Cancer
Conditions
Keywords
Mindfulness, Breathing Exercise, Cancer-Related Fatigue, Symptom Distress, Anxiety, Depression, Mobile Health, Chemotherapy
Brief 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. 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.
Interventions
BEHAVIORALMobile Remote Mindfulness Breathing Training
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.
BEHAVIORALBrief Mindfulness Breathing Instruction
Participants will receive one approximately 5-minute mindfulness breathing stress-reduction instruction session in addition to usual care.
Sponsors
Tri-Service General Hospital (TSGH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Assessed by the Patient Health Questionnaire-9 | 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. |
| Change in Distress Level Assessed by the NCCN Distress Thermometer | 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 | 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 | 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. |
Countries
Taiwan
Contacts
CONTACTLei-Yu Chen
PRINCIPAL_INVESTIGATORLei-Yu Chen
Tri-Service General Hospital (TSGH)
Outcome results
None listed