Virtual Reality to Promote Mindfulness and Relaxation Prior to Radiation Simulation: A Prospective Pilot Feasibility Study
Phase: NA
Conditions: Cancer
Sponsor: Abramson Cancer Center at Penn Medicine

 
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CLINICAL RESEARCH PROTOCOL 
 
INVESTIGATIONAL 
PRODUCT(S): 
 
Virtual Reality program developed by Novobeing (formerly 
Rocket VR). To be administered on HTC Vive Flow, HTC 
Vive Focus or Pico Neo Pro headsets 
STUDY 
NUMBER(S): 
IRB 
Number 
854756 
Other 
Protocol 
Identifiers  
UPCC# 14523 
PROTOCOL(S) TITLE: 
Virtual Reality to Promote Mindfulness and Relaxation prior to 
Radiation Simulation: A Prospective Pilot Feasibility Study 
REGULATORY 
SPONSOR: 
N/A 
FUNDING SPONSOR(S): 
N/A 
PRINCIPAL 
INVESTIGATOR 
SUB-INVESTIGATORS 
 
 
 
 
STATISTICIAN 
Michael LaRiviere, MD 
 
William Levin, MD 
Michelle Iocolano, MD 
Steven Feigenberg, MD 
Jeffrey Bradley, MD 
 
Scott Appel, MS 
VERSION NUMBER: 
V4 
VERSION DATE: 
10/20/2025 
 
 
 

 
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1 
Study Summary .......................................................................................................... 6 
1.1 
Synopsis .................................................................................................................. 6 
1.2 
Key Roles and Study Governance ....................................................................... 8 
1.3 
Schema ................................................................................................................... 9 
2 
Introduction and RationalE .................................................................................... 10 
2.1 
Study Rationale ................................................................................................... 10 
2.2 
Background .......................................................................................................... 10 
2.2.1 
Clinical Adverse Event Profile ..................................................................... 11 
2.3 
Risk/Benefit Assessment ..................................................................................... 11 
2.3.1 
Known Potential Risks .................................................................................. 11 
2.3.2 
Known Potential Benefits ............................................................................. 11 
2.3.3 
Assessment of Potential Risks and Benefits ................................................ 12 
3 
Study Objectives and Endpoints............................................................................. 13 
4 
Study Plan ................................................................................................................. 14 
4.1 
Study Design ........................................................................................................ 14 
4.2 
Scientific Rationale for Study Design ................................................................ 14 
4.3 
End of Study Definition ...................................................................................... 14 
5 
Study Population ...................................................................................................... 15 
5.1 
Inclusion Criteria ................................................................................................ 15 
5.2 
Exclusion Criteria ............................................................................................... 15 
5.3 
Screen Failures .................................................................................................... 15 
5.4 
Strategies for Recruitment and Retention ........................................................ 16 
6 
Study Intervention ................................................................................................... 18 
6.1 
Study Intervention(s) Administration ............................................................... 18 
6.1.1 
Study Intervention Description .................................................................... 18 
6.2 
Preparation/Handling/Storage/Accountability ................................................ 19 
6.2.1 
Acquisition and accountability .................................................................... 19 
6.2.2 
Formulation, Appearance, Packaging, and Labeling ................................ 19 
6.2.3 
Product Storage and Stability ...................................................................... 19 
6.2.4 
Preparation .................................................................................................... 19 
6.3 
Measures to Minimize Bias: Randomization and Blinding ............................. 19 
6.4 
Study Intervention Compliance ......................................................................... 20 
6.5 
Concomitant Therapy ......................................................................................... 20 
6.5.1 
Rescue Medicine ............................................................................................ 20 
7 
Study Intervention Discontinuation and Participant 
Discontinuation/Withdrawal ................................................................................... 21 
7.1 
Discontinuation of Study Intervention .............................................................. 21 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................... 21 
7.3 
Lost to Follow-Up ................................................................................................ 22 
8 
Study Assessment and Procedures ......................................................................... 23 
8.1 
Efficacy Assessments ........................................................................................... 23 
 

 
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8.2 
Safety and Other Assessments ........................................................................... 24 
8.3 
Time Period and Frequency for Event Assessment and Follow-Up ............... 24 
9 
Statistical Considerations ........................................................................................ 24 
9.1 
Statistical Hypotheses ......................................................................................... 24 
9.2 
Sample Size Determination ................................................................................ 24 
9.3 
Populations for Analyses .................................................................................... 25 
9.4 
Statistical Analyses .............................................................................................. 25 
9.4.1 
Analysis of the Primary Efficacy Endpoint(s) ............................................ 25 
9.4.2 
Analysis of the Secondary Endpoint(s) ....................................................... 25 
9.4.3 
Baseline Descriptive Statistics ...................................................................... 25 
9.4.4 
Tabulation of Individual Participant Data ................................................. 25 
10 Supporting Documentation and Operational Considerations ............................. 26 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ............................. 26 
10.1.1 
Informed Consent Process ............................................................................ 26 
10.1.2 
Study Discontinuation and Closure ............................................................. 26 
10.1.3 
Confidentiality and Privacy ......................................................................... 27 
10.1.4 
Future Use of Stored Data ............................................................................ 27 
10.1.5 
Safety Oversight ............................................................................................ 28 
10.1.6 
Clinical Monitoring ....................................................................................... 28 
10.1.7 
Data Handling and Record Keeping ........................................................... 28 
10.1.8 
Protocol Deviations ....................................................................................... 29 
10.1.9 
Publication and Data Sharing Policy .......................................................... 30 
10.1.10 
Conflict of Interest Policy ............................................................................. 30 
10.2 
Protocol Amendment History ............................................................................ 30 
11 References ................................................................................................................. 31 
12 APPENDIX ............................................................................................................... 33 
12.1 
Schedule of Activities (SoA) ............................................................................... 33 
12.2 
Questionnaires ..................................................................................................... 36 
 
