Brief Mindfulness Chatbot Intervention for Cancer Patients

NCT07811739 | Not Yet Recruiting

• 1 other identifier: TMU-MINDBOT-CA-2026
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cancer; Stress, Psychological

Keywords

Mindfulness; Chatbot; LINE (Messaging App); Virtual Reality; Heart Rate Variability; Salivary Cortisol; Brief Mindfulness Intervention; Digital Health; Cancer-Related Fatigue

Outcome Measures

Primary Outcomes (4)

• Change in Perceived Stress

  Perceived stress assessed using the Chinese version of the Perceived Stress Scale (PSS-10). Higher scores indicate greater perceived stress.

  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.

  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.

  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).

  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 (2)

• 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)

Study Arms (2)

Mindbot Brief Mindfulness Chatbot

EXPERIMENTAL

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

Other: Usual Care

NO INTERVENTION

Interventions

Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality BEHAVIORAL

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.

Mindbot Brief Mindfulness Chatbot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead
• Shin Kong Wu Ho-Su Memorial Hospital: collaborator

MeSH Terms

Conditions

Neoplasms; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are allocated 1:1 to two parallel groups using random permuted blocks of mixed sizes 4 and 6, generated via an online randomization system (Sealed Envelope Simple Randomiser).

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share