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

BackgroundPsychological 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)EligibilityPBT 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 surveillanceAdults (greater than or equal to 18 years of age) who are English-speaking and able to self-report symptomsActive corticosteroid therapy is permissibleExclude patients without tissue diagnosis, recent cranial surgery (less than or equal to 2 weeks), scalp wound healing issues, or seizures within the last 6 weeksParticipants have reported greater than or equal to 1 on distres item from MDASI-BT prior to past clinic appointmentExclude patients who have a hypersensitivity to motion, severe nausea, or visual field deficits that might interfere with VR experienceExclude patients with a current diagnosis of generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), claustrophobia, or panic disorderDesignThis 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. A semi-structured qualitative interview will also be conducted 1 month 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..

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 13. März Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Anxiety Disorders Brain Neoplasms Phase: Phase 2 Recruitment Status: Recruiting Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: March 9, 2020, Last downloaded: ClinicalTrials.gov processed this data on March 20, 2024, Last updated: March 20, 2024

Study ID:

NCT04301089 200065 20-C-0065

Veröffentlichungen zur Studie:

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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PPN (Katalog-ID):	CTG000036935