Virtual Reality-Based Cognitive Intervention for Women With Cognitive Complaints Following Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Central Nervous System Vital Signs (CNSVS)
研究概览
简要总结
The aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women treated for breast cancer.
详细描述
Cognitive dysfunction is a kind of cluster of commonly reported neurotoxic symptoms following cancer diagnosis and treatment, especially chemotherapy. Our previous studies found that breast cancer patients and survivors had greater difficulties in performing attention, working memory, and executive function tasks and had persistent neural inefficiency of an executive network of the brain than disease and treatment counterparts.
The aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women with cognitive complaints after breast cancer treatment. All participants will receive the initial screening to verify their cognitive status and then will be randomly assigned to the experimental or control group. The experimental group will receive a 4-week cognitive intervention by using a VR headset. Each VR content includes 10-12 video scenes with visual and auditory stimuli that were generated from nature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being treated with chemotherapy for breast cancer
- •Having affirmative responses to three questions about cognitive problems and their impact on daily performance
- •Having FACT-Cog scores of 58 or less
- •Having Mini-Cog scores of 3 and higher
- •Having the ability to read, understand or respond to questionnaires and cognitive assessment
- •Being willing to participate and able to provide written informed consent
排除标准
- •Having metastatic breast cancer
- •Having Patient Health Questionnaire-2 score of 3 and higher
- •Being diagnosed with neurological disorders such as dementia, multiple sclerosis, or traumatic brain injury
- •Having epilepsy or seizure
- •Having 'quite a bit' or 'extremely' severe level of nausea and vomiting
- •Having visual or hearing impairments
- •Having other problems that prevent them from wearing the VR headset
结局指标
主要结局
Central Nervous System Vital Signs (CNSVS)
时间窗: Cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
The CNSVS will be used to assess global and domain-specific cognitive function
Functional Assessment of Cancer Therapy-Cognitive
时间窗: Perceived cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
The FACT-Cog will be used to assess self-reported effectiveness in cognitive function
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(Sleep problems will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention))
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(Fatigue will will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention))
- Patient Health Questionnaire (PHQ)(Depression will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention))
- Functional Assessment of Cancer Therapy-General (FACT-G)(Quality of life will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention))
- Perceived Restorativeness for Activities Scale (PRAS)(Perceived restorativeness will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention))
研究者
Mi Sook Jung
Associate professor
Chungnam National University