Remote Mindfulness Breathing Training for Patients Undergoing Chemotherapy

September 1, 2026 updated by: Chen Lei Yu, Tri-Service General Hospital (TSGH)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taipei City
      • Taipei, Taipei City, Taiwan, 105
        • Tri-Service General Hospital Songshan Branch
        • Contact:
      • Taipei, Taipei City, Taiwan, 114
        • Tri-Service General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Remote Mindfulness Breathing Training
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 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.
Active Comparator: Brief Mindfulness Breathing Instruction
Participants will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
Behavioral: Brief Mindfulness Breathing Instruction
Participants will receive one approximately 5-minute mindfulness breathing stress-reduction instruction session in addition to usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 3
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.
Baseline and Week 3
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.
Baseline and Week 3
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.
Baseline and Week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital (TSGH)

Investigators

  • Principal Investigator: Lei-Yu Chen, Tri-Service General Hospital (TSGH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 1, 2026

First Submitted That Met QC Criteria

September 1, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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