Breast CancerNCT06541587
Smart VR Mindfulness for Breast Cancer: Integrating Biofeedback and Evaluating Chemotherapy Effectiveness
A study testing mindfulness based virtual reality and mindfulness based audio practice in people with Breast Cancer and Chemotherapy, run by Hsin Yi Lu at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy, Virtual Reality
- What is being tested?
- mindfulness based virtual reality and mindfulness based audio practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, Neihu Distinct, 114
Tri-Service General Hospital, +886 287923311 ext. 17763, tsghirb@ndmctsgh.edu.tw
Hsin-Yi Lu, +886 972221359, f8888877@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- mindfulness based virtual reality, mindfulness based audio practice
- Keywords
- breast cancer, Chemotherapy, Virtual Reality, Mindfulness
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness based virtual realityBehavioural
mindfulness based virtual reality
mindfulness based audio practiceBehavioural
mindfulness based audio practice
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based virtual reality | Experimental | 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. Receives: Behavioral: mindfulness based virtual reality |
| mindfulness based audio practice | Active comparator | 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. Receives: Behavioral: mindfulness based audio practice |
| control | No intervention | routine chemotherapy care |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress perception
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 (5)
heart rate variability
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Mar 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hsin Yi Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hsin Yi Lu, Tri-Service General Hospital (TSGH)
- Investigators
- Hsueh-Hsing Pan, Study chair, Tri-Service General Hospital, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541587
- Sponsor's protocol ID
- B202405004
- Status last verified
- Aug 2024
- First submitted
- 5 Jan 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Virtual Reality Mindfulness System for Breast Cancer Chemotherapy: Integrating Stress Reduction Combined Multimodal Biofeedback and Clinical Effectiveness Evaluation
- ClinicalTrials.gov ID
- NCT06541587
- Acronym / sponsor ID
- B202405004
- Conditions
- Breast Cancer, Chemotherapy, Virtual Reality, Mindfulness
- Keywords
- breast cancer, Chemotherapy, Virtual Reality, Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hsin Yi LuUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based virtual reality | Experimental | Behavioral: mindfulness based virtual realityIn 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. |
| mindfulness based audio practice | Active comparator | Behavioral: mindfulness based audio practiceIn 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. |
| control | No intervention | –routine chemotherapy care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness based virtual realitymindfulness based virtual reality | Behavioural | mindfulness-based virtual reality |
| mindfulness based audio practicemindfulness based audio practice | Behavioural | mindfulness based audio practice |
Primary outcome
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.
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.
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsueh-Hsing Pan study chair
Tri-Service General Hospital, National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness based virtual reality and mindfulness based audio practice in people with Breast Cancer and Chemotherapy, run by Hsin Yi Lu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Yi Lu (+886972221359, f8888877@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.