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

Mayo Clinic24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Adjustment Disorder Anxiety Disorder Depression

Interventions

Questionnaire AdministrationOTHER

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

Virtual Reality (VR) InterventionOTHER

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

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

Change in anxiety

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.

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

Change in depression

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).

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

Change in fatigue

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.

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

Change in overall quality of life

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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts