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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
80
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.
Tri-Service General Hospital Songshan Branch
Taipei, Taipei City, Taiwan
Tri-Service General Hospital
Taipei, Taipei City, Taiwan
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
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