Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Pilot Study to Assess Safety, Tolerability and Efficacy of Virtual Reality in Cancer Patients
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
September 29, 2025
CompletedStudy Start
First participant enrolled
October 8, 2025
CompletedFirst Posted
Study publicly available on registry
October 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 8, 2027
April 2, 2026
March 1, 2026
2 years
September 29, 2025
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Successfully complete the virtual reality (VR) intervention (Feasibility)
Feasibility of VR will be assessed by the proportion of participants who successfully complete the intervention.
Baseline
Absence of major issues during administration (Feasibility)
Feasibility of VR will be evaluated by the absence of (low/no recorded incidence of) major technical or usability issues during administration
Baseline
Acceptability
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.
Baseline
Secondary Outcomes (4)
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)
Study Arms (1)
Virtual Reality (VR) Headset Intervention
EXPERIMENTALParticipants will undergo a single VR session to assess feasibility, tolerability, and changes in anxiety, depression, and fatigue.
Interventions
Participants will complete pre- and post-intervention questionnaires to assess symptoms of anxiety, depression, and fatigue.
Participants will engage in a single-session immersive Virtual Reality (VR) experience lasting approximately 20-30 minutes. The VR content will include calming, guided experiences such as nature scenes, meditation, or breathing exercises designed to promote relaxation and reduce psychological distress. The intervention will be administered in a clinical setting.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan C. Cardenas Rosales, MD
Mayo Clinic
Central Study Contacts
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
September 29, 2025
First Posted
October 27, 2025
Study Start
October 8, 2025
Primary Completion (Estimated)
October 8, 2027
Study Completion (Estimated)
October 8, 2027
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share