Oh Justin, Skinner Lawrie, Gutkin Paulina M, Jiang Alice, Donaldson Sarah S, Loo Billy W, Wang Yi Peng, Ewongwo Agnes, Bredfeldt Jeremy S, Breneman John C, Constine Louis S, Faught Austin M, Haas-Kogan Daphne, Holmes Jordan A, Krasin Matthew, Larkin Charlene, Marcus Karen J, Maxim Peter G, McClelland Shearwood, Murphy Blair, Palmer Joshua D, Perkins Stephanie M, Shen Colette J, Terezakis Stephanie, Bush Karl, Hiniker Susan M
Department of Radiation Oncology, Stanford University School of Medicine, Stanford, California.
Department of Radiation Oncology, BC Cancer - Vancouver, Vancouver, BC, Canada.
Adv Radiat Oncol. 2024 Aug 10;9(10):101589. doi: 10.1016/j.adro.2024.101589. eCollection 2024 Oct.
The Audiovisual-Assisted Therapeutic Ambience in Radiotherapy (AVATAR) trial was a prospective multicenter study (NCT03991156) examining the combination of video immersion with radiation therapy and was successfully conducted through the collaboration of pediatric radiation oncology teams at 10 institutions independent of any pre-existing consortium. We sought to analyze and report the methodology of trial conception and development, process map, and cost.
The study enrolled patients aged 3 to 10 years preparing to undergo radiation therapy, integrated the combination of AVATAR-based video immersion with radiation therapy at each institution, and offered AVATAR use as an alternative to anesthesia, with rates of anesthesia use and outcomes of serial standardized anxiety and quality-of-life assessments assessed among the 81 children enrolled. A process map was created based on the trial timeline with the following components: study development time (time from conception of the trial to the accrual of the first patient, including design phase, agreement and approval phase, and site preparation phase), and accrual duration time (time from the first to last accrual). Costs and institutional success rates were calculated.
Time from inception of study to last accrual was 3.6 years (1313 days). The study development time was 417 days (31.7%), and accrual duration time was 896 days (68.3%), with the final 50% of accrual occurring in <6 months. Equipment cost was approximately $550 per institution and was covered by funding from the lead study institution. All 10 centers were successful with AVATAR implementation, defined as ≥50% of patients able to avoid anesthesia with the use of AVATAR, including centers with both photon and proton therapy.
This report elaborates on the methodology and timeline of trial conception and development using data from a previously published supportive care study combining video immersion with radiation therapy among 10 cooperating pediatric oncology institutions. It highlights the potential for multicenter collaborations on prospective trials integrating supportive care therapies with radiation therapy.
放疗视听辅助治疗环境（AVATAR）试验是一项前瞻性多中心研究（NCT03991156），旨在研究视频沉浸式体验与放射治疗相结合的效果，该试验由10家机构的儿科放射肿瘤学团队合作成功开展，这些机构独立于任何现有的联盟。我们试图分析并报告试验构思与开展的方法、流程图及成本。
该研究纳入了准备接受放射治疗的3至10岁患者，在每个机构将基于AVATAR的视频沉浸式体验与放射治疗相结合，并提供AVATAR作为麻醉替代方案，对纳入的81名儿童的麻醉使用率以及系列标准化焦虑和生活质量评估结果进行了评估。根据试验时间表创建了一个流程图，包括以下组成部分：研究开展时间（从试验构思到首例患者入组的时间，包括设计阶段、协议与批准阶段以及场地准备阶段）和入组持续时间（从首例到末例入组的时间）。计算了成本和机构成功率。
从研究开始到末例入组的时间为3.6年（1313天）。研究开展时间为417天（31.7%），入组持续时间为896天（68.3%），最后50%的入组在不到6个月内完成。设备成本约为每个机构550美元，由牵头研究机构的资金支付。所有10个中心在AVATAR实施方面均取得成功，定义为≥50%的患者使用AVATAR能够避免麻醉，包括使用光子和质子治疗的中心。
本报告利用先前发表的一项支持性护理研究的数据，阐述了在10家合作的儿科肿瘤机构中，将视频沉浸式体验与放射治疗相结合的试验构思与开展的方法和时间表。它突出了在前瞻性试验中开展多中心合作，将支持性护理疗法与放射治疗相结合的潜力。
