An interventional study of Mobile Remote Mindfulness Breathing Training and Brief Mindfulness Breathing Instruction in Cancer, sponsored by Tri-Service General Hospital (TSGH). Not yet recruiting at 2 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Tri-Service General Hospital (TSGH) · Not applicable, Interventional, and Supportive care
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Tri-Service General Hospital (TSGH) is the lead sponsor of 38 studies on the registry; 12 are open to participants now.
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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.
Exclusion Criteria:
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.
Participants will complete 5 to 10 minutes of guided mobile-delivered remote mindfulness breathing practice daily for 3 weeks, in addition to usual care.
Behavioral: Mobile Remote Mindfulness Breathing Training
Participants will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
Behavioral: Brief Mindfulness Breathing Instruction
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.
Participants will receive one approximately 5-minute mindfulness breathing stress-reduction instruction session in addition to usual care.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 3
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 14 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Tri-Service General Hospital (TSGH)