Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial.
Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial.
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DOI：
10.1007/s11060-023-04271-0
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发表时间：
2023-03
影响因子：
3.9
通讯作者：
Armstrong, Terri S.
中科院分区：
文献类型：
--
作者：
King, Amanda L.;Roche, Kayla N.;Leeper, Heather E.;Vera, Elizabeth;Mendoza, Tito;Mentges, Kelly;Acquaye-Mallory, Alvina A.;Adegbesan, Kendra A.;Boris, Lisa;Burton, Eric;Choi, Anna;Grajkowska, Ewa;Kunst, Tricia;Levine, Jason;Lollo, Nicole;Miller, Hope;Panzer, Marissa;Penas-Prado, Marta;Pillai, Valentina;Polskin, Lily;Reyes, Jennifer;Sahebjam, Solmaz;Stockdill, Macy L.;Theeler, Brett J.;Wu, Jing;Gilbert, Mark R.;Armstrong, Terri S.
癌症患者在接受成像研究以监测疾病状态时会感到痛苦和焦虑，但这些症状并不总是得到适当的识别或良好的管理。这项II期临床试验的中期分析探讨了在临床评价时对原发性脑肿瘤（PBT）患者进行虚拟现实放松（VR）干预的可行性和可接受性。在2021年3月至2022年3月期间招募了讲英语的成年PBT患者，这些患者先前报告了痛苦和即将进行的神经成像。在神经成像前2周内进行简短的VR会话，并在干预前和干预后立即收集患者报告的结局（PRO）。鼓励在接下来的1个月内使用自我导向VR，并在第1周和第4周进行额外的PRO评估。可行性指标包括入组、合格性、损耗和器械相关不良反应，以及通过定性电话访谈测量的满意度。通过电子邮件联系了55例患者，40例（73%）回复，20例（50%）入组（9例下降，11例筛选失败）。65%的受试者年龄≤ 50岁，50%为男性，90%为白色/非西班牙裔，85%的KPS良好（≥ 90），大多数接受活性治疗。所有患者均完成VR干预、PRO问卷、每周检查和定性访谈。大多数（90%）报告了频繁使用VR和高满意度，仅记录了7起轻度AE（头痛、头晕、恶心、颈部疼痛）。这项中期分析支持一种新的VR干预措施的可行性和可接受性，以针对PBT患者的心理症状。试验入组将继续评估干预疗效。NCT 04301089于2020年3月9日注册。在线版本包含补充材料，可通过10.1007/s11060-023-04271-0获得。
Cancer patients experience distress and anxiety when undergoing imaging studies to monitor disease status, yet these symptoms are not always appropriately identified or well-managed. This interim analysis of a phase 2 clinical trial explored feasibility and acceptability of a virtual reality relaxation (VR) intervention for primary brain tumor (PBT) patients at the time of clinical evaluation. English speaking, adult PBT patients with previous reports of distress and upcoming neuroimaging were recruited between March of 2021 and March 2022. A brief VR session was done within 2 weeks prior to neuroimaging with patient-reported outcomes (PROs) collected before and immediately post-intervention. Self-directed VR use over the next 1 month was encouraged with additional PROs assessments at 1 and 4 weeks. Feasibility metrics included enrollment, eligibility, attrition, and device-related adverse effects with satisfaction measured with qualitative phone interviews. Fifty-five patients were approached via email, 40 (73%) responded and 20 (50%) enrolled (9 declines, 11 screen fails). 65% of participants were ≤ 50 years, 50% were male, 90% were White/non-Hispanic, 85% had good KPS (≥ 90), and most were on active treatment. All patients completed the VR intervention, PROs questionnaires, weekly check-ins, and qualitative interview. Most (90%) reported frequent VR use and high satisfaction and only 7 mild AEs were recorded (headache, dizziness, nausea, neck pain). This interim analysis supports feasibility and acceptability of a novel VR intervention to target psychological symptoms for PBT patients. Trial enrollment will continue to assess for intervention efficacy. NCT04301089 registered on 3/9/2020. The online version contains supplementary material available at 10.1007/s11060-023-04271-0.
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