 
 
 
PRINCIPAL INVESTIGATOR SIGNATURE 
 
STUDY 
SPONSOR: 
N/A 

 
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STUDY TITLE: 
Virtual Reality to Promote Relaxation Prior to Radiation Simulation: A 
Prospective Pilot Feasibility Study 
STUDY ID 
PROTOCOL 
VERSION 
IRB# 854756 / UPCC# 14523 
V3 
I have read the referenced protocol. I agree to conduct the study in accordance to this protocol, in 
compliance with the Declaration of Helsinki, Good Clinical Practices (GCP), and all applicable 
regulatory requirements and guidelines. 
Principal 
Investigator Name  
 
 
Signature 
 
Affiliation: 
 
 
Date 
 
 
 
 
 
 
 

 
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Abbreviations 
RT: Radiation Treatment 
3D: Three dimensional 
VR: Virtual Reality  
CRC: Clinical research coordinator 
 

 
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1 STUDY SUMMARY 
1.1 
Synopsis 
Title:  
Virtual Reality to Promote Relaxation Prior to Radiation Simulation: A 
Prospective Pilot Feasibility Study 
Short Title: 
Virtual Reality to Promote Relaxation Prior to Simulation 
Study 
Description:  
The purpose of this study is to assess the feasibility of a pre-simulation 
virtual reality (VR) platform designed to promote relaxation for cancer 
patients planned for radiation therapy (RT). We hypothesize that at least 
75% of enrolled patients will successfully complete the VR program.  
Objectives:  
Primary Objective:  
1. To evaluate the feasibility of a pre-simulation VR platform prior 
to radiation. 
Secondary Objectives: 
1. To evaluate patient feedback on pre-simulation VR program  
2. To evaluate patient situational anxiety prior to and after use of VR 
program 
Primary 
Endpoint:  
Feasibility based on the ability of at least 75% patient VR completion 
rate. Based on the expected accrual of 25 patients, futility and early 
termination will be triggered if six participants fail to meet the conditions 
described above. 
Secondary 
Endpoints: 
1. To evaluate patient-reported situational anxiety levels prior to and 
after use of the VR headset.  
2. To collect patient feedback on the usability of and overall 
satisfaction with the VR program prior to simulation.  
Study 
Population: 
Adult radiation oncology patients at least 18 years of age who are 
undergoing radiation treatment at the Perelman Center for Advanced 
Medicine. 
Phase: 
Pilot Study 
 

 
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Description of 
Sites/Facilities  
Department of Radiation Oncology at Perelman Center for Advanced 
Medicine 
Enrolling Sites: 
Department of Radiation Oncology at Perelman Center for Advanced 
Medicine 
Description of 
Study 
Intervention: 
The program is designed to be used as a relaxation tool prior to RT using 
a HTC or Pico VR headset. It is a three-dimensional (3D) auditory and 
visual immersive experience using scenery, sounds and narration to help 
patients relax and reduce anxiety prior to RT planning simulation. 
Study Duration: 
12 months 
 
Participant 
Duration: 
One day 
 
 
 
 
 
 

 
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1.2 
Key Roles and Study Governance 
 
Sponsor 
Medical Director 
N/A 
Michael LaRiviere, MD 
 
Penn Medicine  
 
3400 Civic Center Blvd. Philadelphia, PA 19104 
 
267-760-7895 
 
Michael.lariviere@pennmedicine.upenn.edu 
 
 

 
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1.3 
Schema 
Please note that after patients are screened for eligibility, study intervention will take place on 
one day, prior to scheduled simulation for radiation treatment planning. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening  
Prior to the day of simulation, potential study participants will be pre-screened by 
inclusion and exclusion criteria. Baseline demographics will be collected from the 
electronic medical record. 
Pre-Intervention Phase 
On day of and prior to simulation, baseline assessments will be completed:  
- 
HADS questionnaire* 
- 
STAI-6 questionnaire*  
*Appendix 
Intervention Phase 
VR-based intervention will be administered immediately after baseline 
questionnaires are completed 
While participants are encouraged to view the entire program, they may 
either temporarily or permanently remove the VR headset at their preference.  
If the program is permanently discontinued prior to completion, feasibility 
criteria is not met if the patient did not watch at least 8 minutes. 
Post-Intervention Phase- Study End 
- 
Perform follow-up assessments immediately after VR intervention:  
- 
STAI-6 questionnaire* 
- 
Usability survey* 
*Appendix 
Enrollment 
N= 25 
On day of and prior to simulation, informed consent will be obtained.  Eligibility 
will be obtained and signed off on. 
 

 
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2 INTRODUCTION AND RATIONALE 
2.1 
Study Rationale 
It is well documented in the literature that cancer patients experience disproportionate 
rates of psychologic distress and anxiety compared to the general population [1-3]. The National 
Cancer Comprehensive Network (NCCN) defines distress as a “multifactorial, unpleasant 
experience of a psychological (i.e. cognitive, behavioral, emotional), social, spiritual, and/or 
physical nature that may interfere with one’s ability to cope effectively with cancer, its physical 
symptoms and its treatment” [4]. In turn, cancer-related distress is associated with decreased 
adherence to treatment, satisfaction with care, quality of life and overall survival [5-8]. 
Interventions to mitigate psychologic distress in this patient population are critical to the delivery 
of high quality, patient-centered care. VR provides a non-invasive, low cost, immersive 
experience that may help mitigate distress and anxiety associated with starting active cancer 
treatment. The purpose of this pilot feasibility study is to assess the role of a VR-based platform 
that utilizes mindfulness-based practices to distract and relax patients prior to the start of RT.  
2.2 
Background 
Mindfulness meditation is a well-established technique for stress reduction across 
multiple patient populations [9]. It emphasizes attention to the present moment and acceptance of 
one’s thoughts, feelings and bodily sensations without judgment. In cancer patients, mindfulness-
based interventions have been found to decrease psychologic distress, improve quality of life and 
reduce fear of cancer recurrence [10-12].  A meta-analysis of 28 randomized control trials of 
over 3,000 adult cancer patients found that mindfulness-based interventions reduced anxiety and 
depression severity up to six months after the initial intervention [13]. These interventions were, 
however largely delivered in person which may prove to be a barrier for patients with limited 
resources. 
Virtual reality (VR) has recently become a widely available and affordable non-invasive 
technology that may be implemented in the clinical setting. VR provides viewers a visual and 
auditory experience via a head mounted display. Its potential as an evidence-based, therapeutic 
device is an area of active research in cancer patients. In one study, when VR was used as a 
distraction device, patients report reduced cancer-related anxiety, depression and pain [14-15]. 
When utilized during chemotherapy infusions, patients felt treatment time was shortened and 
found the program enjoyable [16]. While these studies use VR as a distraction device, little is 
known in regards to efficacy of VR-based mindfulness meditation. The incorporation of 
mindfulness meditation principles with VR is currently being investigated in patients with 
chronic pain [17]. To our knowledge, the use of a VR based platform to promote relaxation has 
never been implemented in the oncologic setting. 
In this study, we will utilize a VR-based, immersive scene designed for relaxation and 
promotion of mindfulness-based principles for patients who are planned for radiation simulation. 

 
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The primary objective of this study is to assess the feasibility of a VR platform prior to 
simulation into patient workflows. Secondary objectives include patient-reported situational 
anxiety pre- and post- VR and qualitative and quantitative patient feedback on usability and 
satisfaction with the VR device. 
2.2.1 
Clinical Adverse Event Profile 
We anticipate minimal discomfort from study participation. Subjects may experience discomfort 
from using VR including headache, dizziness, lightheadedness, vision problems, nausea, 
vomiting, ect. which is expected, temporary, and should resolve within 24 hours. This kind of 
discomfort is not considered an adverse event. Patients with active nausea, vomiting, dizziness, 
lightheadedness, monocular vision or hearing loss that is not treated at time of enrollment, a 
history of motion sickness, car sickness, migraines, light sensitivity or vertigo within the last 6 
months, or a history of epilepsy and seizures will be excluded from the study via screening 
procedures as these may place patients at higher risk. 
2.3 
Risk/Benefit Assessment 
2.3.1 
Known Potential Risks 
Individuals will be identifiable during the data collection phase, but not when the data is 
disseminated. Subjects may experience discomfort while wearing the VR headset. They will be 
notified that they can stop anytime and participation is completely voluntary. Participation, lack 
of participation, withdrawal or any other factor related to involvement in this study will have no 
impact on the subjects’ care.  
2.3.2 
Known Potential Benefits 
This study may have benefits for both the study participants and for society in general. 
Participation will provide patients with a method for relaxation based in mindfulness meditation 
principles prior to initiation of RT.  
We will collect patient feedback in regards to the VR experience which can inform development 
of new virtual reality-based programs designed to improve the experience of patients undergoing 
active cancer treatment. 
This study is grounded in patient-centered care with the goal of improving the overall experience 
during active cancer care which is in line with the strategic goals of the Department. 
Society in general may benefit from the knowledge generated by this trial, particularly with 
respect to improving the patient-experience, reducing patient distress and anxiety and informed 
consent. 

 
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2.3.3 
Assessment of Potential Risks and Benefits 
This study is expected to introduce minimal risk to study participants with potential benefit of 
promoting a patient-centered experience.  

 
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3 STUDY OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
Demonstrate feasibility of VR prior to 
radiation simulation for treatment 
planning. 
This is a feasibility study. Feasibility is 
based on the ability of at least 75% of 
study participants to complete a VR 
program prior to simulation. Based on the 
expected accrual of 25 patients, futility 
and early termination will be triggered if 
six participants fail to meet the conditions 
described above.  
 
 
To assess patient 
participation in an 
immersive VR experience 
prior to radiation 
simulation.  
 
Secondary 
 
 
Assess degree of baseline anxiety prior 
to study intervention 
 
Measure baseline score on Hospital 
Anxiety and Depression Scale (HADS) 
Assess degree of patient-
reported anxiety prior to 
use of VR-based 
intervention. 
Assess efficacy of VR program to 
reduce situational anxiety.  
Measure change in STAI-6 score at 
baseline and after VR intervention. 
Assess degree to which 
use of VR program 
changes scores on STAI-6 
from baseline. This 
questionnaire is designed 
to measure situational 
anxiety. 
Collect feedback on VR ease of use and 
patient satisfaction with the experience. 
Post-intervention survey designed to 
collect qualitative and quantitative patient 
feedback. 
Questionnaire will be 
administered after 
intervention to assess 
degree of patient 
satisfaction, ease of use 
and perceived quality of 
the VR program. 

