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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Head and Neck Cancer; Anxiety; Lung Cancer; Prostate Cancer; Brain Tumor; Fear
• Intervention / Treatment: Other: Questionnaire: SPIRIT; Other: Questionnaire: HADS; Other: Questionnaire: QSC-R23; Other: General questions; Other: Clinical data collected

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 360° Virtual Reality Movies; assess the amount of fear, anxiety and stress by using specific questionnaires: SPecifIc RadIation Treatment related questions (SPIRIT); Hospital Anxiety and Depression Scale (HADS); Dutch version of the Questionnaire on stress symptoms (QSC-R23) 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: Age; Gender; Cancer type; WHO status; TNM	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.; Other: Questionnaire: HADS; Hospital Anxiety and Depression Scale, 14 questions likert scale; Other: Questionnaire: QSC-R23; Dutch version of the Questionnaire on stress symptoms, 23 questions likert scale; Other: 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; Other: Clinical data collected; Clinical data in HIX: Age; Gender; Cancer type; WHO status; TNM
Experimental: Group without intervention; In a measurement over 5 months without any intervention the investigators have assessed the amount of fear, anxiety and stress by using a specific subjective questionnaire on the items below: assess the amount of fear, anxiety and stress by using specific questionnaires: SPecifIc RadIation Treatment related questions (SPIRIT); Hospital Anxiety and Depression Scale (HADS); Dutch version of the Questionnaire on stress symptoms (QSC-R23) 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: Age; Gender; Cancer type; WHO status; TNM	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.; Other: Questionnaire: HADS; Hospital Anxiety and Depression Scale, 14 questions likert scale; Other: Questionnaire: QSC-R23; Dutch version of the Questionnaire on stress symptoms, 23 questions likert scale; Other: 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; Other: Clinical data collected; Clinical data in HIX: Age; Gender; Cancer type; WHO status; TNM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Investigators: Study Director: Cheryl Roumen, Maastricht University; Principal Investigator: Maria Jacobs, Maastro

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Actual): May 13, 2025
• Study Completion (Actual): May 13, 2025

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Skin Diseases; Breast Diseases; Nervous System Neoplasms; Central Nervous System Neoplasms; Skin and Connective Tissue Diseases; Prostatic Neoplasms; Anxiety Disorders; Lung Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Brain Neoplasms
• Other Study ID Numbers: ENGAGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No