Breast CancerNCT07426913
Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab
A study testing Cardiovascular Health Education and Gaming through Virtual Reality in people with Breast Cancer and Anthracycline Related Cardiotoxicity in Breast Cancer, run by Virginia Commonwealth University at 3 sites in United States.
Trial summary
The main goal of this study is to test a virtual reality (VR) program, Survivors' Virtual Reality Survivorship Experience (SurviVRSE), designed to help Breast Cancer survivors (n=30) learn about heart health. The aims are to test the usability, feasibility, and acceptability o the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Virtual Reality
- What is being tested?
- Cardiovascular Health Education and Gaming through Virtual Reality
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 May 2026to 28 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older
- Able to speak and read in English
- Actively receiving Trastuzumab or an anthracycline-based treatment
- Currently receiving immunotherapy. This includes pembrolizumab and atezolizumab.
- Diagnosed with stages 0-III Breast Cancer
Who cannot join
- History of prior Breast Cancer diagnosis (i.e., not their first breast cancer diagnosis)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Adult Outpatient Pavilion
Richmond, Virginia, 23220
Victoria Williams, 8048277363, williamsv4@vcu.edu
- Recruiting
Cellular Immunotherapies and Transplant Department
Richmond, Virginia, 23220
Victoria Williams, 8048277363, williamsv4@vcu.edu
- Recruiting
VCU Health at Stony Point
Richmond, Virginia, 23223
Victoria Williams, 8048277363, williamsv4@vcu.edu
About this study
Official title: Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab - Phase 2
The main goal of this study is to test a virtual reality (VR) program, Survivors' Virtual Reality Survivorship Experience (SurviVRSE), designed to help Breast Cancer survivors (n=30) learn about heart health. The aims are to test the usability, feasibility, and acceptability o the intervention. Additionally, follow-up assessments will examine changes in women's cancer therapy related cardiac dysfunction knowledge and heart healthy behaviors (e.g., physical activity).
Read the detailed description
The long-term goal is to develop multilevel interventions and inform practice guidelines that mitigate the cancer therapy related cardiac dysfunction (CTRCD) burden in breast cancer survivors. The overall objective of this of this application is to develop and test a virtual reality (VR) intervention to educate breast survivors about their risk of developing CTRCD following treatment and about behavioral approaches to potentially mitigate risk. VR is emerging as an effective method for improving health-related knowledge, specifically in the context of CTRCD and cardiovascular risk factors, by allowing users to actively engage in medical content. Moreover, content can be tailored to groups of people and to each individual user. The central hypothesis is that the VR intervention will increase women's knowledge of the potential cardiovascular side effects of their treatment and of behavior modifications that may protect their hearts. This hypothesis was formulated preliminary data showing that survivors who received potentially cardiotoxic treatment recommended more information about their treatment and the importance of physical activity early in their primary treatment journey. The rationale for the proposed study is that although VR is gaining popularity as an educational tool, there remains a significant knowledge gap in its utilization in the context of cancer survivorship and implantation in clinic settings.
- Conditions
- Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Virtual Reality, Trastuzumab
- Being tested
- Cardiovascular Health Education and Gaming through Virtual Reality
- Keywords
- virtual reality, breast cancer, antracyclines, trastuzumab, VCU, Virginia Commonwealth University
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Health Education and Gaming through Virtual RealityBehavioural
Prior to engaging the intervention, participants will complete a baseline survey. The virtual reality intervention will be delivered at one infusion treatment. Participants will complete all education modules and affiliated games. The education focuses on potentially cardiotoxic treatments (e.g., anthracyclines), ways to identify cancer treatment related cardiovascular dysfunction, and heart healthy behaviors that survivors can initiate during survivorship. Following the intervention participants will complete a survey similar to the baseline survey. One-month following the intervention participants will complete one final survey.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Individuals in this arm will receive access to the virtual reality in cardiovascular health education and gaming intervention Receives: Behavioral: Cardiovascular Health Education and Gaming through Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTRCD Knowledge
Change in knowledge of CTRCD and in measures of improving cardiovascular health. This investigator-developed true/false knowledge survey consists of 10 items that directly assess knowledge learned in SurviVRSE. Scoring this scale will consist of summing up the total items that were answered correctly (range = 0-10; 0 = no knowledge and 10=high knowledge).