 
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4 STUDY PLAN 
4.1 
Study Design 
The purpose of this prospective feasibility study is to assess the implementation of a VR-based 
intervention in patients who are pending initiation of RT. We hypothesize that this intervention 
will be safe and feasible. If 75% of enrolled patients complete the VR intervention (defined as at 
least 8 min before permanent discontinuation), then feasibility will be met. Ten minutes’ length 
is likely to be tolerated by most patients and likely to provide benefit. The maximum length of 
the VR video is 11 minutes. Patients will still be evaluable after 8 minutes of the video as this 
provides ample time to practice mindfulness based breathing exercises.  
As this is a feasibility study, investigators and participants will not be blinded to study 
procedures. Potential study participants will be adult patients who are undergoing simulation for 
radiation treatment planning at the Perelman Center for Advanced Medicine at Penn Medicine. 
This is a single site study. No interim analyses or sub-studies are planned. Based on the expected 
accrual of 25 patients, futility and early termination will be triggered if 6 participants fail to meet 
the conditions described above. 
4.2 
Scientific Rationale for Study Design 
The purpose of this study is to ensure feasibility and ease of implementation of a VR device into 
established clinic patient workflows. All enrolled participants will receive the study intervention. 
There is no control arm. 
4.3 
End of Study Definition 
A participant is considered to have completed the study if he or she has completed all phases of 
the study including completion of the follow up assessments [Appendix]. 
 

 
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5 STUDY POPULATION 
5.1 
Inclusion Criteria 
 In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
1. Able to understand, read or speak English sufficient for signing of informed consent and 
completion of study assessments 
2. Patients scheduled for simulation for radiation treatment planning at Perelman Center for 
Advanced Medicine (PCAM) 
3. Adults, at least 18 years of age 
4. Performance Status (ECOG) 0-2 
 
5.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1. Prior radiotherapy 
2. History of motion sickness, car sickness, vertigo, migraines, or light sensitivity within the 
last 6 months 
3. History of epilepsy and seizures 
4. Current nausea, vomiting, dizziness, lightheadedness, monocular vision or hearing loss that is 
not treated 
5.3 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical trial but are 
not subsequently entered in the study. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure participants, to meet the Consolidated Standards of 
Reporting Trials (CONSORT) publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes demography, screen failure details, eligibility criteria, 
and any serious adverse event (SAE). 
Research staff will explain the nature of the study protocol and risks associated with the protocol 
in detail to the subject. The subject must sign and date the written informed consent prior to 
study participation. Informed consent process must be obtained before protocol procedures are 
performed. If a procedure required for screening was performed prior to signing the informed 
consent and the procedure meets the time limits of the protocol, this procedure may be used for 
the screening evaluation. 
 

 
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Screening will be completed prior to administration of the baseline questionnaires or VR 
intervention. Patients who enroll but do not use the VR headset will not factor into determination 
of study feasibility. 
  
Screening includes:  
• Consulting investigator confirms that (s)he plans to recommend radiotherapy simulation at 
Perelman Center for Advanced Medicine. 
• Complete the pre-screening questionnaire. 
• Complete medical history. 
• Informed consent. 
• Confirmation that inclusion and exclusion criteria are met.  
 
Prior to informed consent, study procedures will be explained in detail to assess interest in the 
study. If the patient expresses interest in the study, the patient will be asked the pre-screening 
questionnaire designed to assess for those who may be at increased risk of side-effects from VR. 
Patients who indicate a history of motion sickness, car sickness,  migraines, light sensitivity or 
vertigo within the last 6 months will be excluded from the study. Patients who indicate a history 
of epilepsy or seizures will be excluded from the study. Patients with active nausea, vomiting, 
headaches, dizziness, lightheadedness will also be excluded. The pre-screening questionnaire is 
listed in the Appendix. 
 
5.4 
Strategies for Recruitment and Retention 
• Target study sample expected to be drawn primarily from the thoracic radiation oncology 
patient population in the Department of Radiation Oncology at Penn Medicine. 
• Patients may undergo head imaging per National Comprehensive Cancer Network 
(NCCN) guidelines version 3.2023 
• Anticipated accrual rate of 2-4 patients per week. 
• After patients are screened, study intervention will take place on the day of simulation for 
radiation planning. 
• Subjects will be recruited at the Perelman Center for Advanced Medicine.  
• Patients will be approached prior to their radiation simulation. Simulation schedules will 
be prescreened prior to patient visits and potential study participants will be identified. 
The research staff will approach and inform the patient about the study and explain study 
procedures. If the patient expresses interest in the study, the patient will be asked the pre-
screening questionnaire. If the patient passes the pre-screening questionnaire, the research 
staff will plan to meet with the patient prior to their radiation simulation to conduct 

 
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informed consent and the study visit. Basic demographic data will be collected from the 
medical record. 
• On day of and prior to simulation, the person obtaining consent will explain the 
requirements of the study, state the volunteer nature of research, and advise the patient to 
take sufficient time to discuss the study if necessary before making their decision to sign 
the informed consent document. Patients will be informed that participation in this study 
will not affect their medical care. If a decision to participate is made, the informed 
consent form will be signed. A copy of the Informed Consent Form will be provided to 
the patient. Eligibility will be confirmed with the study investigator or delegate.  
• Information of this study’s availability will be made known to treating professionals 
throughout our practice and referring physicians. 

 
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6 STUDY INTERVENTION 
6.1 
Study Intervention(s) Administration 
Study intervention will take place in one day. Prior to simulation, the research staff will seat 
participants in a semi-private area. A head mounted, HTC Vive Flow, HTC Vive Focus, or Pico 
Neo Pro device will be provided. The VR headsets will not collect any patient data. The headset 
will be adjusted accordingly for comfort prior to turning on the device. Patients will be reminded 
that they can take a break or stop at any time. They will also be instructed to alert staff if they are 
feeling unwell at any point during the VR experience.  
6.1.1 
Study Intervention Description 
Prior to using the VR headset, patients will be asked to complete electronic-based, multiple 
choice, pre-intervention surveys [Appendix]. Questionnaires are designed to assess baseline 
anxiety and situational anxiety. Study participants will be provided a HTC or Pico VR head-
mounted device (HTC Flow, HTC Focus or Pico Neo Pro) which will be fitted for comfort. 
Patients will remain seated for the entirety of the VR program. The program generally takes 
about ten minutes to complete but may last up to 11 minutes. Participants will be reminded they 
may stop at any time. They may also temporarily or permanently take off the headset at any time 
for any reason. The patient must voluntarily express interest in proceeding prior to the headset 
being replaced.  
 
