CancerNCT07806760
Remote Mindfulness Breathing Training for Patients Undergoing Chemotherapy
A study testing Mobile Remote Mindfulness Breathing Training and Brief Mindfulness Breathing Instruction in people with Cancer, run by Tri-Service General Hospital (TSGH) at 2 sites in Taiwan.
Trial summary
This randomized controlled trial will evaluate the effects of a mobile-delivered remote mindfulness breathing training program on symptom distress, fatigue, anxiety, and depression in adults with cancer who are receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Mobile Remote Mindfulness Breathing Training and Brief Mindfulness Breathing Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Oct 2026to 31 Dec 2027
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 years or older with full legal capacity. Diagnosed with any type of cancer and currently receiving chemotherapy as an inpatient or at the Tri-Service General Hospital breast surgery outpatient clinic.
- Able to understand Chinese or Taiwanese and able to read and operate a smartphone or tablet.
- Willing to participate in the study and accept random assignment. Have access to a personal mobile device capable of accessing the study materials.
Who cannot join
- Severe psychiatric disorders, such as schizophrenia or bipolar disorder, or neurodegenerative diseases, such as moderate or severe dementia.
- Clinical deterioration or poor prognosis requiring a change in treatment or transition to palliative or hospice care.
- Concurrent participation in another psychological intervention study that may affect emotional outcomes.
- Deemed unsuitable for breathing training or receiving prolonged sedation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites
Tri-Service General Hospital Songshan Branch
Taipei, Taipei City, 105
Lei-Yu Chen, +886-2-2764-2151 ext. 671419, leiyu841125@gmail.com
Tri-Service General Hospital
Taipei, Taipei City, 114
Lei-Yu Chen, +886-2-2764-2151 ext. 671419, leiyu841125@gmail.com
About this study
Official title: Effects of Remote Mindfulness Breathing Training on Symptom Distress, Fatigue and Psychological Well-Being in Patients Undergoing Chemotherapy
This randomized controlled trial will evaluate the effects of a mobile-delivered remote mindfulness breathing training program on symptom distress, fatigue, anxiety, and depression in adults with cancer who are receiving chemotherapy.
A total of 80 participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. The intervention group will complete 5 to 10 minutes of guided mindfulness breathing practice each day for 3 weeks using a mobile-accessible video. The control group will receive usual care and one approximately 5-minute mindfulness breathing instruction session. Outcomes will be assessed at baseline and at the end of the 3-week intervention.
Read the detailed description
This study is a prospective, two-arm, assessor-blinded randomized controlled trial involving adults with any type of cancer who are receiving chemotherapy in inpatient units or at the Tri-Service General Hospital breast surgery outpatient clinic.
After providing written informed consent and completing the baseline assessment, eligible participants will be randomly allocated by computer in a 1:1 ratio to the intervention group or the control group. The intervention group will receive a mobile-delivered remote mindfulness breathing training program and will be instructed to practice with a guided video for approximately 5 to 10 minutes daily for 3 weeks. The control group will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
Study assessments will be conducted before the intervention and at the end of week 3. Symptom distress will be assessed using the National Comprehensive Cancer Network Distress Thermometer, fatigue using the Brief Fatigue Inventory, anxiety using the Generalized Anxiety Disorder-7, and depression using the Patient Health Questionnaire-9. To reduce measurement bias, the post-intervention assessment will be conducted by a research assistant who is unaware of the participants' group assignments.
- Conditions
- Cancer
- Being tested
- Mobile Remote Mindfulness Breathing Training, Brief Mindfulness Breathing Instruction
- Keywords
- Mindfulness, Breathing Exercise, Cancer-Related Fatigue, Symptom Distress, Anxiety, Depression, Mobile Health, Chemotherapy
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Remote Mindfulness Breathing TrainingBehavioural
Participants will use a mobile-accessible guided video to practice mindfulness awareness combined with slow diaphragmatic breathing for approximately 5 to 10 minutes daily for 3 weeks during chemotherapy, in addition to usual care.
Brief Mindfulness Breathing InstructionBehavioural
Participants will receive one approximately 5-minute mindfulness breathing stress-reduction instruction session in addition to usual care.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Remote Mindfulness Breathing Training | Experimental | Participants will complete 5 to 10 minutes of guided mobile-delivered remote mindfulness breathing practice daily for 3 weeks, in addition to usual care. Receives: Behavioral: Mobile Remote Mindfulness Breathing Training |
| Brief Mindfulness Breathing Instruction | Active comparator | Participants will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session. Receives: Behavioral: Brief Mindfulness Breathing Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Distress Level Assessed by the NCCN Distress Thermometer
The NCCN Distress Thermometer is a single-item self-report scale ranging from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater distress.
Measured: Baseline and Week 3
Change in Fatigue Assessed by the Brief Fatigue Inventory
The Brief Fatigue Inventory contains 9 items rated from 0 to 10. The global fatigue score is calculated as the mean of the completed items, with higher scores indicating greater fatigue severity and interference.
Measured: Baseline and Week 3
Change in Anxiety Assessed by the Generalized Anxiety Disorder-7
The Generalized Anxiety Disorder-7 contains 7 items rated from 0 to 3, producing a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity.
