Remote Mindfulness Breathing Training for Patients Undergoing Chemotherapy

NCT07806760 | Not Yet Recruiting

• 1 other identifier: MB-2026-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

Mindfulness; Breathing Exercise; Cancer-Related Fatigue; Symptom Distress; Anxiety; Depression; Mobile Health; Chemotherapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline and Week 3

Study Arms (2)

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.

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.

Behavioral: Brief Mindfulness Breathing Instruction

Interventions

Mobile Remote Mindfulness Breathing Training BEHAVIORAL

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.

Mobile Remote Mindfulness Breathing Training

Brief Mindfulness Breathing Instruction BEHAVIORAL

Participants will receive one approximately 5-minute mindfulness breathing stress-reduction instruction session in addition to usual care.

Brief Mindfulness Breathing Instruction

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital (TSGH): lead

Study Sites (2)

Tri-Service General Hospital Songshan Branch

Taipei, Taipei City, 105, Taiwan

Location

Tri-Service General Hospital

Taipei, Taipei City, 114, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lei-Yu Chen

  Tri-Service General Hospital (TSGH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei-Yu Chen

CONTACT

+886-2-2764-2151; leiyu841125@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head Nurse, Outpatient Department

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)