Brief Mindfulness Chatbot Intervention for Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality
BehavioralA 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Mindbot Brief Mindfulness ChatbotExperimental treatment 1 intervention
Group B: Other: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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)2
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Taipei Medical University
Lead sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborator
Source ClinicalTrials.gov
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