NCT06541587 Smart VR Mindfulness for Breast Cancer: Integrating Biofeedback and Evaluating Chemotherapy Effectiveness
| NCT ID | NCT06541587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hsin Yi Lu |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-03-01 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Breast cancer patients undergoing chemotherapy often face significant physical and emotional symptoms, with stress contributing to symptom severity. This study investigates the effectiveness of a mindfulness-based virtual reality (VR) intervention in reducing stress and symptom severity. A total of 60 participants will be stratified and randomized into three groups: mindfulness-based VR, mindfulness-based audio, and control. Data will be analyzed using generalized estimating equations and machine learning. The goal is to improve understanding and quality of care for cancer patients by evaluating the potential benefits of mindfulness-based VR interventions.
Eligibility 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.
Contact & Investigator
Hsueh-Hsing Pan
STUDY CHAIR
Tri-Service General Hospital, National Defense Medical Center
Frequently Asked Questions
Who can join the NCT06541587 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06541587 currently recruiting?
Yes, NCT06541587 is actively recruiting participants. Contact the research team at f8888877@gmail.com for enrollment information.
Where is the NCT06541587 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06541587 clinical trial?
NCT06541587 is sponsored by Hsin Yi Lu. The principal investigator is Hsueh-Hsing Pan at Tri-Service General Hospital, National Defense Medical Center. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.