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AzTrials

CancerMINDBOT-CANCT07811739

Brief Mindfulness Chatbot Intervention for Cancer Patients

A study testing Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality in people with Cancer and Stress, Psychological, run by Taipei Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Stress, Psychological
What is being tested?
Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality
Keywords
Mindfulness, Chatbot, LINE (Messaging App), Virtual Reality, Heart Rate Variability, Salivary Cortisol, Brief Mindfulness Intervention, Digital Health, Cancer-Related Fatigue
Medical subject headings
Neoplasms, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual RealityBehavioural

    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.

Study groups in NCT07811739
Study groupRoleWhat they receive
Mindbot Brief Mindfulness ChatbotExperimentalParticipants 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.
Receives: Behavioral: Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality
Other: Usual CareNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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)
  1. Change in Fatigue

    Fatigue assessed using the Taiwanese version of the Brief Fatigue Inventory (BFI-T). Higher scores indicate greater fatigue severity.

    Measured: 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.

    Measured: Before and after each daily practice session during hospitalization; and at baseline, hospital discharge, and first outpatient follow-up (approximately 4 weeks after discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811739
Sponsor's protocol ID
TMU-MINDBOT-CA-2026
Acronym
MINDBOT-CA
Status last verified
Jul 2026
First submitted
23 Jul 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindbot: Brief Mindfulness-Based LINE Chatbot with Virtual Reality in people with Cancer and Stress, Psychological, run by Taipei Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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