管理中的弹性”（PRISM）干预 癌症。这项手动，简短的干预措施在4、30-60分钟内进行，一对一会议，然后进行 在家庭会议上。它针对压力管理和正念，目标设定，积极重新构架的技能， 和意义的创造。所有这些技能都与其他人群的患者福祉改善有关， 以及最近一次试点随机对照试验的发现，与新诊断为癌症的AYA中 棱镜与改善韧性的看法有关，心理困扰降低以及健康较高 - 相关生活质量（HRQOL）。本申请提案以我们以前的经验为基础，并填补三个关键 知识差距：（1）Prism在患有癌症（而不是早期）癌症的AYAS中的影响； （2） Aya-Prism参与与父母成果之间的关联； （3）棱镜之间的关联 技能和患者参与临床决策。这个资金机会旨在测试特定于AYA的资金 旨在积极影响HRQOL的姑息治疗干预措施。这，我们提出了一个随机的多站点 n = 144 AYAS中的对照试验（n = 72 prism，n = 72通常的护理； 12-21岁） 入学后3个月的患者报告HRQOL的结果。次要结果将包括患者 - 以及父母报告的焦虑和抑郁，家庭“姑息治疗激活”（代表倡导 Aya的希望和勇气，参与护理目标对话以及对正式姑息治疗的利用 和社会心理服务）。我们假设接受Prism及其父母的AYA会报告更高 与接受常规护理的人相比，HRQOL，较低的焦虑/抑郁症和更高的激活。 该应用程序提供了扩展有关方法严格的知识的机会 以及基于循证的姑息治疗干预措施和患有晚期癌症的AYA的护理标准 他们的家人。最终，这项研究有可能减少这些脆弱的癌症的癌症 人群。