ClinicalTrials.gg
RecruitingNCT07426913Updated Sep 22, 2026

Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab

An interventional study of Cardiovascular Health Education and Gaming through Virtual Reality in Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer and Virtual Reality, sponsored by Virginia Commonwealth University. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 26 studies in Breast Neoplasms by Virginia Commonwealth University — 5 open to participants now, 8 under way, none of them phase 3. Breast Neoplasms · Virginia Commonwealth University.

Planned enrollment
15th of 23
30 · median 46
Started
2026
with 2 others
No phase
9 of 26
1 open now
Registered
24th of 26
by date

Among the 26 studies in Breast Neoplasms by Virginia Commonwealth University, this one is the 15th largest by planned enrollment of the 23 interventional ones that give a count, is one of 3 that started in 2026, is one of 9 with no phase, and was the 24th registered.

Breast Neoplasms

14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

5 of the 26 studies in Breast Neoplasms by Virginia Commonwealth University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Breast Cancer
  • Anthracycline Related Cardiotoxicity in Breast Cancer
  • Virtual Reality
  • Trastuzumab

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Keywords

  • virtual reality
  • breast cancer
  • antracyclines
  • trastuzumab
  • VCU
  • Virginia Commonwealth University
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

- History of prior Breast Cancer diagnosis (i.e., not their first breast cancer diagnosis)

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Virtual Reality Group

    Individuals in this arm will receive access to the virtual reality in cardiovascular health education and gaming intervention

    Behavioral: Cardiovascular Health Education and Gaming through Virtual Reality

Interventions

  • BehavioralCardiovascular Health Education and Gaming through Virtual Reality

    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.

This study also gives Trastuzumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention

  2. 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).

    Time frame: Within 2 days post-Intervention

  3. 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).

    Time frame: Within 2 days post-Intervention

  4. 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.

    Time frame: Within 2 days post-Intervention

Secondary outcomes

  1. 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.

    Time frame: Baseline and 4 weeks post-intervention

  2. 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).

    Time frame: Baseline and 4 weeks post-intervention

  3. 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.

    Time frame: Baseline and 4 weeks post-intervention

  4. 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.

    Time frame: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention

07

Study locations

3 of 3 sites recruiting
  • Adult Outpatient Pavilion
    Richmond, Virginia 23220, United States
    Recruiting
  • Cellular Immunotherapies and Transplant Department
    Richmond, Virginia 23220, United States
    Recruiting
  • VCU Health at Stony Point
    Richmond, Virginia 23223, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Jul 2027, 14 months after the start.

Of 2,663 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 14 months is below that.

Counting every sponsor, half of 2,773 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2026
First posted
Feb 23, 2026
StartActual
May 20, 2026
Primary completionEst.
Jul 30, 2027
CompletionEst.
Sep 28, 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07426913
Responsible party
Sponsor
First posted
Feb 23, 2026
Start date
May 20, 2026
Primary completion
Jul 30, 2027 (estimated)
Completion
Sep 28, 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Arnethea Sutton, Ph.D
Contact
careslab@vcu.edu
8048277363
Victoria Williams
Contact
williamsv4@vcu.edu
8048277363
Arnethea Sutton, Ph.D
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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