Smart Virtual Reality Mindfulness System for Breast Cancer Chemotherapy: Integrating Stress Reduction Combined Multimodal Biofeedback and Clinical Effectiveness Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- stress perception
研究概览
简要总结
Breast cancer patients undergoing chemotherapy often face significant physical and emotional symptoms, with stress contributing to symptom severity. This study investigates the effectiveness of a mindfulness-based virtual reality (VR) intervention in reducing stress and symptom severity. A total of 60 participants will be stratified and randomized into three groups: mindfulness-based VR, mindfulness-based audio, and control. Data will be analyzed using generalized estimating equations and machine learning. The goal is to improve understanding and quality of care for cancer patients by evaluating the potential benefits of mindfulness-based VR interventions.
详细描述
Background: Breast cancer patients undergoing chemotherapy commonly experience physical and emotional symptoms, with approximately 90 percent of patients being affected. Perceived stress is one of the related factors that can contribute to symptom severity. Inadequate control of symptoms can have significant negative consequences on patient's quality of life, treatment adherence, disease prognosis, and increase the number of doctor visits, and overall treatment outcomes. The application of virtual reality in improving symptoms and perceived stress in breast cancer patients undergoing chemotherapy is an area of ongoing research, and the findings from existing studies have been inconsistent. Additionally, the incorporation of mindfulness techniques within VR interventions for this specific population has been limited.
Objective
This study aims to explore the effectiveness of mindfulness-based virtual reality on the stress perception and symptom severity of breast cancer patients undergoing chemotherapy.
Methods: Stratified block randomization will be used to assign 20 patients each to the mindfulness based virtul reality group, the mindfulness based audio practice group, and the control group, totaling 60 participants. Data analysis will be conducted using the generalized estimating equation and machine learning.
Expected results: To understand the effectiveness of mindfulness-based virtual reality on the stress perception and the symptoms severity of chemotherapy in breast cancer patients, in order to serve as a reference for improving the quality of care for cancer patients in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The Outcomes Assessor will perform physiological data extraction and questionnaire result analysis without knowledge of the group assignments of the data being analyzed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years.
- •Diagnosed with breast cancer stages I to III, with diagnostic codes C50, C79.81, C84.7A, D03.52, D05, D24, D48, or D49; there are no restrictions on tumor type, receptor subtype, or whether breast tumor removal surgery has been performed.
- •Undergoing the first inpatient preoperative or postoperative chemotherapy, without restrictions on the type of medication or treatment cycles.
- •Able to communicate in Mandarin and literate; without cognitive impairments, psychiatric disorders, motion sickness, epilepsy, or a history of drug or alcohol addiction.
- •No prior experience with mindfulness-based interventions. Understanding of the research procedures, agreement to participate, and signing of the informed consent form; owning a smartphone capable of installing the required research applications and able to operate independently.
排除标准
- •individuals with blindness or visual impairments that preclude the identification of on-screen visuals
- •individuals with auditory impairments preventing the recognition of sounds through headphones.
结局指标
主要结局
stress perception
时间窗: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
The Revised Newly Diagnosed Breast Cancer Stress Scale (NDBCSS-R) will be used: This scale consists of 17 items, divided into four parts: Negative Perception (3 items), Threat (4 items), Unpredictability (5 items), and Facing Challenge (4 items). Scoring is based on a 4-point Likert scale, with 3 indicating strong agreement and 0 indicating disagreement. Higher scores indicate a greater level of perceived stress. Items 1, 3, 5, 11, 13, and 15 are reverse-scored.
Mindfulness efficacy
时间窗: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) will be used: It consists of 10 items, rated on a 4-point scale, with 1 indicating almost never and 4 indicating almost always. Higher scores indicate a higher level of mindfulness.
symptom severity
时间窗: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
The Memorial Symptom Assessment Scale (MSAS) will be used: It consists of 32 items. First, participants indicate the presence or absence of symptoms. If symptoms are present, the frequency, severity, and distress of 24 symptoms, and the severity and distress of 8 symptoms, are evaluated. Frequency and severity are assessed using a 4-point scale, with 1 indicating rarely or mild and 4 indicating almost constantly or very severe. If there are no symptoms, the item is scored as 0. Distress is assessed using a 5-point scale, with 0 indicating not at all and 4 indicating very much.
次要结局
- heart rate variability(Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks))
- Respiration pattern variability(Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks))
- Electroencephalogram(Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks))
- Electrodermal Activity(Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks))
- Salivary cortisol concentration(Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks))
研究者
Hsin Yi Lu
Register Nurse
Tri-Service General Hospital