Background: A virtual reality experience (VRE) could represent a viable non-pharmacological intervention to reduce and better manage the main factors of psychophysical distress related to the diagnosis and treatment of cancer. Aim: The "Patient's Dream" study was a two-arm randomized controlled trial conducted at the Regina Elena National Cancer Institute – IRCCS (Rome, Italy) from April 2019 to January 2020 to evaluate VRE impact in patients affected by breast or ovarian cancer. Before starting the first cycle of chemotherapy (CT), patients were randomized to receive the VRE (VRE arm) as "distraction therapy" or to entertain themselves with conventional means (control arm). The primary aims were the assessment of psychological distress, anxiety and quality of life between the two study arms. Secondary endpoints were the perceived time during the first course of CT and the acute and late toxicity. Results: Collected data underline the absence of prevalent disturbs of anxiety and depression in both groups. Nevertheless, even if the state anxiety values before and after CT decreased in both groups, this reduction was statistically significant over time only in the VRE arm. The duration of therapy perceived by patients undergoing distraction therapy was significantly shorter when compared to the control group. The use of VRE during the first CT cycle appeared to reduce asthenia outcomes. Conclusion: Obtained data suggest that the VRE positively influenced the levels of state anxiety among cancer patients and support the continuous research on VRE as a distraction intervention, with the aim to meet the clinical need for effective nonpharmacologic adjunctive therapies. Trial registration: NCT05234996

背景：虚拟现实体验 (VRE) 可以代表一种可行的非药物干预措施，以减少和更好地管理与癌症诊断和治疗相关的心理生理困扰的主要因素。目的：“患者的梦想”研究是 2019 年 4 月至 2020 年 1 月在 Regina Elena National Cancer Institute – IRCCS（意大利罗马）进行的一项双臂随机对照试验，旨在评估 VRE 对乳腺癌或卵巢癌患者的影响。在开始第一个化疗周期 (CT) 之前，患者被随机分配接受 VRE（VRE 组）作为“分心疗法”或以常规方式自娱自乐（对照组）。主要目的是评估两个研究组之间的心理困扰、焦虑和生活质量。次要终点是 CT 第一个疗程的感知时间以及急性和晚期毒性。结果：收集的数据强调了两组中普遍存在的焦虑和抑郁障碍。然而，即使两组 CT 前后的状态焦虑值均有所下降，但这种下降仅在 VRE 组中随时间推移具有统计学意义。与对照组相比，接受分心治疗的患者感知到的治疗持续时间明显缩短。在第一个 CT 周期中使用 VRE 似乎可以减少乏力的结果。结论：获得的数据表明，VRE 正向影响癌症患者的状态焦虑水平，并支持对 VRE 作为分心干预的持续研究，旨在满足临床对有效的非药物辅助治疗的需求。试用注册：NCT05234996