Effects of a Brief Mindfulness-Based Chatbot Intervention (Mindbot) on Mindfulness Level and Stress Among Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Change in Perceived Stress
研究概览
简要总结
This study tests a new digital tool for hospitalized cancer patients. The tool is a chatbot on LINE, a popular messaging app. The chatbot is called Mindbot. Mindbot leads a 10-minute mindfulness practice each day. The practice uses breathing exercises and virtual reality (VR).
Adult cancer patients in the hospital ward can join. Participants are randomly placed into one of two groups. One group uses Mindbot every day during their hospital stay. The other group receives usual hospital care through the hospital's existing health app.
Researchers measure mindfulness, stress, and heart rate variability (a measure of body stress) before and after each practice. They also collect saliva samples to check a stress hormone called cortisol. Researchers track fatigue and cancer symptoms too. These measurements happen at three time points: hospital admission, hospital discharge, and the first follow-up clinic visit.
详细描述
Psychological distress is common among hospitalized cancer patients and, if unmanaged, may negatively affect quality of life and disease trajectory. Traditional mindfulness-based stress reduction programs require prolonged daily practice (e.g., 45 minutes over 8 weeks) and show low adherence in this population, largely due to cancer-related fatigue. Brief mindfulness sessions (10-20 minutes) delivered via widely-used instant messaging platforms may improve accessibility and adherence compared with standalone apps or websites that require additional learning effort.
This is a two-arm, parallel-group randomized controlled trial evaluating a LINE chatbot-delivered brief mindfulness intervention (Mindbot) combined with VR-guided audio-visual content, compared with usual care, among cancer patients admitted to a hospital ward at a medical center in northern Taiwan.
Randomization: Participants are allocated 1:1 using an online randomizer (Sealed Envelope Simple Randomiser) with random permuted blocks of mixed sizes 4 and 6. The allocation sequence is generated by an independent researcher not involved in recruitment, and allocation results are concealed in sequentially numbered, opaque sealed envelopes until after consent and eligibility confirmation. To reduce cross-contamination among roommates in shared hospital rooms, all participants in the same room are assigned to the same study arm.
Blinding: Because the intervention is delivered via a distinguishable QR code (chatbot vs. existing hospital app), participants and on-site research staff cannot be blinded to allocation. After data de-identification and re-coding, the statistician performing the primary analysis is blinded to actual group assignment until the primary analysis is complete.
Intervention: The experimental arm receives automated push notifications at 13:00 and 21:00 daily, prompting a 10-minute structured mindfulness session (breath awareness, body scan, and mindful acceptance of hospital ambient sounds), guided by the virtual character "Mindbot" in a VR environment. Each session includes a pre- and post-practice assessment of cancer symptom severity and a 7-minute resting heart rate variability (HRV) measurement. The control arm receives usual hospital care and access to the hospital's existing health management app, which provides general disease-related e-education without mindfulness content.
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
- Single (Outcomes Assessor)
盲法说明
Although this study is open-label with respect to participants and on-site research staff (the intervention is delivered via a distinguishable QR code), the biostatistician performing the primary analysis is blinded to group assignment. After data de-identification, outcome data are re-coded (e.g., Group A/B) before being provided to the statistician, who remains unaware of which code corresponds to which study arm until after the primary analysis is completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •Diagnosed with cancer
- •Able to use a smartphone and operate LINE (either the participant themselves or their caregiver)
- •Able to communicate and read in Mandarin Chinese
排除标准
- •Physician-diagnosed severe psychiatric disorder or cognitive impairment that may affect comprehension of study content or ability to complete questionnaires
- •Currently participating in another psychotherapy or mindfulness training program
研究组 & 干预措施
Mindbot Brief Mindfulness Chatbot
Participants receive a LINE chatbot ("Mindbot") delivering a 10-minute structured brief mindfulness session (breath awareness, body scan, and mindful acceptance of ambient sounds) combined with virtual reality (VR)-guided audio-visual content, with automated push reminders at 13:00 and 21:00 daily, for the duration of their hospital stay.
干预措施: Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality (Behavioral)
Other: Usual Care
结局指标
主要结局
Change in Perceived Stress
时间窗: Baseline (within 24 hours of enrollment), at hospital discharge (variable, depending on length of stay), and at the first outpatient follow-up visit (approximately 4 weeks after discharge)
Perceived stress assessed using the Chinese version of the Perceived Stress Scale (PSS-10). Higher scores indicate greater perceived stress.
Change in Mindfulness Level
时间窗: Baseline (within 24 hours of enrollment), at hospital discharge (variable, depending on length of stay), and at the first outpatient follow-up visit (approximately 4 weeks after discharge)
Mindfulness level assessed using the Chinese version of the Mindful Attention Awareness Scale (CMAAS). Higher scores indicate greater mindfulness.
Change in Heart Rate Variability (HRV)
时间窗: Before and after each daily practice session during hospitalization; and at baseline, hospital discharge, and first outpatient follow-up (approximately 4 weeks after discharge)
Heart rate variability measured using a validated HRV monitor during a 7-minute resting assessment, used as an objective physiological indicator of stress. Measured before and after each daily 10-minute mindfulness practice session (experimental arm), as well as at baseline, hospital discharge, and first outpatient follow-up.
Change in Salivary Cortisol Concentration
时间窗: Four times daily (upon waking, 30 minutes post-waking, afternoon, and late evening), from enrollment through hospital discharge, an average of 4 days (range 3-5 days)
Salivary cortisol concentration measured as an objective biomarker of physiological stress. Saliva samples are self-collected at four time points daily: upon waking, 30 minutes after waking, in the afternoon (approximately 15:00), and in the late evening (approximately 22:00-23:00).
次要结局
- Change in Fatigue(Baseline (within 24 hours of enrollment), at hospital discharge (variable, depending on length of stay), and at the first outpatient follow-up visit (approximately 4 weeks after discharge))
- Change in Cancer Symptom Severity(Before and after each daily practice session during hospitalization; and at baseline, hospital discharge, and first outpatient follow-up (approximately 4 weeks after discharge))
研究者
Tsai-Wei Huang
Professor
Taipei Medical University