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NCT Number: NCT07221409

Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment

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.

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Key information

Conditions

Adjustment Disorder Adjustment Disorders Anxiety Disorder Anxiety Disorders Behavior Behavioral Symptoms Cancer Depression Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Mental Disorders Neoplasms Trauma and Stressor Related Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

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

Virtual Reality (VR) Intervention

Other

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.

Other names: VR Intervention, Virtual Technology, VR Headset

Primary outcomes

  1. 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.

  2. 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

  3. 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

  1. Change in anxiety

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

    Assessed using the Patient Reported Outcome Measurement Information System (PROMIS) Cancer Bank v1.0 - Anxiety scale, which is specifically designed to measure anxiety in cancer patients. The scale consists of 22 questions related to anxiety symptoms over the past 7 days. Questions are answered on a 5-point scale (Never, Rarely, Sometimes, Often, Never). Higher scores reflect greater levels of anxiety.

  2. Change in depression

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

    Assessed using the PROMIS Cancer Bank v1.0 - Depression scale, which measures depressive symptoms in individuals with cancer through self-reported questions. The scale consists of 30 questions related to emotional distress over the past 7 days. Questions are answered on a 5-point scale (Never, Rarely, Sometimes, Often, Never). Higher scores indicate greater emotional distress (depression).

  3. Change in fatigue

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

    Assessed using the PROMIS Cancer Bank v1.0 - Fatigue scale, which measures experience of fatigue (frequency, duration, intensity) over the past 7 days and its impact on physical, mental, and social activities. The scale consists of 54 questions answered on a 5-point scale such as Not at all, A little bit, Somewhat, Quite a bit, Very much or Never, Rarely, Sometimes, Often, Always. Higher scores indicate greater fatigue.

  4. Change in overall quality of life

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

    Assessed via Uniscale questionnaire, which consists of a single question assessing overall quality of life during the past week. The question is answered on a 10-point Likert scale where 0=As bad as it cand be and 10=As good as it can be.

Study contacts

Contact information is provided by the study sponsor or research team.

Telly Coney

CONTACT

[email protected]

904-953-3725

Wendi Lehman

CONTACT

[email protected]

904-953-8742

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 27, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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