An interventional study of Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality in Cancer and Stress, Psychological, sponsored by Taipei Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Supportive care
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.
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.
Outcome assessment: Primary outcomes (mindfulness level, perceived stress, HRV, salivary cortisol) and secondary outcomes (fatigue, cancer symptom severity) are assessed at baseline (T0, at enrollment), hospital discharge (T2), and the first outpatient follow-up visit (T3). Salivary cortisol is additionally sampled four times daily (on waking, 30 minutes post-waking, afternoon, and late evening) throughout the intervention period. Qualitative feedback shared by participants through the LINE chat interface is de-identified, transcribed, and analyzed using content analysis to complement the quantitative findings.
10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 7,704 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Taipei Medical University is the lead sponsor of 257 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality
A LINE chatbot ("Mindbot") delivering a 10-minute structured brief mindfulness session (breath awareness, body scan, and mindful acceptance of ambient hospital sounds) combined with virtual reality (VR)-guided audio-visual content. Automated push notifications are sent daily at 13:00 and 21:00. Participants complete pre- and post-session assessments of symptom severity and 7-minute heart rate variability (HRV) measurements before and after each practice session.
Change in Perceived Stress
Perceived stress assessed using the Chinese version of the Perceived Stress Scale (PSS-10). Higher scores indicate greater perceived stress.
Time frame: 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 Mindfulness Level
Mindfulness level assessed using the Chinese version of the Mindful Attention Awareness Scale (CMAAS). Higher scores indicate greater mindfulness.
Time frame: 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 Heart Rate Variability (HRV)
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.
Time frame: Before and after each daily practice session during hospitalization; and at baseline, hospital discharge, and first outpatient follow-up (approximately 4 weeks after discharge)
Change in Salivary Cortisol Concentration
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).
Time frame: 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)
Change in Fatigue
Fatigue assessed using the Taiwanese version of the Brief Fatigue Inventory (BFI-T). Higher scores indicate greater fatigue severity.
Time frame: 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
Cancer-related symptom severity assessed using the Edmonton Symptom Assessment Scale-Revised (ESAS-r). Higher scores indicate greater symptom burden. Assessed before and after each daily practice session (experimental arm), as well as at baseline, hospital discharge, and first outpatient follow-up.
Time frame: Before and after each daily practice session during hospitalization; and at baseline, hospital discharge, and first outpatient follow-up (approximately 4 weeks after discharge)
No study locations are listed for this record.
Plan to share: No
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Start is estimated for Nov 2026; primary completion for Jul 2028, 20 months later.
Of 1,983 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 20 months is below that.
Counting every sponsor, half of 2,058 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
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