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Trial record 4 of 12 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | brain cancer | United States | Start date from 01/06/2021 to 04/08/2021

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

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ClinicalTrials.gov Identifier: NCT04301089
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE March 6, 2020
First Posted Date  ICMJE March 9, 2020
Last Update Posted Date August 2, 2021
Actual Study Start Date  ICMJE March 18, 2021
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
Number of participants who complete the sessions and questionnaires [ Time Frame: End of Study ]
To describe the feasibility of implementing a VR intervention in a PBT population, including eligibility, accrual, compliance, adverse events, study completion, and participant satisfaction with the intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2021)
  • Measurement of mood disturbance [ Time Frame: End of Study ]
    To assess the effects of a VR intervention on self-reported mood disturbance (as measured by PROMIS -Anxiety & PROMIS -Depression Short Forms) and symptom burden and interference (as measured by the MD Anderson Symptom Inventory Brain Tumor [MDASI-BT])
  • Measurement of distress and anxiety [ Time Frame: End of Study ]
    To determine if the effects VR has on distress and anxiety are more pronounced in those with high distress (based on DT cut-off score of greater than or equal to 5) compared those with to low distress (based on DT scores of 0 4)
  • Measurement of Distress [ Time Frame: End of Study ]
    To assess the effects of a VR intervention on self-reported acute and subacute distress (as measured by the NCCN Distress Thermometer [DT]) and anxiety (as measured by the State Anxiety Inventory [STAI-6]) in PBT patients
  • Measurement and comparison of distress and anxiety on those on systemic corticosteroids [ Time Frame: End of Study ]
    To determine if the effects VR has on distress and anxiety are more pronounced in those individuals not on systemic corticosteroids (CS) compared to those who are
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • Measurement of Distress [ Time Frame: End of Study ]
    To assess the effects of a VR intervention on self-reported acute and subacute distress (as measured by the NCCN Distress Thermometer [DT]) and anxiety (as measured by the State Anxiety Inventory [STAI-6]) in PBT patients
  • Measurement of mood disturbance [ Time Frame: End of Study ]
    To assess the effects of a VR intervention on self-reported mood disturbance (as measured by PROMIS - Anxiety & PROMIS - Depression Short Forms) and symptom burden and interference (as measured by the MD Anderson Symptom Inventory Brain Tumor [MDASI-BT])
  • Measurement of distress and anxiety [ Time Frame: End of Study ]
    To determine if the effects VR has on distress and anxiety are more pronounced in those with high distress (based on DT cut-off score of greater than or equal to 5) compared those with to low distress (based on DT scores of 0 4)
  • Measurement and comparison of distress and anxiety on those on systemic corticosteroids [ Time Frame: End of Study ]
    To determine if the effects VR has on distress and anxiety are more pronounced in those individuals not on systemic corticosteroids (CS) compared to those who are
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE Device: Pico G2 4K Headset with Applied VR software
headset worn at time points defined in study
Study Arms  ICMJE Experimental: Experimental intervention
Experimental VR Intervention, Survey or Questionnaire Completion and Sample Submission
Intervention: Device: Pico G2 4K Headset with Applied VR software
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: NCI NOB Referral Group (866) 251-9686 ncinobreferrals@mail.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04301089
Other Study ID Numbers  ICMJE 200065
20-C-0065
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Terri S Armstrong, C.R.N.P. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 28, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP