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: 10461176
• 负责人: Abby R Rosenberg
• 金额: $ 63.96万
• 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 2023-01-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10461176
• 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; psychosocial wellbeing; 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.

项目概要 青少年和年轻人 (AYAs) 中的癌症特别困难，因为与年龄相关 身份、人际关系和职业的发展挑战可能会增加癌症的负担。 与其他年龄组相比，患有晚期癌症的 AYA 的心理社会结果也较差。 许多人错过了向患者表达希望、担忧和临终偏好的机会 改善这些体验的一个潜在障碍可能是 AYA 很少。 我们有机会开发应对逆境所需的个人资源并表达他们的需求。 之前描述过针对 AYA 的“促进压力管理恢复力”(PRISM) 干预 这种手动的、简短的干预在 4 分钟内进行，是一对一的治疗，然后进行。 通过家庭会议，它的目标是压力管理和正念、目标设定、积极重构的技能， 所有这些技能都与改善其他人群的患者福祉有关， 最近在新诊断出癌症的 AYA 中进行的一项试点随机对照试验的结果表明 PRISM 与提高复原力、减少心理困扰和提高健康水平有关。 该应用程序建议以我们之前的经验为基础，并填写三个关键的内容。 知识差距：(1) PRISM 对晚期（相对于早期）癌症的 AYA 的影响 (2) AYA-PRISM 参与与家长结果之间的关联；以及 (3) PRISM 之间的关联 该资助机会旨在测试 AYA 特定的技能和患者参与。 旨在积极影响 HRQOL 的姑息治疗干预措施因此，我们提出了多地点随机治疗。 在 N=144 AYA（n=72 PRISM，n=72 常规护理；年龄 12-21 岁）中进行的对照试验以及主要试验 入组后 3 个月患者报告的 HRQOL 结果将包括患者。 和家长报告的焦虑和抑郁，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 我们勇敢地说，接受 PRISM 的 AYA 及其父母的报告会更高。 与接受常规护理的患者相比，HRQOL、焦虑/抑郁程度较低，激活程度较高。 该应用程序提供了扩展有关严格方法论的知识体系的机会 以及针对患有晚期癌症和癌症的 AYA 的基于证据的姑息治疗干预措施和护理标准 最终，这项研究有可能减轻这些弱势群体的癌症负担。 人口。