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

Trial Status: Active

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.

Inclusion Criteria

  • - 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

Maryland

Bethesda
National Institutes of Health Clinical Center
Status: ACTIVE
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937

Background

- Psychological distress is a common concern for patient across the cancer trajectory,

which has been associated with worse clinical outcomes in terms of quality of life,

adherence to treatment regimens, satisfaction with care, and poorer survival in past

research.

- Virtual reality (VR) has the potential to alleviate some of the negative aspects of

illness by allowing individuals to escape from their lives and experience more positive

thoughts and emotions, which can be accomplished using cardiac coherence breathing

techniques and distraction (both of which can improve psychological symptoms).

- Past VR research has shown promising improvements in anxiety, pain, distress and

distraction through use of immersive VR interventions, though there is scant evidence in

PBT populations, particularly in the time period surrounding their neuroimaging and

clinical appointments when distress and anxiety can be highest.

- Recent evidence has demonstrated that the COVID-19 pandemic and associated mitigation

procedures introduce additional stress for cancer patients, with higher levels of

anxiety, depression, loneliness, and financial toxicity being reported during this time.

- The purpose of this phase II clinical trial is to determine the feasibility of

implementing an immersive VR relaxation intervention in a PBT population and to assess

the efficacy of the intervention to improve psychological distress and anxiety at the

time of clinical evaluation. VR is an innovative delivery approach to teach our patients

validated breathing and mindfulness techniques that can improve their psychological

symptoms and their ability to self-manage these symptoms.

Objectives

-To assess the feasibility of implementing a VR relaxation intervention in a PBT population

at the time of clinical evaluation (i.e. eligibility, accrual, compliance, adverse device

effects, study completion, and participant satisfaction)

Eligibility

- PBT patients enrolled on the Natural History Study (NHS) trial in the Neuro-Oncology

Branch (NOB) (all tumor types and grades eligible)

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

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

self-report symptoms

- Active corticosteroid therapy is permissible

- Exclude patients without tissue diagnosis, recent cranial surgery (less than or equal to

2 weeks), scalp wound healing issues, or seizures within the last 6 weeks

- Participants have reported greater than or equal to 1 on distres item from MDASI-BT

prior to past clinic appointment

- Exclude patients who have a hypersensitivity to motion, severe nausea, or visual field

deficits that might interfere with VR experience

- Exclude patients with a current diagnosis of generalized anxiety disorder (GAD),

post-traumatic stress disorder (PTSD), claustrophobia, or panic disorder

Design

- This is a phase II feasibility clinical trial with a single arm experimental design. The

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

using telehealth.

- Study will include collection of self-reported PROs for distress, anxiety, mood

disturbance, symptom burden/interference, quality of life, cognitive function,

loneliness, and financial toxicity, as well as optional salivary stress biomarkers.

These measures will be collected at baseline and immediately after a brief VR relaxation

intervention to determine acute effects on distress, anxiety, and biological stress

measures. Repeat post-intervention assessments will be done approximately 1 week and 1

month following the initial intervention to determine sub-acute effects on distress and

anxiety, as well as impact on other symptoms and stress biomarkers. A semi-structured

qualitative interview will also be conducted 1 week after the initial intervention to

assess participant satisfaction with the intervention and how the pandemic has affected

their psychological symptoms.

- Descriptive statistics, T-tests, Wilcoxon rank sum tests, and multiple logistic

regression models will be used to evaluate the feasibility of the VR intervention.

Linear mixed models and effect size calculations will be used to evaluate the acute and

sub-acute effects of the VR intervention on self- reported PROs. Pearson or Spearman

correlations will be used to evaluate the relationship between the biological stress

measures and self-reported PROs.

- A total of 120 PBT patients will participate in this study.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
National Cancer Institute

Principal Investigator
Terri Sue Armstrong

  • Primary ID 200065
  • Secondary IDs NCI-2020-01753, 20-C-0065
  • Clinicaltrials.gov ID NCT04301089