Li Xinxin, Wu Xiaodan, Chen Chao, Chao Huaxiang, Xie Jingyue, Du Qianqian, Zhang Meifen
School of Nursing, Sun Yat-Sen University, Guangzhou, 510080, China.
State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, 510060, China.
BMC Cancer. 2024 Jul 17;24(1):847. doi: 10.1186/s12885-024-12583-1.
Significant concomitants of the sick role maladaptation in colorectal cancer (CRC) patients include inappropriate cognitions, emotional states, and overt conducts associated to disease. This protocol was developed to implement and evaluate the effects of a self-led, virtual reality-based cognitive behavioral therapy (VR-CBT) on the sick role adaptation among working-age CRC patients.
This is an assessor-blinded, randomized controlled trail that adheres to the SPIRIT 2013 Statement guidelines. A total of 60 working-age CRC patients will be recruited from the colorectal wards of a cancer center and randomly assigned to the VR-CBT group or attention control (AC) group. The VR-CBT group will receive a 7-sessions VR-CBT targeted to sick role adaptation, while the AC group will receive weekly attention at the same time the VR-CBT group receives the intervention. The sick role adaptation, anxiety and depression, illness perceptions, and quality of life will be measured at baseline, 1, 2 and 3-month after completion of the intervention. Side-effects related to VR in the VR-CBT group will be measured at the end of each session. The participants will receive invitations to participate in semi-structured interviews to explore their experiences with the intervention.
The positive outcomes and user experience of VR-CBT will advance researches on the effectiveness of psychosocial interventions that aims to promote adaptation to the unexpected sick role on cancer populations. This protocol can be tested as an accessible and feasible alternative to traditional high-cost treatment in a randomized controlled study to improve the outcomes of younger cancer survivors.
The protocol was registered on 21 June, 2023 in Chinese Clinical Trial Registry (No.: ChiCTR2300072699) at https://www.chictr.org.cn/ .
结直肠癌（CRC）患者患病角色适应不良的重要伴随因素包括与疾病相关的不恰当认知、情绪状态和公开行为。本方案旨在实施并评估一种基于虚拟现实的自我引导认知行为疗法（VR-CBT）对工作年龄CRC患者患病角色适应的影响。
这是一项遵循2013年SPIRIT声明指南的评估者盲法随机对照试验。将从一家癌症中心的结直肠病房招募60名工作年龄的CRC患者，并随机分配到VR-CBT组或注意力控制（AC）组。VR-CBT组将接受为期7次的针对患病角色适应的VR-CBT，而AC组将在VR-CBT组接受干预的同时每周接受相同时间的关注。将在基线、干预完成后1个月、2个月和3个月测量患病角色适应、焦虑和抑郁、疾病认知以及生活质量。VR-CBT组中与VR相关的副作用将在每次疗程结束时进行测量。参与者将收到参加半结构化访谈的邀请，以探讨他们对干预的体验。
VR-CBT的积极结果和用户体验将推动旨在促进癌症患者适应意外患病角色的心理社会干预效果的研究。本方案可在随机对照研究中作为传统高成本治疗的一种可及且可行的替代方案进行测试，以改善年轻癌症幸存者的结局。
该方案于2023年6月21日在中国临床试验注册中心（网址：https://www.chictr.org.cn/ ，注册号：ChiCTR2300072699）注册。