The program is designed to last for ten minutes in order to ensure subjects have adequate time to 
watch a short orientation video where the purpose of the VR exercise is explained and to practice 
breathing exercises. Ten minutes’ length is likely to be tolerated by most patients and likely to 
provide benefit. Patients will provide feedback on the length of the video which can be 
incorporated into future studies. The program displays a relaxing environmental setting with 
narration based in mindfulness meditation principles. Subjects will be prompted to practice 
breathing exercises designed to relax and reduce anxiety.  
 
After the VR immersion is complete, patients will be verbally assessed by staff to ensure they 
have no side effects from the program. Patient will then complete the post-intervention 
questionnaires via electronic survey. Questionnaires will be administered to assess situational 
anxiety and elicit feedback on participant experience and satisfaction with VR. Once the 
questionnaires are complete, all study tasks are complete. 
 
 
 

 
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6.2 
Preparation/Handling/Storage/Accountability 
6.2.1 
Acquisition and accountability 
HTC or Pico VR headsets and software will be provided by Novobeing (formerly Rocket VR) or 
the University of Pennsylvania Department of Radiation Oncology. Headsets will be checked for 
quality control by research staff prior to use.  
6.2.2 
Formulation, Appearance, Packaging, and Labeling 
Clinical supplies will be affixed with a clinical label in accordance with regulatory requirements. 
This trial is open-label; therefore, the subject, the trial site personnel, and/or designee are not 
blinded to treatment. Random code/disclosure envelopes or lists are not provided. 
 
Each headset will undergo specialized cleaning procedures after patient use.  
6.2.3 
Product Storage and Stability 
Clinical supplies must be stored in a secure, limited-access location. 
6.2.4 
Preparation 
Headset Cleaning Procedures: 
• Interior and exterior aspects of VR headsets and controllers will be cleaned between each 
use. 
• A germicidal, alcohol-based cleaning wipe will be used on the interior and exterior 
aspects of the headset and controllers. A microfiber cloth or non-alcohol-based pad will 
be used to clean the headset lenses. 
• Study staff will wash hands prior to cleaning and use nitrile gloves while cleaning study 
equipment. The gloves will be disposed of after use. 
• All equipment will completely air dry (for approximately 2 minutes) after cleaning prior 
to next use. 
6.3 
Measures to Minimize Bias: Randomization and Blinding 
Given this is a pilot feasibility study, patients will not be randomized. All enrolled participants 
will receive the intervention. As such, research staff will not be blinded. 

 
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6.4 
Study Intervention Compliance 
Compliance with the study procedures will be monitored by the research staff and includes 
participation in all required study visits and completion of all baseline and end-of-study surveys 
by participants. 
6.5 
Concomitant Therapy 
N/A 
6.5.1 
Rescue Medicine 
N/A 

 
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7 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 
Discontinuation of Study Intervention 
Discontinuation of the VR headset does not mean discontinuation from the study. A patient may 
ask to temporarily remove the VR headset or may himself/herself temporarily remove the VR 
headset. However, the patient must voluntarily express interest in proceeding, replace the VR 
headset, and subsequently complete 8 minutes of the VR program in order to meet feasibility 
criteria. 
Subjects who permanently remove the VR headset early will be asked to complete the follow up 
surveys, and verbal and written subjective feedback will be solicited from the patient.  
7.2 
Participant Discontinuation/Withdrawal from the Study 
Subjects may withdraw consent at any time for any reason or be dropped from the trial at the 
discretion of the investigator should any untoward event occur. In addition, a subject may be 
withdrawn by the investigator if enrollment into the trial is inappropriate, the trial plan is 
violated, or for administrative and/or other safety reasons.  A subject must be discontinued from 
the trial for any of the following reasons: 
• The subject or legal representative (such as a parent or legal guardian) withdraws consent 
• Unacceptable adverse experiences 
• Intercurrent illness that prevents further administration of intervention 
• Investigator’s decision to withdraw the subject 
• Noncompliance with trial treatment or procedure requirements 
• Administrative reasons 
 
Subjects who sign the informed consent form but withdraw or are dropped from the trial at the 
discretion of the investigator prior to use of the VR headset may be replaced. Subjects who sign 
the informed consent form, use the VR intervention and then subsequently withdraw, or are 
withdrawn/discontinued from the study, prior to completing 8 minutes of the program will not be 
replaced and will count towards feasibility. 
 

 
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7.3 
Lost to Follow-Up 
Study intervention will take place on the day of the subject’s radiation simulation appointment. 
There are no follow up procedures. 

