Anthracycline Related Cardiotoxicity in Breast Cancer, Breast Cancer, Trastuzumab, Virtual Reality
Conditions
Keywords
virtual reality, breast cancer, antracyclines, trastuzumab, VCU, Virginia Commonwealth University
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).
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
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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CTRCD Knowledge | Baseline, within 2 days post-Intervention, and 4 weeks post-intervention | 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). |
| Usability | Within 2 days post-Intervention | 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). |
| Acceptability | Within 2 days post-Intervention | 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). |
| User Satisfaction | Within 2 days post-Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | Baseline and 4 weeks post-intervention | 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. |
| Sleep Quality | Baseline and 4 weeks post-intervention | 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). |
| Tobacco Use | Baseline and 4 weeks post-intervention | 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. |
| Intent to Change Behavior | Baseline, within 2 days post-Intervention, and 4 weeks post-intervention | 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. |
Countries
United States
Contacts
CONTACTArnethea Sutton, Ph.D
CONTACTVictoria Williams
PRINCIPAL_INVESTIGATORArnethea Sutton, Ph.D
Virginia Commonwealth University
Outcome results
None listed