The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol.
The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol.
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DOI：
10.1186/s12904-022-00966-9
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发表时间：
2022-05-19
影响因子：
3.1
通讯作者：
Rosenberg, Abby R.
中科院分区：
文献类型：
--
作者：
Fladeboe, Kaitlyn M.;Scott, Samantha;Comiskey, Liam;Zhou, Chuan;Yi-Frazier, Joyce P.;Rosenberg, Abby R.
关键词：
心理困扰在接受造血细胞移植(HCT)的青少年和青壮年(AYA)中普遍存在。压力管理中的促进复原力(PRISM)干预是一项复原力训练计划，已被证明可以缓解新诊断或晚期癌症化疗的AYA的痛苦并提高生活质量。这篇文章描述了一项正在进行的随机对照试验(RCT)的方案，该试验检验了PRISM在接受HCT治疗癌症和/或血液疾病的AYA中的疗效。这项多点、平行、随机对照试验的目的是评估PRISM与心理社会日常护理(UC)在接受HCT的AYA中的效果。我们的主要假设是，与接受UC的人相比，接受PRISM的AYA在登记后6个月报告的抑郁和焦虑程度较低。PRISM计划包括四个脚本化的辅导课程，目标是压力管理、目标设定、认知重建和意义创造方面的技能，然后是一个促成的家庭会议。会议以一对一、1-2 周为间隔、面对面或通过视频会议进行。我们的目标是从4个美国儿科Aya肿瘤学中心招募90名AYA。符合条件的AYA年龄为12-24 岁；因恶性肿瘤或与癌症易感性有关的骨髓衰竭综合征接受Hct；<； 从Hct日期起4 周；能够说英语和阅读英语或西班牙语；以及能够认知完成疗程。登记的AYA在每个站点内以1：1的随机比例接受PRISM+UC或仅接受UC。两个研究组的Ayas在基线、3个月和6个月时完成患者报告的结果调查。年龄有效的工具评估抑郁和焦虑，总体和癌症相关的健康相关生活质量，症状负担，韧性和希望。协变量调整的回归模型将比较PRISM组和UC组6个月时Aya报告的抑郁和焦虑。次要和探索性目标包括评估PRISM的成本效益及其对以下方面的影响：(I)父母和照顾者的生活质量和精神健康；(Ii)口服移植物抗宿主病(GVHD)预防的药物依从性；(Iii)移植植入和移植物抗宿主病等生物结果；以及(Iv)应激的生物标记物，如心率变异性和保守的逆境转录反应(CTRA)基因表达谱。如果成功，这项研究有可能解决接受HCT的AYA在全患者护理方面的一个关键缺口。ClinicalTrials.gov标识符NCT03640325,2018年8月21日。
Psychological distress is prevalent among adolescents and young adults (AYAs) receiving hematopoietic cell transplantation (HCT). The Promoting Resilience in Stress Management (PRISM) intervention is a resilience-coaching program that has been shown to mitigate distress and improve quality of life among AYAs receiving chemotherapy for newly diagnosed or advanced cancer. This article describes the protocol of an ongoing randomized-controlled trial (RCT) examining the efficacy of PRISM among AYAs receiving HCT for cancer and/or blood disorders. The goal of this multi-site, parallel, RCT is to evaluate the effect of PRISM compared to psychosocial usual care (UC) among AYAs receiving HCT. Our primary hypothesis is that AYAs who receive PRISM will report lower depression and anxiety 6-months following enrollment compared to those who receive UC. The PRISM program includes four scripted coaching sessions targeting skills in stress-management, goal setting, cognitive-restructuring, and meaning-making, followed by a facilitated family meeting. Sessions are delivered one on one, 1–2 weeks apart, in-person or via videoconference. We aim to recruit 90 AYAs from 4 US pediatric AYA oncology centers. Eligible AYAs are aged 12–24 years; receiving HCT for malignancy or a bone marrow failure syndrome associated with cancer predisposition; < 4 weeks from their HCT date; able to speak English and read in English or Spanish; and cognitively able to complete sessions. Enrolled AYAs are randomized 1:1 within each site to receive PRISM+UC or UC alone. AYAs on both study-arms complete patient-reported outcome surveys at baseline, 3- and 6-months. Age-valid instruments assess depression and anxiety, overall and cancer-specific health-related quality of life, symptom burden, resilience, and hope. Covariate-adjusted regression models will compare AYA-reported depression and anxiety at 6-months in the PRISM versus UC groups. Secondary and exploratory objectives include assessments of PRISM’s cost-effectiveness and its impact on (i) parent and caregiver quality of life and mental health, (ii) pharmaco-adherence to oral graft-versus-host disease (GVHD) prophylaxis, (iii) biologic outcomes such as transplant engraftment and graft-versus-host disease, and (iv) biomarkers of stress such as heart rate variability and the Conserved Transcriptional Response to Adversity (CTRA) gene expression profile. If successful, this study has the potential to address a critical gap in whole-patient care for AYAs receiving HCT. ClinicalTrials.gov Identifier NCT03640325, August 21, 2018.
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影响因子：
7.4
作者：
Connor, KM;Davidson, JRT
通讯作者：
Davidson, JRT
影响因子：
5.9
作者：
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影响因子：
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作者：
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影响因子：
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作者：
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DOI：
10.1111/j.2517-6161.1995.tb02031.x
发表时间：
1995-01-01
影响因子：
5.8
作者：
BENJAMINI, Y;HOCHBERG, Y
通讯作者：
HOCHBERG, Y