Measured: Baseline and Week 3
Change in Depression Assessed by the Patient Health Questionnaire-9
The Patient Health Questionnaire-9 contains 9 items rated from 0 to 3, producing a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity.
Measured: Baseline and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Lei Yu, Tri-Service General Hospital (TSGH)
- Investigators
- Lei-Yu Chen, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806760
- Sponsor's protocol ID
- MB-2026-01
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Mindfulness Breathing Training on Symptom Distress, Fatigue and Psychological Well-Being in Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07806760
- Acronym / sponsor ID
- MB-2026-01
- Conditions
- Cancer
- Keywords
- Mindfulness, Breathing Exercise, Cancer-Related Fatigue, Symptom Distress, Anxiety, Depression, Mobile Health, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will evaluate the effects of a mobile-delivered remote mindfulness breathing training program on symptom distress, fatigue, anxiety, and depression in adults with cancer who are receiving chemotherapy.
A total of 80 participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. The intervention group will complete 5 to 10 minutes of guided mindfulness breathing practice each day for 3 weeks using a mobile-accessible video. The control group will receive usual care and one approximately 5-minute mindfulness breathing instruction session. Outcomes will be assessed at baseline and at the end of the 3-week intervention.
Detailed description
This study is a prospective, two-arm, assessor-blinded randomized controlled trial involving adults with any type of cancer who are receiving chemotherapy in inpatient units or at the Tri-Service General Hospital breast surgery outpatient clinic.
After providing written informed consent and completing the baseline assessment, eligible participants will be randomly allocated by computer in a 1:1 ratio to the intervention group or the control group. The intervention group will receive a mobile-delivered remote mindfulness breathing training program and will be instructed to practice with a guided video for approximately 5 to 10 minutes daily for 3 weeks. The control group will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
Study assessments will be conducted before the intervention and at the end of week 3. Symptom distress will be assessed using the National Comprehensive Cancer Network Distress Thermometer, fatigue using the Brief Fatigue Inventory, anxiety using the Generalized Anxiety Disorder-7, and depression using the Patient Health Questionnaire-9. To reduce measurement bias, the post-intervention assessment will be conducted by a research assistant who is unaware of the participants' group assignments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Remote Mindfulness Breathing Training | Experimental | Behavioral: Mobile Remote Mindfulness Breathing TrainingParticipants will complete 5 to 10 minutes of guided mobile-delivered remote mindfulness breathing practice daily for 3 weeks, in addition to usual care. |
| Brief Mindfulness Breathing Instruction | Active comparator | Behavioral: Brief Mindfulness Breathing InstructionParticipants will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 20 years or older with full legal capacity. Diagnosed with any type of cancer and currently receiving chemotherapy as an inpatient or at the Tri-Service General Hospital breast surgery outpatient clinic.
- Able to understand Chinese or Taiwanese and able to read and operate a smartphone or tablet.
- Willing to participate in the study and accept random assignment. Have access to a personal mobile device capable of accessing the study materials.
Key exclusion criteria (4 listed)
- Severe psychiatric disorders, such as schizophrenia or bipolar disorder, or neurodegenerative diseases, such as moderate or severe dementia.
- Clinical deterioration or poor prognosis requiring a change in treatment or transition to palliative or hospice care.
- Concurrent participation in another psychological intervention study that may affect emotional outcomes.
- Deemed unsuitable for breathing training or receiving prolonged sedation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Remote Mindfulness Breathing TrainingParticipants will use a mobile-accessible guided video to practice mindfulness awareness combined with slow diaphragmatic breathing for approximately 5 to 10 minutes daily for 3 weeks during chemotherapy, in addition to usual care. | Behavioural | Mobile Remote Mindfulness Breathing Training |
| Brief Mindfulness Breathing InstructionParticipants will receive one approximately 5-minute mindfulness breathing stress-reduction instruction session in addition to usual care. | Behavioural | Brief Mindfulness Breathing Instruction |
Primary outcome
Change in Distress Level Assessed by the NCCN Distress Thermometer
Time frame: Baseline and Week 3
The NCCN Distress Thermometer is a single-item self-report scale ranging from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater distress.
Change in Fatigue Assessed by the Brief Fatigue Inventory
Time frame: Baseline and Week 3
The Brief Fatigue Inventory contains 9 items rated from 0 to 10. The global fatigue score is calculated as the mean of the completed items, with higher scores indicating greater fatigue severity and interference.
Change in Anxiety Assessed by the Generalized Anxiety Disorder-7
Time frame: Baseline and Week 3
The Generalized Anxiety Disorder-7 contains 7 items rated from 0 to 3, producing a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity.
Change in Depression Assessed by the Patient Health Questionnaire-9
Time frame: Baseline and Week 3
The Patient Health Questionnaire-9 contains 9 items rated from 0 to 3, producing a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei-Yu Chen principal investigator
Tri-Service General Hospital (TSGH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Remote Mindfulness Breathing Training and Brief Mindfulness Breathing Instruction in people with Cancer, run by Tri-Service General Hospital (TSGH) at 2 sites in Taiwan.
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 3 inclusion and 4 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Lei-Yu Chen (+886-2-2764-2151 ext. 671419, leiyu841125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Distress Level Assessed by the NCCN Distress Thermometer (time frame: Baseline and Week 3). 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 8 Sep 2026.