 
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8 STUDY ASSESSMENT AND PROCEDURES 
 
8.1 
Efficacy Assessments 
During pre-screening, basic demographic data including gender, age, race/ethnicity, primary 
cancer diagnosis, performance status and radiation treatment plan will be collected from the 
medical record.  
Secondary endpoints will be collected via electronic surveys. A baseline assessment of anxiety 
will be obtained using the Hospital Anxiety and Depression scale (HADS) validated tool. This 
tool has been used extensively in the oncologic setting and in patients receiving radiation therapy 
[20-21]. The HADS is a 14-item scale with seven items for each anxiety and depression. 
Subscale scores greater than 8 denotes anxiety or depression. It was designed to detect anxiety 
and depression in the general population [22]. Given high rates of baseline anxiety in cancer 
patients, the HADS will be administered to document the prevalence of generalized anxiety. This 
instrument will take approximately three minutes to complete. If the HADS score is noted to be 8 
or higher for any study participant, the PI or other clinical staff will assess patient to determine if 
a referral to mental health services is warranted. If deemed appropriate, the primary clinical team 
will also be notified.  
Situational anxiety will be assessed with the state-trait anxiety inventory (STAI-6). The STAI-6 
is adapted from the original 20-item STAI [23-24]. The original STAI scores range from 20-80. 
A score of 40 or higher is correlated with high anxiety [23]. The STAI-6 consists of six questions 
rated on a 1-4 Likert scale creating a score range from 6 to 24 [24]. In order to generate scores 
compatible with the original STAI, STAI-6 scores will be multiplied by 20 and divided by 6 to 
give a range between 20-80. This instrument has previously been used to assess situational 
anxiety in patients receiving radiation treatment [25]. This instrument will take appropriately two 
minutes to complete. 
The VR immersion will last approximately ten minutes to allow patients ample time to view the 
brief orientation video and practice mindfulness principles. The primary endpoint of this study is 
feasibility. In order to be counted towards feasibility, at least 75% of enrolled patients must 
participate in the VR immersion for a minimum of 8 minutes. If a patient withdraws from the 
study prior to the VR immersion, they will not be counted towards feasibility. Patients may ask 
to temporarily remove the VR headset or remove the VR headset themselves at any time. They 
must express a desire to complete the program before the head-mounted device is re placed. 
Patients may also permanently discontinue the VR immersion at any time for any reason. Post-
intervention STAI-6 will assess for change in situational anxiety. We will also obtain patient 
feedback on his or her VR experience with both multiple choice and free response questions. 
This usability survey will take between 7-10 minutes to complete.  

 
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8.2 
Safety and Other Assessments 
Patients will be asked to provide feedback on their comfort level during the VR experience 
verbally. If the patient indicates discomfort, the VR experience will be terminated. Patients will 
also be verbally assessed at the end of the VR immersion to ensure no untoward side effects. 
 
The virtual reality technology device is not expected to have any impact on safety as it involves 
the use of a headset in the up-right seated position. Patients will be provided contact information 
of the investigators should any concerns arise regarding device safety or overheating. Patients 
with significant pre-existing medical history that may predispose to higher risk of side effects 
will be excluded from the trial as described in section 5. 
 
8.3 
Time Period and Frequency for Event Assessment and Follow-Up 
Patients will be asked to provide feedback on their comfort level during the VR experience 
verbally as well as in the Usability survey. If the patient indicates discomfort, the VR experience 
will be terminated. The study team will track how many patients were unable to complete the VR 
program and the reason they were unable to complete the VR program. 
 
Subjects may experience discomfort during the VR immersion, such as temporary headache, 
dizziness, lightheadedness, vision problems, nausea, vomiting, etc. which is expected, temporary, 
and should resolve within 24 hours. This kind of discomfort is not considered an adverse event. 
9 STATISTICAL CONSIDERATIONS 
9.1 
Statistical Hypotheses 
• The primary endpoint is feasibility based on participants to successfully complete the VR 
immersion. For VR to be deemed feasible, these conditions must be met for at least 75% 
of participants. Based on the expected accrual of 25 patients, futility and early 
termination will be triggered if 6 participants fail to meet the conditions described above. 
• Secondary Efficacy Endpoint(s): 
1. Patient survey results defined as a change in post- and pre- VR immersion survey values as 
assessed by the STAI-6.  
2. Patient-reported feedback on VR immersive experience as collected in a Usability survey. 
This will be assessed with multiple choice and open-ended questions. 
9.2 
Sample Size Determination 
For this feasibility study, we aim to recruit 25 patients. Using the primary outcome of completion 
of a minimum of 8 minutes of VR immersion, 25 patients will allow us to identify the feasibility 

 
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target of 75% of patient completion rate with an 80% confidence interval 60%-86% (Clopper-
Pearson exact) [18-19]. 
9.3 
Populations for Analyses 
Data collected from all enrolled participants will be analyzed. Additional data will be collected 
by medical record review when needed for analysis. 
9.4 
Statistical Analyses 
9.4.1 
Analysis of the Primary Efficacy Endpoint(s) 
For the primary endpoint of feasibility: 
The overall feasibility will be calculated, dividing the number of patients who successfully 
completed 8 minutes of the VR immersion, over the total number of enrolled patients. Following 
an intent to treat analysis, all patients who enrolled and participated in the VR immersion, represent 
the denominator. The primary endpoint will be met if 75% of these patients meet feasibility criteria.  
9.4.2 
Analysis of the Secondary Endpoint(s) 
- 
The STAI-6 is adapted from the original 20-item STAI [21-22]. The original STAI scores 
range from 20-80. A score of 40 or higher is correlated with high anxiety [21]. The STAI-6 
consists of six questions rated on a 1-4 Likert scale creating a score range from 6 to 24 [22]. 
In order to generate scores compatible with the original STAI, STAI-6 scores will be 
multiplied by 20 and divided by 6 to give a range between 20-80. Changes in situational 
anxiety scores (when comparing post-VR to pre-VR immersion) will be tested using a paired 
t-test, assuming the differences between the scores are normally distributed. If they are 
normally distributed, a nonparametric test will be used (Wilcoxon signed-rank test).  
9.4.3 
Baseline Descriptive Statistics 
Baseline and demographic characteristics will be summarized by standard descriptive statistics 
(including mean and standard deviation for continuous variables such as age and frequency and 
percentage for categorical variables such as gender).   
9.4.4 
Tabulation of Individual Participant Data 
Individual participant data may be listed by measure. There is only one-time point in this study. 

