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

August 2, 2024 updated by: Hsin Yi Lu

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Neihu Distinct
      • Taipei, Neihu Distinct, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hsin-Yi Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: mindfulness-based virtual reality
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.
Behavioral: mindfulness based virtual reality
mindfulness based virtual reality
Active Comparator: mindfulness based audio practice
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.
Behavioral: mindfulness based audio practice
mindfulness based audio practice
No Intervention: control
routine chemotherapy care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
stress perception
Time Frame: 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)
The Revised Newly Diagnosed Breast Cancer Stress Scale (NDBCSS-R) will be used: This scale consists of 17 items, divided into four parts: Negative Perception (3 items), Threat (4 items), Unpredictability (5 items), and Facing Challenge (4 items). Scoring is based on a 4-point Likert scale, with 3 indicating strong agreement and 0 indicating disagreement. Higher scores indicate a greater level of perceived stress. Items 1, 3, 5, 11, 13, and 15 are reverse-scored.
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)
symptom severity
Time Frame: 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)
The Memorial Symptom Assessment Scale (MSAS) will be used: It consists of 32 items. First, participants indicate the presence or absence of symptoms. If symptoms are present, the frequency, severity, and distress of 24 symptoms, and the severity and distress of 8 symptoms, are evaluated. Frequency and severity are assessed using a 4-point scale, with 1 indicating rarely or mild and 4 indicating almost constantly or very severe. If there are no symptoms, the item is scored as 0. Distress is assessed using a 5-point scale, with 0 indicating not at all and 4 indicating very much.
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)
Mindfulness efficacy
Time Frame: 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)
The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) will be used: It consists of 10 items, rated on a 4-point scale, with 1 indicating almost never and 4 indicating almost always. Higher scores indicate a higher level of mindfulness.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
heart rate variability
Time Frame: 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)
The three-lead electrocardiography (ECG) from the Thought Technology five-channel biofeedback system kit will be used as the measurement tool. Using the NeuroKit2 package in Python, we aim to extract R-peaks from time-series data. Initially, we apply a 60 Hz notch filter to remove powerline noise, followed by a bandpass filter with a frequency range of 0.05 to 100 Hz. To enhance the QRS complex and make the R-peaks more prominent within the signal, we use a dynamic threshold setting based on the signal amplitude from the preceding 15 seconds. Subsequently, we detect the peaks, verify, and correct them. Finally, we calculate the HRV features.
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)
Respiration pattern variability
Time Frame: 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)
Respiration belts from the Thought Technology five-channel biofeedback system kit will be used to measure changes in chest volume during breathing. Using the NeuroKit2 package in Python, we employ Fast Fourier Transform (FFT) to convert the time-series data to the frequency domain. We set the frequency range to 0.2 to 0.33 Hz to correspond to a normal average breathing rate of 12 to 20 breaths per minute, thereby removing irrelevant noise. The difference method is used to calculate and establish the starting points of inhalation and exhalation, allowing for the calculation of breathing rate and relative breathing depth. A moving average method is then applied to provide a stable mean representation of the breathing rate, eliminating transient anomalies. These processed data are subsequently used to calculate RRV features.
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)
Electroencephalogram
Time Frame: 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)
The OpenBCI Ganglion Board will serve as the development platform, with the chip and wet electrodes integrated into a virtual reality headset for user convenience. Bluetooth connectivity will interface with the Pico headset, transmitting EEG signals to the software. A four-channel EEG setup, with electrodes placed according to the international 10-20 system, will be employed. Using the NeuroKit2 package in Python, we preprocess EEG data by initially filtering to remove 60 Hz noise and retain 2 to 30 Hz signals. We then convert the signals to the time-frequency domain using Morlet Wavelet, capturing features across different frequency bands. The power spectral density of each channel is segmented into δ, θ, α, β, and γ bands, and the average power in each band is calculated to analyze and compare brainwave activity intensity.
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)
Electrodermal Activity
Time Frame: 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)
Skin conductance monitoring electrodes from the Thought Technology five-channel biofeedback system kit will be used. Using the BioSPPy package in Python, we first apply a filter for noise reduction. Then, we detect peaks and extract features.
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)
Salivary cortisol concentration
Time Frame: 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)
The enzyme-linked immunosorbent assay (ELISA) will be used for detection. This method is based on the specific binding of antibodies to antigens, combined with a chromogenic substrate reaction. The color intensity is used to quantify the concentration of the specific target analyte in the sample.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hsin Yi Lu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hsueh-Hsing Pan, Tri-Service General Hospital, National Defense Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B202405004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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