Protocol for the promoting resilience in stress management (PRISM) intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer.
Protocol for the promoting resilience in stress management (PRISM) intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer.
复制标题
DOI：
10.1186/s12904-023-01179-4
复制
发表时间：
2023-05-16
影响因子：
3.1
通讯作者：
Rosenberg, Abby R.
中科院分区：
文献类型：
--
作者：
O'Daffer, Alison;Comiskey, Liam;Scott, Samantha R.;Zhou, Chuan;Bradford, Miranda C.;Yi-Frazier, Joyce P.;Rosenberg, Abby R.
患有癌症的青少年和年轻人（AYA）的心理社会成果不佳，旨在满足其社会心理和沟通需求的循证干预措施是该项目的主要目的是测试促进AYAS与晚期癌症（Prism-Ac-Ac-ac）促进恢复恢复疗程的新适应性。
The PRISM-AC trial is a 2-arm, parallel, non-blinded, multisite, randomized controlled trial. 144 participants with advanced cancer will be enrolled and randomized to either usual, non-directive, supportive care without PRISM-AC (“control” arm) or with PRISM-AC (“experimental” arm). PRISM is a manualized, skills-based training program completed of four 30–60 min, one-on-one sessions targeting AYA-endorsed resilience资源（压力管理，目标设定，认知 - 重新制作）还包括准备好的家庭会议和设备齐全的智能手机应用程序。 4学术中心有资格，如果他们能够读取并阅读英语或西班牙语，并且可以在所有小组中参与其中，他们可以参加这项研究。 （HRQOL）和感兴趣的次要结果包括患者动画，抑郁症，韧性，希望和符号负担，父母/照顾者动画，抑郁症和与健康相关的生活质量以及家庭姑息治疗激活，我们将进行意图验证分析，以比较Prism-Ac-Ac-Ac-Ac-Ac-Ac-Ac-Ac-ac-Ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac-ac的模型。
这项研究将提供有关促进韧性并减少晚期癌症的痛苦的新型干预措施的方法严格的数据和证据。
Clinicaltrials.gov标识符NCT03668223，2018年9月12日。
Adolescents and young adults (AYAs) with cancer are at high risk of poor psychosocial outcomes, and evidence-based interventions designed to meet their psychosocial and communication needs are lacking. The main objective of this project is to test the efficacy of a new adaptation of the Promoting Resilience in Stress Management intervention for AYAs with Advanced Cancer (PRISM-AC). The PRISM-AC trial is a 2-arm, parallel, non-blinded, multisite, randomized controlled trial. 144 participants with advanced cancer will be enrolled and randomized to either usual, non-directive, supportive care without PRISM-AC (“control” arm) or with PRISM-AC (“experimental” arm). PRISM is a manualized, skills-based training program comprised of four 30–60 min, one-on-one sessions targeting AYA-endorsed resilience resources (stress-management, goal-setting, cognitive-reframing, and meaning-making). It also includes a facilitated family meeting and a fully equipped smartphone app. The current adaptation includes an embedded advance care planning module. English- or Spanish-speaking individuals 12–24 years old with advanced cancer (defined as progressive, recurrent, or refractory disease, or any diagnosis associated with < 50% survival) receiving care at 4 academic medical centers are eligible. Patients’ caregivers are also eligible to participate in this study if they are able to speak and read English or Spanish, and are cognitively and physically able to participate. Participants in all groups complete surveys querying patient-reported outcomes at the time of enrollment and 3-, 6-, 9-, and 12-months post-enrollment. The primary outcome of interest is patient-reported health-related quality of life (HRQOL) and secondary outcomes of interest include patient anxiety, depression, resilience, hope and symptom burden, parent/caregiver anxiety, depression and health-related quality of life, and family palliative care activation. We will conduct intention-to-treat analysis to compare the group means of primary and secondary outcomes between PRISM-AC arm and control arm with regression models. This study will provide methodologically rigorous data and evidence regarding a novel intervention to promote resilience and reduce distress among AYAs with advanced cancer. This research has the potential to offer a practical, skills-based curriculum designed to improve outcomes for this high-risk group. ClinicalTrials.gov Identifier NCT03668223, September 12, 2018.
登录
查看更多内容
影响因子：
3.2
作者：
Jacobs, Shana;Perez, Jennie;Lyon, Maureen E.
通讯作者：
Lyon, Maureen E.
影响因子：
7.4
作者：
Connor, KM;Davidson, JRT
通讯作者：
Davidson, JRT
影响因子：
11.5
作者：
Andersen, Barbara L.;Thornton, Lisa M.;Carson, William E., III
通讯作者：
Carson, William E., III
影响因子：
4.7
作者：
Collins, JJ;Devine, TD;Portenoy, RK
通讯作者：
Portenoy, RK
影响因子：
3.3
作者：
Löwe, B;Gräfe, K;Herzog, W
通讯作者：
Herzog, W