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

Not Applicable

Recruiting

• Conditions: Fear; Lung Cancer; Anxiety; Prostate Cancer; Head and Neck Cancer; Breast Cancer; Brain Tumor
• Interventions: Other: General questions; Other: Clinical data collected

• Registration Number: NCT06199050
• Lead Sponsor: Maastricht Radiation Oncology

Brief 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.

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 Timeline

• Study Start: 2023-06-16
• Study First Submitted: 2023-06-16
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-27
• Last Update Submitted: 2023-12-27
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
360° Virtual Reality Movies	Clinical data collected	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
360° Virtual Reality Movies	General questions	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
Group without intervention	Clinical data collected	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
Group without intervention	General questions	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

Primary Outcome Measures

Name	Time	Method
Subjective fear, anxiety and stress (QSC-R23)	1 month	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.
Subjective fear, anxiety and stress (SPIRIT)	1 month	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
Relationship between fear, anxiety, stress experience, and answers given in the standard PROMS questionnaire	1 month	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)?)
Subjective fear, anxiety and stress (PROMS)	1 month	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.
Subjective fear, anxiety and stress (HADS)	1 month	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
Relationship with demographics	1 month	Is there a relationship between fear, anxiety, stress experience, and the demographics of a patient.(I.e., prognosis, cancer indication, kind of treatment procedure)

Trial Locations

Locations (1)

Maastricht Radiation Oncology; 🇳🇱 Maastricht, Netherlands