Mindfulness-based virtual reality for breast cancer patients undergoing chemotherapy
Smart Virtual Reality Mindfulness System for Breast Cancer Chemotherapy: Integrating Stress Reduction Combined Multimodal Biofeedback and Clinical Effectiveness Evaluation
This study is testing if a mindfulness-based virtual reality program can help breast cancer patients undergoing chemotherapy feel less stressed and manage their symptoms better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Tri-Service General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taipei, Neihu Distinct) |
| Trial ID | NCT06541587 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a mindfulness-based virtual reality (VR) intervention aimed at reducing stress and symptom severity in breast cancer patients undergoing chemotherapy. A total of 60 participants will be randomly assigned to one of three groups: mindfulness-based VR, mindfulness-based audio, or a control group. The study will utilize stratified block randomization and analyze data using generalized estimating equations and machine learning techniques. The goal is to enhance understanding and improve the quality of care for cancer patients by evaluating the potential benefits of mindfulness-based VR interventions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with stages I to III breast cancer who are undergoing their first chemotherapy treatment.
Not a fit: Patients with cognitive impairments, psychiatric disorders, or those who have prior experience with mindfulness-based interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce stress and improve the quality of life for breast cancer patients undergoing chemotherapy.
How similar studies have performed: While existing studies on virtual reality and mindfulness for cancer patients have shown inconsistent results, this specific approach integrating both techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age above 18 years. * Diagnosed with breast cancer stages I to III, with diagnostic codes C50, C79.81, C84.7A, D03.52, D05, D24, D48, or D49; there are no restrictions on tumor type, receptor subtype, or whether breast tumor removal surgery has been performed. * Undergoing the first inpatient preoperative or postoperative chemotherapy, without restrictions on the type of medication or treatment cycles. * Able to communicate in Mandarin and literate; without cognitive impairments, psychiatric disorders, motion sickness, epilepsy, or a history of drug or alcohol addiction. * No prior experience with mindfulness-based interventions. Understanding of the research procedures, agreement to participate, and signing of the informed consent form; owning a smartphone capable of installing the required research applications and able to operate independently. Exclusion Criteria: * individuals with blindness or visual impairments that preclude the identification of on-screen visuals * individuals with auditory impairments preventing the recognition of sounds through headphones.
Where this trial is running
Taipei, Neihu Distinct
- Tri-Service General Hospital — Taipei, Neihu Distinct, Taiwan (Recruiting)
Study contacts
- Study coordinator: Hsin-Yi Lu
- Email: f8888877@gmail.com
- Phone: +886972221359
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.