 
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10 SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1 
Regulatory, Ethical, and Study Oversight Considerations 
10.1.1 
Informed Consent Process 
Consent forms will be provided describing study procedures in detail. Written documentation of 
informed consent is required prior to starting the study intervention. 
10.1.1.1 
Consent Procedures and Documentation 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in 
the study and continues throughout the individual’s study participation. Consent forms will be 
Institutional Review Board (IRB)-approved and the participant will be asked to read and review 
the document. The investigator or designee will explain the research study to the participant and 
answer any questions that may arise. A verbal explanation will be provided in terms suited to the 
participant’s comprehension of the purposes, procedures, and potential risks of the study and of 
their rights as research participants. Participants will have the opportunity to carefully review the 
written consent form and ask questions prior to signing. The participants should have the 
opportunity to discuss the study with their family or surrogates or think about it prior to agreeing 
to participate. The participant will sign the informed consent document prior to any procedures 
being done specifically for the study. Participants must be informed that participation is 
voluntary and that they may withdraw from the study at any time, without prejudice. A copy of 
the informed consent document will be given to the participants for their records. The informed 
consent process will be conducted and documented in the source document (including the date), 
and the form signed, before the participant undergoes any study-specific procedures. The rights 
and welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
10.1.2 
Study Discontinuation and Closure 
This study may be temporarily suspended or prematurely terminated by the PI if there is 
sufficient reasonable cause. If the study is prematurely terminated or suspended, the Principal 
Investigator (PI) will promptly inform the Institutional Review Board (IRB) and will provide the 
reason(s) for the termination or suspension. Study participants will be contacted, as applicable, 
and be informed of changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants 
• Demonstration of efficacy that would warrant stopping 
• Insufficient compliance to protocol requirements 

 
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• Data that are not sufficiently complete and/or evaluable 
• Determination that the primary endpoint has been met 
• Determination of futility 
Study may resume once concerns about safety, protocol compliance, and data quality are 
addressed. 
In terminating the study, the Principal Investigator will assure that adequate consideration is 
given to the protection of the subjects’ interests. 
10.1.3 
Confidentiality and Privacy 
Participant confidentiality and privacy is strictly held in trust by the participating investigators 
and their staff. This confidentiality covers the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior approval by the Penn IRB. 
All research activities will be conducted in as private a setting as possible. 
The study monitor, representatives of the Institutional Review Board (IRB), and other regulatory 
agencies may inspect all documents and records required to be maintained by the investigator, 
including but not limited to, medical records (office, clinic, or hospital) for the participants in 
this study. The study site will permit access to such records. 
The study participant’s contact information will be securely stored at the site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location 
for as long a period as dictated by the reviewing IRB and institutional policies. 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at the Department of Radiation Oncology at Penn 
Medicine. This will not include the participant’s contact or identifying information. Rather, 
individual participants and their research data will be identified by a unique study identification 
number. The study data entry and study management systems used by Department of Radiation 
Oncology research staff will be secured and password protected. At the end of the study, all 
study databases will be de-identified and archived at the Department of Radiation Oncology at 
Penn Medicine. 
The VR system will not collect any patient data. 
10.1.4 
Future Use of Stored Data  
Study data will be de-identified prior to storage for future use. 

 
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10.1.5 
Safety Oversight 
The study PI is responsible for ensuring the ongoing quality and integrity of the research study. 
In addition, this study will be monitored or audited in accordance with Abramson Cancer 
Center’s NCI approved Institutional Data and Safety Monitoring Plan.  
10.1.6 
Clinical Monitoring 
The study PI is responsible for ensuring the ongoing quality and integrity of the research study. 
In addition, this study will be monitored or audited in accordance with Abramson Cancer 
Center’s NCI approved Institutional Data and Safety Monitoring Plan. 
10.1.7 
Data Handling and Record Keeping  
10.1.7.1 
Data Collection and Management Responsibilities  
Source data is all information, original records of clinical findings, observations, or other 
activities in a research study necessary for the reconstruction and evaluation of the study. Source 
data are contained in source documents and may be paper, electronic or a combination of both. 
Examples of these original documents, and data records include: hospital records, clinical and 
office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy 
dispensing records, recorded data from automated instruments, copies or transcriptions certified 
after verification as being accurate and complete, microfiches, photographic negatives, microfilm 
or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, 
and at medico-technical departments involved in the clinical trial. 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the site investigator. The investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. 
All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data and follow ALCOAC standards (attributable, legible, contemporaneous, 
original, accurate, and complete). 
The Principal Investigator will manage and collect electronic survey result data, which will be 
aggregated and deidentified prior to dissemination. Data collected for this study will be analyzed 
and computer-based files containing identifiable information will be stored in the University of 
Pennsylvania RedCap database, a password-protected University of Pennsylvania-managed 
shared drive (\\RadOnc_CAP\), and/or Penn+Box.  
10.1.7.2 
Study Records Retention  
Paper-based records will be kept in a secure location and only be accessible to personnel 
involved in the study. Computer-based files will only be made available to personnel involved in 
the study through the use of access privileges and passwords. Precautions are in place to ensure 

 
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the data is secure by using passwords and encryption, because the research involves web-based 
surveys. 
 
The DHHS regulation (45 CFR 46.115) states that records relating to research conducted or 
supported by any Federal department or agency shall be retained for at least 3 years after 
completion of the research. 
 
