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RecruitingNCT07221409Updated Oct 26, 2026

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

An interventional study of Questionnaire Administration and Virtual Reality (VR) Intervention in Adjustment Disorder, Anxiety Disorder and Depression, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

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

Keywords

  • Virtual Reality Therapy
  • VR Therapy
  • Non-Pharmacologic Intervention
  • Cancer Supportive Care
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In context

Adjustment Disorders

63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.

This study's planned enrollment of 24 is below the median of 100 across 52 interventional studies indexed under Adjustment Disorders.

Browse Adjustment Disorders studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, (TIA), stroke, epilepsy, electroconvulsive therapy, benign positional vertigo, Meniere's disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Virtual Reality (VR) Headset Intervention

    Participants will undergo a single VR session to assess feasibility, tolerability, and changes in anxiety, depression, and fatigue.

    Other: Questionnaire Administration · Other: Virtual Reality (VR) Intervention

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.

    Also known as: VR Intervention, Virtual Technology, VR Headset

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What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. 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)

  2. 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)

  3. 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)

  4. 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)

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07221409
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Oct 27, 2025
Start date
Oct 8, 2025
Primary completion
Oct 8, 2027 (estimated)
Completion
Oct 8, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Wendi Lehman
Contact
lehman.wendi@mayo.edu
904-953-8742
Telly Coney
Contact
coney.telleso@mayo.edu
904-953-3725
Juan C. Cardenas Rosales, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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