Brief Mindfulness Chatbot Intervention for Cancer Patients (MINDBOT-CA)
Effects of a Brief Mindfulness-Based Chatbot Intervention (Mindbot) on Mindfulness Level and Stress Among Cancer Patients: A Randomized Controlled 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
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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.
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Aucune intervention: Other: Usual Care
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Perceived Stress
Délai: 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)
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Perceived stress assessed using the Chinese version of the Perceived Stress Scale (PSS-10).
Higher scores indicate greater perceived stress.
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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)
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Change in Mindfulness Level
Délai: 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)
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Mindfulness level assessed using the Chinese version of the Mindful Attention Awareness Scale (CMAAS).
Higher scores indicate greater mindfulness.
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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)
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Change in Heart Rate Variability (HRV)
Délai: Before and after each daily practice session during hospitalization; and at baseline, hospital discharge, and first outpatient follow-up (approximately 4 weeks after discharge)
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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.
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Before and after each daily practice session during hospitalization; and at baseline, hospital discharge, and first outpatient follow-up (approximately 4 weeks after discharge)
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Change in Salivary Cortisol Concentration
Délai: 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)
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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).
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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)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Fatigue
Délai: 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)
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Fatigue assessed using the Taiwanese version of the Brief Fatigue Inventory (BFI-T).
Higher scores indicate greater fatigue severity.
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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)
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Change in Cancer Symptom Severity
Délai: Before and after each daily practice session during hospitalization; and at baseline, hospital discharge, and first outpatient follow-up (approximately 4 weeks after discharge)
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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.
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Before and after each daily practice session during hospitalization; and at baseline, hospital discharge, and first outpatient follow-up (approximately 4 weeks after discharge)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TMU-MINDBOT-CA-2026
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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