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.

中文翻譯：

壓力管理 (PRISM) 干預(yù)中促進(jìn)彈性的方案：一項(xiàng)針對患有晚期癌癥的青少年和年輕人的多中心隨機(jī)對照試驗(yàn)

患有癌癥的青少年和年輕成人 (AYAs) 面臨心理社會后果不佳的高風(fēng)險，并且缺乏旨在滿足他們心理社會和溝通需求的循證干預(yù)措施。該項(xiàng)目的主要目標(biāo)是測試針對患有晚期癌癥的 AYAs (PRISM-AC) 的壓力管理干預(yù)中促進(jìn)復(fù)原力的新改編的有效性。PRISM-AC 試驗(yàn)是一項(xiàng) 2 臂、平行、非盲、多中心、隨機(jī)對照試驗(yàn)。將招募 144 名患有晚期癌癥的參與者，并隨機(jī)分配到不使用 PRISM-AC（“控制”臂）或使用 PRISM-AC（“實(shí)驗(yàn)”臂）的常規(guī)、非指導(dǎo)性、支持性護(hù)理。PRISM 是一項(xiàng)基于技能的手動培訓(xùn)計(jì)劃，由四個 30-60 分鐘的一對一課程組成，針對 AYA 認(rèn)可的彈性資源（壓力管理、目標(biāo)設(shè)定、認(rèn)知重構(gòu)和意義建構(gòu)）。它還包括一個便利的家庭會議和一個設(shè)備齊全的智能手機(jī)應(yīng)用程序。當(dāng)前的改編包括一個嵌入式預(yù)先護(hù)理計(jì)劃模塊。在 4 個學(xué)術(shù)醫(yī)療中心接受治療的 12-24 歲的講英語或西班牙語的晚期癌癥患者（定義為進(jìn)行性、復(fù)發(fā)性或難治性疾病，或任何與生存率 < 50% 相關(guān)的診斷）符合條件。如果患者的護(hù)理人員能夠說和讀英語或西班牙語，并且在認(rèn)知和身體上能夠參與，他們也有資格參與這項(xiàng)研究。所有組的參與者都完成調(diào)查，詢問患者在入組時和入組后 3、6、9 和 12 個月時報告的結(jié)果。感興趣的主要結(jié)果是患者報告的與健康相關(guān)的生活質(zhì)量 (HRQOL)，感興趣的次要結(jié)果包括患者焦慮、抑郁、恢復(fù)力、希望和癥狀負(fù)擔(dān)、父母/看護(hù)者焦慮、抑郁和與健康相關(guān)的生活質(zhì)量，和家庭姑息治療激活。我們將進(jìn)行意向治療分析，以使用回歸模型比較 PRISM-AC 組和對照組之間主要和次要結(jié)果的組均值。這項(xiàng)研究將提供方法論上嚴(yán)格的數(shù)據(jù)和證據(jù)，說明一種新的干預(yù)措施，以促進(jìn)患有晚期癌癥的 AYA 的復(fù)原力和減少痛苦。這項(xiàng)研究有可能提供實(shí)用的、基于技能的課程，旨在改善這一高風(fēng)險群體的結(jié)果。ClinicalTrials.gov 標(biāo)識符 NCT03668223，2018 年 9 月 12 日。

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