NCT06541587

Smart VR Mindfulness for Breast Cancer: Integrating Biofeedback and Evaluating Chemotherapy Effectiveness

Smart Virtual Reality Mindfulness System for Breast Cancer Chemotherapy: Integrating Stress Reduction Combined Multimodal Biofeedback and Clinical Effectiveness Evaluation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hsin Yi Lu · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: Breast cancer patients undergoing chemotherapy commonly experience physical and emotional symptoms, with approximately 90 percent of patients being affected. Perceived stress is one of the related factors that can contribute to symptom severity. Inadequate control of symptoms can have significant negative consequences on patient's quality of life, treatment adherence, disease prognosis, and increase the number of doctor visits, and overall treatment outcomes. The application of virtual reality in improving symptoms and perceived stress in breast cancer patients undergoing chemotherapy is an area of ongoing research, and the findings from existing studies have been inconsistent. Additionally, the incorporation of mindfulness techniques within VR interventions for this specific population has been limited. Objective: This study aims to explore the effectiveness of mindfulness-based virtual reality on the stress perception and symptom severity of breast cancer patients undergoing chemotherapy. Methods: Stratified block randomization will be used to assign 20 patients each to the mindfulness based virtul reality group, the mindfulness based audio practice group, and the control group, totaling 60 participants. Data analysis will be conducted using the generalized estimating equation and machine learning. Expected results: To understand the effectiveness of mindfulness-based virtual reality on the stress perception and the symptoms severity of chemotherapy in breast cancer patients, in order to serve as a reference for improving the quality of care for cancer patients in the future.

Conditions

• Breast Cancer
• Chemotherapy
• Virtual Reality
• Mindfulness

Interventions

Type	Name	Description
BEHAVIORAL	mindfulness based virtual reality	mindfulness based virtual reality
BEHAVIORAL	mindfulness based audio practice	mindfulness based audio practice

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2024-08-07
• Last updated: 2024-08-07

Locations

1 site across 1 country: Taiwan