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Pilot Study to Assess Safety, Tolerability and Efficacy of Virtual Reality in Cancer Patients

NCT ID: NCT07221409Sponsor: Mayo ClinicLast updated: 2026-04-02

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.

Arms & interventions

  • OtherQuestionnaire Administration

    Participants will complete pre- and post-intervention questionnaires to assess symptoms of anxiety, depression, and fatigue.

  • OtherVirtual Reality (VR) Intervention

    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.

Outcome measures

Primary

  • Successfully complete the virtual reality (VR) intervention (Feasibility)

    Feasibility of VR will be assessed by the proportion of participants who successfully complete the intervention.

    Time frame: 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

    Time frame: 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.

    Time frame: Baseline

Secondary

  • Change in anxiety

    Time frame: Baseline (pre- to post-intervention, approximately 1.5 hours)

  • Change in depression

    Time frame: Baseline (pre- to post-intervention, approximately 1.5 hours)

  • Change in fatigue

    Time frame: Baseline (pre- to post-intervention, approximately 1.5 hours)

  • Change in overall quality of life

    Time frame: Baseline (pre- to post-intervention, approximately 1.5 hours)

Eligibility criteria

Sex: AllAge: 18 Years to 90 YearsHealthy 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

Study locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

Recruiting
Wendi Lehman · Contact
Juan C. Cardenas Rosales, MD · Principal Investigator
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment | Cancerify