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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Virtual Reality; Anthracycline Related Cardiotoxicity in Breast Cancer; Trastuzumab
• Intervention / Treatment: Behavioral: Cardiovascular Health Education and Gaming through Virtual Reality

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnethea Sutton, Ph.D; Phone Number: 8048277363; Email: careslab@vcu.edu
• Study Contact Backup: Name: Victoria Williams; Phone Number: 8048277363; Email: williamsv4@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Recruiting
      • Adult Outpatient Pavilion
      • Contact: Victoria Williams; Phone Number: 804-827-7363; Email: williamsv4@vcu.edu
    • Richmond, Virginia, United States, 23220
      • Recruiting
      • Cellular Immunotherapies and Transplant Department
      • Contact: Victoria Williams; Phone Number: 804-827-7363; Email: williamsv4@vcu.edu
    • Richmond, Virginia, United States, 23223
      • Recruiting
      • VCU Health at Stony Point
      • Contact: Victoria Williams; Phone Number: 804-827-7363; Email: williamsv4@vcu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• Able to speak and read in English
• Actively receiving Trastuzumab or an anthracycline-based treatment
• Diagnosed with stages 0-III Breast Cancer

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	Within 2 days post-Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	Baseline, within 2 days post-Intervention, and 4 weeks post-intervention

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Arnethea Sutton, Ph.D, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; trastuzumab; virtual reality; antracyclines; VCU; Virginia Commonwealth University
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: MCC-25-22806; HM300000618 (Other Identifier: Virginia Commonwealth University)

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