NCT07426913

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
May 2026Feb 2027

First Submitted

Initial submission to the registry

February 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

February 16, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

virtual realitybreast cancerantracyclinestrastuzumabVCUVirginia Commonwealth University

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Physical Activity

    Baseline and 4 weeks post-intervention

  • Sleep Quality

    Baseline and 4 weeks post-intervention

  • Tobacco Use

    Baseline and 4 weeks post-intervention

  • Intent to Change Behavior

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

Study Arms (1)

Virtual Reality Group

EXPERIMENTAL

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

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.

Virtual Reality Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Arnethea Sutton, Ph.D

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnethea Sutton, Ph.D

CONTACT

Victoria Williams

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 23, 2026

Study Start

May 20, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations