Adjustment DisorderNCT07221409
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
A study testing Questionnaire Administration and Virtual Reality (VR) Intervention in people with Adjustment Disorder and Anxiety Disorder, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adjustment Disorder, Anxiety Disorder, Depression
- What is being tested?
- Questionnaire Administration and Virtual Reality (VR) Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2025to 8 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Wendi Lehman, 904-953-8742, lehman.wendi@mayo.edu
Telly Coney, 904-953-3725, coney.telleso@mayo.edu
About this study
Official title: Pilot Study to Assess Safety, Tolerability and Efficacy of Virtual Reality in Cancer Patients
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.
- Conditions
- Adjustment Disorder, Anxiety Disorder, Depression, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Cancer
- Being tested
- Questionnaire Administration, Virtual Reality (VR) Intervention
- Keywords
- Virtual Reality Therapy, VR Therapy, Non-Pharmacologic Intervention, Cancer Supportive Care
- Medical subject headings
- Adjustment Disorders, Anxiety Disorders, Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Participants will complete pre- and post-intervention questionnaires to assess symptoms of anxiety, depression, and fatigue.
Virtual Reality (VR) InterventionOther
Also called VR Intervention, Virtual Technology, VR Headset
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Headset Intervention | Experimental | Participants will undergo a single VR session to assess feasibility, tolerability, and changes in anxiety, depression, and fatigue. Receives: Other: Questionnaire Administration; Other: Virtual Reality (VR) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successfully complete the virtual reality (VR) intervention (Feasibility)
Feasibility of VR will be assessed by the proportion of participants who successfully complete the intervention.
Measured: 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
Measured: 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.
Measured: Baseline
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline (pre- to post-intervention, approximately 1.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start8 Oct 2025
- Primary completion8 Oct 2027 (estimated)
- Study completion8 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjustment DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan C. Cardenas Rosales, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221409
- Sponsor's protocol ID
- 25-002609
- Other IDs
- NCI-2025-07303, 25-002609
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Safety, Tolerability and Efficacy of Virtual Reality in Cancer Patients
- ClinicalTrials.gov ID
- NCT07221409
- Acronym / sponsor ID
- 25-002609
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 8 Oct 2027 (estimated)
- Study completion
- 8 Oct 2027 (estimated)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Headset Intervention | Experimental | Other: Questionnaire Administration, Other: Virtual Reality (VR) InterventionParticipants will undergo a single VR session to assess feasibility, tolerability, and changes in anxiety, depression, and fatigue. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationParticipants will complete pre- and post-intervention questionnaires to assess symptoms of anxiety, depression, and fatigue. | Other | Virtual Reality (VR) Headset Intervention |
| Virtual Reality (VR) InterventionAlso: VR Intervention, Virtual Technology, VR HeadsetParticipants 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 | Virtual Reality (VR) Headset Intervention |
Primary outcome
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.
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
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan C. Cardenas Rosales, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Virtual Reality (VR) Intervention in people with Adjustment Disorder and Anxiety Disorder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendi Lehman (904-953-8742, lehman.wendi@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successfully complete the virtual reality (VR) intervention (Feasibility) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.