Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiovascular Health Education and Gaming through Virtual Reality.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Virtual Reality, Trastuzumab. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab - Phase 2
Overview
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.
Interventions
- 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 participant
Primary outcome measures
- CTRCD Knowledge [Time frame: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention]
- Usability [Time frame: Within 2 days post-Intervention]
- Acceptability [Time frame: Within 2 days post-Intervention]
- User Satisfaction [Time frame: Within 2 days post-Intervention]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
\- History of prior Breast Cancer diagnosis (i.e., not their first breast cancer diagnosis)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- Adult Outpatient Pavilion — Richmond
- Cellular Immunotherapies and Transplant Department — Richmond
- VCU Health at Stony Point — Richmond
Identifiers
NCT: NCT07426913 · MCC-25-22806 · HM300000618