Measured: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention
Usability
Usability will be assessed using the Virtual Reality System Usability Questionnaire. This 10-item measure includes prompts such as "I think I would like to use this system frequently" and "I thought the system was easy to use." Women will respond to the items using a 5-point Likert scale (1= strongly disagree and 5= strongly agree). Scores will be totaled (with some items requiring reverse-coding).
Measured: Within 2 days post-Intervention
Acceptability
Acceptability will be assessed using the User Experience Questionnaire, a validated 8-item 7-point Likert scale survey that measures pragmatic and hedonic qualities of SurviVRSE (e.g., obstructive/supportive, complicated/easy). The UEC developers provide an Excel spreadsheet to analyze data collected from the tool. https://www.ueq-online.org/. The range of the scales is between -3 (horribly bad) to +3 (extremely good).
Measured: Within 2 days post-Intervention
User Satisfaction
SurviVRSE satisfaction and engagement will be assessed using an adapted 6-item 5-point Likert scale survey (1=strongly disagree and 5=strongly agree). Items include "I could engage SurviVRSE," I would recommend SurviVRSE to another survivor," and "I liked the music." To evaluate satisfaction, the six items will be totaled. Scores will range from 6-30 with higher scores indicating greater satisfaction.
Measured: Within 2 days post-Intervention
Secondary outcomes (4)
Physical Activity
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). The 7-item scale assesses sedentary behavior, and moderate and vigorous physical activity by asking respondents if they participate in various forms of physical activity and, if so, how many hours and minutes/day. Scores will be reported as Metabolic Equivalent of Task (MET) minutes a week. Higher MET minutes equate to greater energy expenditure. High >= 1500 MET minutes a week; Moderate >=600 MET minutes a week; Low: not meeting criteria for moderate or high.
Measured: Baseline and 4 weeks post-intervention
Sleep Quality
The Insomnia Severity Index will be used to assess sleep quality. This 7-item scale prompts respondents to consider the past 2 weeks when responding to items about falling asleep, staying asleep, and waking up to early in addition to the perceived impact their sleep has on their daily lives. The scale consists of likert scales such as none to very (0=none and 4=very); very satisfied to very dissatisfied (0=very satisfied and 4=very dissatisfied); and not at all to very much (0=not at all and 4=very much). The total score of the 7 items determines insomnia severity (0-7 = no clinically significant insomnia to 22-28 = clinical insomnia).
Measured: Baseline and 4 weeks post-intervention
Tobacco Use
The Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire for Tobacco use will be used to assess cigarette, snuff and other forms of tobacco (4 items). Responses include yes/no for some items (e.g., Have you smoked at least 100 cigarettes in your entire life) or Likert (1=every day to 3 not at all) for other items (e.g., Do you now smoke cigarettes every day, some days, or not at all). Each item is assessed individually.
Measured: Baseline and 4 weeks post-intervention
Intent to Change Behavior
This 3-item scale, developed by the investigative team, assesses an individual's intent to change the following behaviors - physical activity, sleep, and tobacco use. Participants will respond to each item using a 5-point Likert scale (1= strongly disagree to 5 = strongly agree). Higher scores will indicate greater intent to change the behavior, and each item will be scored individually.
Measured: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start20 May 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion28 Sep 2027 (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.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnethea Sutton, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426913
- Sponsor's protocol ID
- MCC-25-22806
- Other IDs
- HM300000618
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab - Phase 2
- ClinicalTrials.gov ID
- NCT07426913
- Acronym / sponsor ID
- MCC-25-22806
- Conditions
- Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Virtual Reality, Trastuzumab
- Keywords
- virtual reality, breast cancer, antracyclines, trastuzumab, VCU, Virginia Commonwealth University
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 28 Sep 2027 (estimated)
- First posted
- 23 Feb 2026 (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.
The main goal of this study is to test a virtual reality (VR) program, Survivors' Virtual Reality Survivorship Experience (SurviVRSE), designed to help Breast Cancer survivors (n=30) learn about heart health. The aims are to test the usability, feasibility, and acceptability o the intervention. Additionally, follow-up assessments will examine changes in women's cancer therapy related cardiac dysfunction knowledge and heart healthy behaviors (e.g., physical activity).
