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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorVirginia Commonwealth University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Cardiovascular Health Education and Gaming through Virtual Reality

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Virtual Reality GroupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

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