The Effect of 360° Virtual Reality Movies on Fear and Anxiety

Breast Cancer Clinical Trial

— ENGAGE  

Official title:

The Effect of 360° Virtual Reality Movies on Fear and Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06199050
• Other study ID #: ENGAGE
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Maastricht Radiation Oncology
• Contact: Chiara Coleman
• Phone: +31 88 44 55 707
• Email: chiara.coleman[@]maastro.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the effect of web-based 360° Virtual Reality movies on fear and anxiety, The investigators would like to assess the patient-perceived level of fear and anxiety quantitatively, making use of several questionnaires.

Description:

In ENGAGE, a KWF Samenloop Voor Hoop subsidized project, we have developed VR movies to reduce fear and anxiety for patients who are going to be treated at Maastro. These movies are based on where most fear and anxiety are experienced and have been developed after extensive discussion with different disciplines in patient care and with agreement of the Director Patient Care. The movies include: 1) Mouldroom, 2) VMDIBH mamma photons, 3) Head and Neck photons, 4) Lung photons, 5) CT-scan, 6) Prostate photons, and 7) Head and Neck/ Neuro protons. Currently, the web-based 360° movies are implemented in clinical practice and the VR glasses with the 360° movies will be used as soon as social work has decided on where to integrate the use in the care pathway.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with breast- (only VMDIP), lung-, prostate-, head and neck cancer, a brain tumor.
• Age 18+
• Being able to speak, read and write in Dutch
• General interview between radiation oncologist and patient (= Intake)
• Ability to give written informed consent before the start of the study
• Decision talk about start of treatment must have taken place

Exclusion Criteria:

• Patients who are already receiving radiotherapy treatment
• Pre-operative consultation for breast cancer patients
• Patients who have seen the VR-videos already

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Brain Tumor
• Breast Cancer
• Fear
• Head and Neck Cancer
• Lung Cancer
• Prostate Cancer

Intervention

Other:
• Questionnaire: SPIRIT
T0: Before the first intake at Maastro, the Trialpoli (TP) contacts a patient via phone to inform whether or not he is interested in participating in this study. If the patient shows interest in participating in the study, he will be invited for a consultation with the Trialpoli. This consultation takes place on the day of intake at Maastro. After consent, the patient is randomized to fill out T0 before or after the intake. T1: After filling out T0, the patient receives the ENGAGE information card with the url en QR code to the VR-movie. After watching the VR movie and before start RT the patient is asked to fill in T1. This questionnaire is distributed with instructions by the TP. T2: Between the 5th and the 15th radiation treatment, patients will be asked to fill in the questionnaires for the third and last time. The Patient Information Form (PIF) and Informed Consent (IC) are added in a separate document.
• Questionnaire: HADS
Hospital Anxiety and Depression Scale, 14 questions likert scale
• Questionnaire: QSC-R23
Dutch version of the Questionnaire on stress symptoms, 23 questions likert scale
• General questions
Education level Marietal status Medication use (in order to assess influence on fear) Previous cancer diagnosis Acquired information on treatment Expected fear and anxiety mitigation strategies Other cancer treatments (e.g. chemotherapy no, prior to RT, during RT, or after RT; surgery prior to or after RT) PROM at baseline
• Clinical data collected
Clinical data in HIX: Age Gender Cancer type WHO status TNM

Locations

Country	Name	City	State
Netherlands	Maastricht Radiation Oncology	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective fear, anxiety and stress (QSC-R23)	What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the Questionnaire on Stress in Cancer Patients revised version (QSC-R23). Dutch version of the Questionnaire on stress symptoms (QSC-R23) - 23 questions likert scale.	1 month
Primary	Subjective fear, anxiety and stress (PROMS)	What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the Patient Reported Outcome Measures (PROMS) questionnaires. Patient reported outcome measures.	1 month
Primary	Subjective fear, anxiety and stress (HADS)	What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the Hospital Anxiety and Depression Scale (HADS). Hospital Anxiety and Depression Scale (HADS) - 14 questions likert scale	1 month
Primary	Subjective fear, anxiety and stress (SPIRIT)	What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the additional treatment-specific questions (SPIRIT). SPecifIc RadIation Treatment related questions (SPIRIT) - 10 questions likert scale	1 month
Primary	Relationship with demographics	Is there a relationship between fear, anxiety, stress experience, and the demographics of a patient.(I.e., prognosis, cancer indication, kind of treatment procedure)	1 month
Primary	Relationship between fear, anxiety, stress experience, and answers given in the standard PROMS questionnaire	Is there a relationship between fear, anxiety, stress experience, and answers given to specific questions in the standard PROMS questionnaire. (e.g., the general quality of life questionnaire (EQ5D), especially on FEAR and DEPRESSION and health-related quality of life (SF-36)?)	1 month