Detailed description
The long-term goal is to develop multilevel interventions and inform practice guidelines that mitigate the cancer therapy related cardiac dysfunction (CTRCD) burden in breast cancer survivors. The overall objective of this of this application is to develop and test a virtual reality (VR) intervention to educate breast survivors about their risk of developing CTRCD following treatment and about behavioral approaches to potentially mitigate risk. VR is emerging as an effective method for improving health-related knowledge, specifically in the context of CTRCD and cardiovascular risk factors, by allowing users to actively engage in medical content. Moreover, content can be tailored to groups of people and to each individual user. The central hypothesis is that the VR intervention will increase women's knowledge of the potential cardiovascular side effects of their treatment and of behavior modifications that may protect their hearts. This hypothesis was formulated preliminary data showing that survivors who received potentially cardiotoxic treatment recommended more information about their treatment and the importance of physical activity early in their primary treatment journey. The rationale for the proposed study is that although VR is gaining popularity as an educational tool, there remains a significant knowledge gap in its utilization in the context of cancer survivorship and implantation in clinic settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Cardiovascular Health Education and Gaming through Virtual RealityIndividuals in this arm will receive access to the virtual reality in cardiovascular health education and gaming intervention |
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)
- 18 years of age or older
- Able to speak and read in English
- Actively receiving Trastuzumab or an anthracycline-based treatment
- Currently receiving immunotherapy. This includes pembrolizumab and atezolizumab.
- Diagnosed with stages 0-III Breast Cancer
Key exclusion criteria (1 listed)
- History of prior Breast Cancer diagnosis (i.e., not their first breast cancer diagnosis)
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 |
|---|---|---|
| Cardiovascular Health Education and Gaming through Virtual RealityPrior to engaging the intervention, participants will complete a baseline survey. The virtual reality intervention will be delivered at one infusion treatment. Participants will complete all education modules and affiliated games. The education focuses on potentially cardiotoxic treatments (e.g., anthracyclines), ways to identify cancer treatment related cardiovascular dysfunction, and heart healthy behaviors that survivors can initiate during survivorship. Following the intervention participants will complete a survey similar to the baseline survey. One-month following the intervention participants will complete one final survey. | Behavioural | Virtual Reality Group |
Primary outcome
CTRCD Knowledge
Time frame: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention
Change in knowledge of CTRCD and in measures of improving cardiovascular health. This investigator-developed true/false knowledge survey consists of 10 items that directly assess knowledge learned in SurviVRSE. Scoring this scale will consist of summing up the total items that were answered correctly (range = 0-10; 0 = no knowledge and 10=high knowledge).
Usability
Time frame: Within 2 days post-Intervention
Usability will be assessed using the Virtual Reality System Usability Questionnaire. This 10-item measure includes prompts such as "I think I would like to use this system frequently" and "I thought the system was easy to use." Women will respond to the items using a 5-point Likert scale (1= strongly disagree and 5= strongly agree). Scores will be totaled (with some items requiring reverse-coding).
Acceptability
Time frame: Within 2 days post-Intervention
Acceptability will be assessed using the User Experience Questionnaire, a validated 8-item 7-point Likert scale survey that measures pragmatic and hedonic qualities of SurviVRSE (e.g., obstructive/supportive, complicated/easy). The UEC developers provide an Excel spreadsheet to analyze data collected from the tool. https://www.ueq-online.org/. The range of the scales is between -3 (horribly bad) to +3 (extremely good).
User Satisfaction
Time frame: Within 2 days post-Intervention
SurviVRSE satisfaction and engagement will be assessed using an adapted 6-item 5-point Likert scale survey (1=strongly disagree and 5=strongly agree). Items include "I could engage SurviVRSE," I would recommend SurviVRSE to another survivor," and "I liked the music." To evaluate satisfaction, the six items will be totaled. Scores will range from 6-30 with higher scores indicating greater satisfaction.
4 secondary outcomes
Physical Activity
Time frame: Baseline and 4 weeks post-intervention
Sleep Quality
Time frame: Baseline and 4 weeks post-intervention
Tobacco Use
Time frame: Baseline and 4 weeks post-intervention
Intent to Change Behavior
Time frame: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Arnethea Sutton, Ph.D principal investigator
Virginia Commonwealth University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular Health Education and Gaming through Virtual Reality in people with Breast Cancer and Anthracycline Related Cardiotoxicity in Breast Cancer, run by Virginia Commonwealth University at 3 sites in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnethea Sutton, Ph.D (8048277363, careslab@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTRCD Knowledge (time frame: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention). The study lists 4 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 22 Sep 2026.