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Protocol Details

A Phase II Feasibility Trial Using Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-C-0065

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Adults who are or may become unable to consent;
Non-English Speaking;
Children

Special Instructions

Currently Not Provided

Keywords

Therapeutic VR Platform;
Scanxiety;
Brain Cancer;
Brain Tumors

Recruitment Keyword(s)

None

Condition(s)

Anxiety

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: Pico G2 4K Headset with Applied VR software

Supporting Site

National Cancer Institute

Background:

Distress, anxiety, and other psychological disorders may be more common in people with primary brain tumors (PBTs). PBTs can affect their symptoms, quality of life, and their tolerance of cancer treatments. Researchers want to learn if virtual reality (VR) technology can help reduce stress and improve mood. VR uses computer technology to make fake experiences and environments that look real. This allows people to escape from their lives and experience more positive thoughts and emotions.

Objective:

To learn if it is feasible to use a VR relaxation intervention in people with PBTs.

Eligibility:

Adults 18 and older who have a brain tumor and have recently reported psychological distress during their participation in the Natural History Study (NHS), protocol #16C0151

Design:

The VR intervention and all patient-reported outcome measures (PROs) will be done remotely using telehealth.

Participants will be mailed a VR headset. This headset looks like a thick pair of goggles that is worn over the eyes. Participants will view computer-generated environments on this VR headset.

Participants will fill out symptoms questionnaires at 4 different times points during participation in this study, including questionnaires for the NHS as well as 4 questionnaires unique to this study. There are also optional saliva samples collected at these timepoints. The 4 timepoints are:

-Before the VR intervention

-After the VR intervention

-1 week later

-4 weeks later

Participants will also have a phone interview 1 week after the initial VR interevention, which will last 10 to 15 minutes.

Participation lasts 4 to 6 weeks.

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Eligibility

INCLUSION CRITERIA:

-PBT patients enrolled on the Natural History Study (NHS) trial (16C0151) in the Neuro-Oncology Branch (NOB) who have an upcoming scan & clinical appointment

-Participants can be newly diagnosed, receiving active treatment, or on surveillance

-Concurrent enrollment in other NOB trials is permissible

-Adults (greater than or equal to 18 years of age) who are English-speaking

-Participants must be able to reliably self-report symptoms, based on clinician assessment

-Participants report greater than or equal to 1 on distress item from MDASI-BT prior to clinic appointment

-Active corticosteroid therapy is permissible

-Ability of subject to understand and the willingness to sign a written informed consent document

EXCLUSION CRITERIA:

-Participants who do not have a tissue diagnosis (no past surgery or biopsy to confirm diagnosis)

-Cranial surgery less than or equal to 2 weeks prior to initiation of study intervention

-Scalp wound healing issues that might interfere with comfortable VR headset use

-Those who have epilepsy or have had a seizure in the last 6 weeks

-Participants with a current diagnosis of generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), claustrophobia, or panic disorder

-Participants who have a hypersensitivity to motion or severe nausea, which could make the VR experience uncomfortable

-Those with visual deficits that might interfere with the VR experience, including hemianopsia, diplopia, and agnosia based on their most recent clinical assessment


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Citations:

Lin L, Chiang HH, Acquaye AA, Vera-Bolanos E, Gilbert MR, Armstrong TS. Uncertainty, mood states, and symptom distress in patients with primary brain tumors: analysis of a conceptual model using structural equation modeling. Cancer. 2013 Aug 1;119(15):2796-806. doi: 10.1002/cncr.28121. Epub 2013 May 9.

Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.

Niki K, Okamoto Y, Maeda I, Mori I, Ishii R, Matsuda Y, Takagi T, Uejima E. A Novel Palliative Care Approach Using Virtual Reality for Improving Various Symptoms of Terminal Cancer Patients: A Preliminary Prospective, Multicenter Study. J Palliat Med. 2019 Jun;22(6):702-707. doi: 10.1089/jpm.2018.0527. Epub 2019 Jan 24.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Terri S. Armstrong, C.R.N.P.
National Cancer Institute (NCI)



NCI NOB Referral Group
National Cancer Institute (NCI)

(866) 251-9686
ncinobreferrals@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04301089

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