Pilot Study to Assess Safety, Tolerability and Efficacy of Virtual Reality in Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Successfully complete the virtual reality (VR) intervention (Feasibility)
Study Overview
Brief Summary
This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden for cancer patients undergoing treatment. Virtual reality (VR) is a technology that allows users to experience and interact with three-dimensional, computer-generated environments that simulate the real world or imagined settings. The VR intervention consists of a preloaded with immersive environments designed to engage the senses through simulated sights and sounds. This may include a walk through of a serene forest, exploring vibrant coral reefs, swimming with dolphins, or standing at the base of a majestic waterfall. These environments are created to provide a relaxing and engaging experience. Completing the VR intervention may be a safe and effective way to improve quality of life, reduce anxiety, enhance focus, and promote healthy living for cancer patients undergoing treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of cancer
- •Age between 18 to 90 years
- •Undergoing in-patient chemotherapy, bone marrow transplant (BMT), chimeric antigen receptor (CAR)-t, & out-patient chemotherapy
Exclusion Criteria
- •History of bipolar disorder, major depression, bipolar disorder, anxiety disorder, post traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), psychotic disorder, schizophrenia, personality disorder, substance use disorder other than caffeine or tobacco. History of suicidal ideation or attempt
- •History of treatment resistant depression, psychiatric hospitalization, syncope, transient ischemic attack (TIA), stroke, epilepsy, electroconvulsive therapy, benign positional vertigo, Meniere's disease
Arms & Interventions
Virtual Reality (VR) Headset Intervention
Participants will undergo a single VR session to assess feasibility, tolerability, and changes in anxiety, depression, and fatigue.
Intervention: Questionnaire Administration (Other)
Virtual Reality (VR) Headset Intervention
Participants will undergo a single VR session to assess feasibility, tolerability, and changes in anxiety, depression, and fatigue.
Intervention: Virtual Reality (VR) Intervention (Other)
Outcomes
Primary Outcomes
Successfully complete the virtual reality (VR) intervention (Feasibility)
Time Frame: Baseline
Feasibility of VR will be assessed by the proportion of participants who successfully complete the intervention.
Absence of major issues during administration (Feasibility)
Time Frame: Baseline
Feasibility of VR will be evaluated by the absence of (low/no recorded incidence of) major technical or usability issues during administration
Acceptability
Time Frame: Baseline
Will be assessed via the Post-Study Exit Interview Questionnaire, a questionnaire developed specifically for this study. It consists of 17 questions. Eight questions relate to the VR experience (e.g., comfort of headset, control of actions in VR environment, understandability of instructions, technical issues). Five questions relate to symptoms (e.g., dizziness, nausea, headache) or discomfort experienced during and immediately following VR use. The remaining questions relate to helpfulness of intervention, improvement suggestions, other feedback, and interest in learning more about services and resources. Results will be analyzed descriptively.
Successfully complete the virtual reality (VR) intervention (Feasibility)
Time Frame: Baseline
Feasibility of VR will be assessed by the proportion of participants who successfully complete the intervention.
Absence of major issues during administration (Feasibility)
Time Frame: Baseline
Feasibility of VR will be evaluated by the absence of (low/no recorded incidence of) major technical or usability issues during administration
Acceptability
Time Frame: Baseline
Will be assessed via the Post-Study Exit Interview Questionnaire, a questionnaire developed specifically for this study. It consists of 17 questions. Eight questions relate to the VR experience (e.g., comfort of headset, control of actions in VR environment, understandability of instructions, technical issues). Five questions relate to symptoms (e.g., dizziness, nausea, headache) or discomfort experienced during and immediately following VR use. The remaining questions relate to helpfulness of intervention, improvement suggestions, other feedback, and interest in learning more about services and resources. Results will be analyzed descriptively.
Secondary Outcomes
- Change in anxiety(Baseline (pre- to post-intervention, approximately 1.5 hours))
- Change in depression(Baseline (pre- to post-intervention, approximately 1.5 hours))
- Change in fatigue(Baseline (pre- to post-intervention, approximately 1.5 hours))
- Change in overall quality of life(Baseline (pre- to post-intervention, approximately 1.5 hours))