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

Not Applicable

Recruiting

• Conditions: Adjustment Disorder; Anxiety Disorder; Depression; Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm; Cancer

• Registration Number: NCT07221409
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-29
• Status Verified: 2025-10
• Study Start: 2025-10-08
• Study First Submitted QC: 2025-10-23
• Study First Posted: 2025-10-27
• Last Update Submitted: 2025-10-27
• Last Update Posted: 2025-10-29
• Primary Completion: 2027-10-08
• Study Completion: 2027-10-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Successfully complete the virtual reality (VR) intervention (Feasibility)	Baseline	Feasibility of VR will be assessed by the proportion of participants who successfully complete the intervention.
Absence of major issues during administration (Feasibility)	Baseline	Feasibility of VR will be evaluated by the absence of (low/no recorded incidence of) major technical or usability issues during administration
Acceptability	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 Outcome Measures

Name	Time	Method
Change in anxiety	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.
Change in depression	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).
Change in fatigue	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.
Change in overall quality of life	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States