Clinical trial NCT06541587: Smart VR Mindfulness for Breast Cancer: Integrating Biofeedback and Evaluating Chemotherapy Effectiveness
Official title: Smart Virtual Reality Mindfulness System for Breast Cancer Chemotherapy: Integrating Stress Reduction Combined Multimodal Biofeedback and Clinical Effectiveness Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Chemotherapy
Virtual Reality
Mindfulness
Keywords: breast cancer
Chemotherapy
Virtual Reality
Mindfulness
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: stress perception
timeFrame: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
measure: symptom severity
timeFrame: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
measure: Mindfulness efficacy
timeFrame: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
Secondary outcomes:
measure: heart rate variability
timeFrame: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
measure: Respiration pattern variability
timeFrame: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
measure: Electroencephalogram
timeFrame: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
measure: Electrodermal Activity
timeFrame: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
measure: Salivary cortisol concentration
timeFrame: Pre- and post-intervention assessments will be conducted from the first inpatient chemotherapy session to the fifth inpatient chemotherapy session (through study completion, an average of 15 weeks to 20 weeks)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Neihu Distinct
Study officials:
affiliation: Tri-Service General Hospital, National Defense Medical Center
name: Hsueh-Hsing Pan
role: STUDY_CHAIR
References: