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

Hsin Yi Lu

Status: Enrolling

Conditions: Breast Cancer; Chemotherapy; Mindfulness; Virtual Reality

Treatments: Behavioral: mindfulness based audio practice; Behavioral: mindfulness based virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06541587

B202405004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

mindfulness-based virtual reality

Experimental group

Description:

In addition to routine chemotherapy care, the intervention involves the use of a smart breast cancer chemotherapy mindfulness-based integrated virtual reality and multimodal physiological feedback training system module. This will be administered during each of the first to fifth inpatient chemotherapy sessions. The equipment operator, a researcher, will use the AI-Pico Neo 3 Pro headset, featuring a dual-eye resolution of 2880\*1600 pixels, a refresh rate of 90Hz, and a 110-degree field of view. The interpupillary distance, headset strap tightness, and volume will be adjusted according to the participant's comfort. The scenario content includes three shared scenes: beach, forest, and starry sky, from which participants can choose based on their preference. Each session will last 12 minutes and be conducted once. Participants will assume a semi-reclining position during the session. Monitoring will be conducted with the researcher assisting the participant on-site.

Treatment:

Behavioral: mindfulness based virtual reality

mindfulness based audio practice

Active Comparator group

Description:

In addition to routine chemotherapy care, the intervention includes mindfulness-based audio exercises. Participants will use over-ear headphones that play the same content as experimental group A, but without virtual reality. This will be administered during each of the first to fifth inpatient chemotherapy sessions. The equipment operator, a researcher, will use Sony over-ear headphones, adjusting the fit and volume according to the participant's comfort. The audio content includes three background sounds: beach, forest, and starry sky, from which participants can choose based on their preference. Each session will last 12 minutes and be conducted once. Participants will assume a semi-reclining position during the session. Monitoring will be conducted with the researcher assisting the participant on-site.

Treatment:

Behavioral: mindfulness based audio practice

control

No Intervention group

Description:

routine chemotherapy care