Randomized Waitlist-Control Trial of a Web-Based Stress-Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors: Protocol for the Bounce Back Study.

Randomized Waitlist-Control Trial of a Web-Based Stress-Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors: Protocol for the Bounce Back Study.
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DOI:
10.2196/34033
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发表时间:
2022-01-26
影响因子:
1.7
通讯作者:
Perez GK
Perez GK
中科院分区:
其他
文献类型:
--
作者:
Mizrach H;Goshe B;Park ER;Recklitis C;Greer JA;Chang Y;Frederick N;Abrams A;Tower MD;Walsh EA;Huang M;Kenney L;Homans A;Miller K;Denninger J;Usmani GN;Peppercorn J;Perez GK

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青春期和青壮年(Aya)癌症幸存者的情绪健康在癌症治疗期间和之后都受到损害。缺乏有针对性的计划,以支持AYA在完成治疗后的几年内应对压力的能力。心身计划可能会改善压力的负面心理和情绪影响,并帮助AYAS应对早期生存的心理社会挑战。我们的随机等待名单对照试验旨在评估虚拟团体计划(反弹)的可行性、可接受性和初步疗效,以促进治疗后AYA的压力管理和弹性。反弹是一项由训练有素的心理健康临床医生通过视频会议提供的压力管理和弹性计划。会议改编自循证心身计划(压力管理和弹性训练-放松反应弹性计划[SMART-3RP]),以放松反应启发、正念、认知行为疗法和积极心理学为基础。72名AYA(被诊断为癌症,年龄在14岁到29岁之间,并在最近5年内完成癌症治疗)被随机分配到反弹计划或等待名单对照组,并在基线、基线后3个月和基线后6个月完成评估。这项研究的主要目的是确定反弹计划的可行性和可接受性。描述性统计,包括方法、频率和范围,辅以定性的离职访谈反馈,将被用来描述样本的特征,并总结可行性和可接受性。探索性的目的是评估该计划在压力应对和心理社会结果测量(即焦虑、抑郁)方面的初步效果。这项研究于2017年7月由美国国家癌症研究所资助。研究程序于2018年10月由达纳-法伯哈佛癌症中心机构审查委员会批准(18-428号议定书)。该随机试验于2019年7月至2021年3月进行。定量数据收集已完成,定性离职面谈数据收集正在进行中。研究结果预计将在同行评议的期刊上发表,并在未来几年的地方、国家或国际会议上公布。几乎没有基于证据的计划来解决Aya癌症幸存者面临的关键过渡问题。未来的分析将帮助我们确定反弹计划的可行性和可接受性,以及它对Aya压力应对和心理健康的影响。ClinicalTrials.gov NCT03768336;https://clinicaltrials.gov/ct2/show/NCT03768336 dr1-10.2196/336
The emotional health of adolescent and young adult (AYA) cancer survivors is compromised both during and after cancer treatment. Targeted programs designed to support AYAs’ ability to cope with stress in the years following treatment completion are lacking. Mind-body programs may ameliorate the negative psychological and emotional effects of stress and assist AYAs with managing the psychosocial challenges of early survivorship. Our randomized waitlist-control trial aims to assess the feasibility, acceptability, and preliminary efficacy of a virtual group program (Bounce Back) to promote stress management and resiliency among posttreatment AYAs. Bounce Back is a stress management and resiliency program delivered via videoconference by a trained mental health clinician. Sessions were adapted from an evidence-based mind-body program (Stress Management and Resiliency Training - Relaxation Response Resiliency Program [SMART-3RP]) grounded in relaxation response elicitation, mindfulness, cognitive behavioral therapy, and positive psychology. Seventy-two AYAs (diagnosed with cancer between ages 14 years and 29 years and had completed cancer treatment within the last 5 years) were randomly assigned to the Bounce Back program or waitlist-control group and completed assessments at baseline, 3 months postbaseline, and 6 months postbaseline. The primary aim of the study is to determine the feasibility and acceptability of the Bounce Back program. Descriptive statistics, including means, frequencies, and ranges supplemented by qualitative exit interview feedback will be used to characterize the sample and to summarize feasibility and acceptability. The exploratory aims are to evaluate the preliminary effects of the program on stress coping and psychosocial outcome measures (ie, anxiety, depression) collected across the 3 time points. This study was funded by the National Cancer Institute in July 2017. Study procedures were approved by the Dana-Farber Harvard Cancer Center Institutional Review Board in October 2018 (Protocol 18-428). The randomized trial was conducted from July 2019 to March 2021. Quantitative data collection is complete, and qualitative exit interview data collection is ongoing. Results are expected to be published in peer-reviewed journals and presented at local, national, or international meetings in the coming years. Few evidence-based programs exist that tackle the key transitional issues faced by AYA cancer survivors. Future analyses will help us determine the feasibility and acceptability of the Bounce Back program and its impact on AYA stress coping and psychological well-being. ClinicalTrials.gov NCT03768336; https://clinicaltrials.gov/ct2/show/NCT03768336 DERR1-10.2196/34033
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