Records for this study will be maintained in a secure location with access limited to the 
investigators and the study specific research team for 3 years from the date of full study 
terminations. If necessary, after the first year of termination, records may be moved to an off-site 
secure storage facility. 
10.1.8 
Protocol Deviations 
The PI and the study team should document all scenarios where the protocol is not followed and 
provide, in particular: 
• Who deviated from the protocol 
• What was the deviation 
• When did the deviation occur 
• How did the deviation happen 
• What is the impact of the deviation 
• A root cause analysis of why the deviation occurred 
If the assessment results in a determination that any of the following are potentially affected: 
• having the potential to adversely affect subject safety; OR 
• increases risks to participants; OR 
• adversely affects the integrity of the data; OR 
• violates the rights and welfare of participants, OR 
• affects the subject’s willingness to participate in research.  
• there is a potential for an overall impact on the research that should be shared with the 
IRB for consideration and development of next best steps to address it. 
the deviation should be reported to the University of Pennsylvania IRB and Abramson Cancer 
Center Data and Safety Monitoring Committee (DSMC) per their reporting requirements. 

 
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10.1.9 
Publication and Data Sharing Policy 
The results of this study will be published in the peer-reviewed literature 
10.1.10 
Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who have 
a role in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed 
and managed. Furthermore, persons who have a perceived conflict of interest will be required to 
have such conflicts managed in a way that is appropriate to their participation in the design and 
conduct of this trial. 
10.2 
Protocol Amendment History 
Version 
Date 
Description of Change  
Brief Rationale 
2 
4/18/2024 
-Steven Feigenberg, MD and Jeffrey 
Bradley, MD were added to the protocol 
as sub-investigators. 
-Clarified the screening and informed 
consent process. Screening: clarified that 
patients will be pre-screened by 
inclusion and exclusion criteria prior to 
the day of simulation. Basic 
demographic data will be obtained 
during pre-screening instead of at the 
time of enrollment. 
-Corrected STAI-6 consists of six instead 
of four questions. 
-Adverse events definitions were 
removed. 
-Clarification of discomfort from using 
VR, which is not considered as adverse 
events. 
-Steven Feigenberg, MD and 
Jeffrey Bradley, MD were added to 
the study as sub-investigators.  
-Clarified that patients will be pre-
screened by inclusion and 
exclusion criteria prior to the day of 
simulation. Changed when the 
baseline demographics will be 
collected from the electronic 
medical record. 
- Corrected STAI-6 consists of six 
instead of four questions. 
-Adverse events definitions were 
not relevant to the protocol as we 
are not collecting adverse events.  
-Discomfort needed to be clarified 
as this kind of discomfort will not 
be considered as adverse events.  

 
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Version 
Date 
Description of Change  
Brief Rationale 
3 
10/11/2024 
-Exclusion criteria was changed to 
include the addition of a 6-month 
timeframe for exclusion #2. History of 
epilepsy and seizures was removed from 
exclusion #2 and made as its own 
separate criteria. The clarification of 
exclusion #4, hearing loss “that is not 
treated”. 
- Pre-screening questionnaire was 
modified to reflect the modified 
exclusion criteria. 
We are changing the exclusion 
criteria to give patients who have 
not experienced recent motion 
sickness, car sickness, vertigo, 
migraines, or light sensitivity in the 
last 6 months, an opportunity to 
participate in the study. We will 
continue to exclude patients who 
have history of seizure or epilepsy 
from participating. We clarified the 
exclusion of hearing loss “that is 
not treated”, to be able to include 
patients who wear hearing aids in 
the study. 
4 
9/23/2025 
Updated section 9.3 
We would like to allow for 
additional data to be collected by 
medical record review when 
needed for analysis. Additional 
variables including smoking 
history, smoking pack years, 
primary cancer histology, cancer 
staging, and radiation treatment 
intent (definitive vs palliative) 
 
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4. National Comprehensive Cancer Network. (2022). Distress Management (version 
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https://www.nccn.org/professionals/physician_gls/pdf/distress.pdf. 

 
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5. Meggiolaro, E. Beradri, M., Andritsch, E., Nanni, M., Sirgo, A., Samori, E., Grassi, L. 
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7. Kim, G.M., Kim, S.J., Song, S.K. et al. Prevalence and prognostic implications of 
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Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. 
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The efficacy of mindfulness-based meditation therapy on anxiety, depression, and 
spirituality in Japanese patients with cancer. Journal of palliative medicine, 12(12), 1091-
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V, Moscoso M, Budhrani-Shani P, Miladinovic B, Jacobsen PB, Cox CE, Goodman M, 
Kip KE. Examination of Broad Symptom Improvement Resulting From Mindfulness-
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May 31.  
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Meditation Program on Quality of Life in Cancer Outpatients: An Exploratory Study. 
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2017 Feb 1.  
13. Oberoi S, Yang J, Woodgate RL, Niraula S, Banerji S, Israels SJ, Altman G, Beattie S, 
Rabbani R, Askin N, Gupta A, Sung L, Abou-Setta AM, Zarychanski R. Association of 
Mindfulness-Based Interventions With Anxiety Severity in Adults With Cancer: A 
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15. Reynolds LM, Cavadino A, Chin S, Little Z, Akroyd A, Tennant G, Dobson R, Broom R, 
Gautier A. The benefits and acceptability of virtual reality interventions for women with 
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McKelvey K, Vrahas M, Danovitch I, Spiegel B. Home-based virtual reality for chronic 
pain: protocol for an NIH-supported randomised-controlled trial. BMJ Open. 2021 Jun 
15;11(6):e050545 
18. Fleiss, J. L., Levin, B., Paik, M.C. 2003. Statistical Methods for Rates and Proportions. 
Third Edition. John Wiley &  Sons. New York. 
19. Newcombe, R. G. 1998. 'Two-Sided Confidence Intervals for the Single Proportion: 
Comparison of Seven Methods.' Statistics in Medicine, 17, pp. 857-872. 
20. Vodermaier A, Linden W, Siu C. Screening for emotional distress in cancer patients: a 
systematic review of assessment instruments. J Natl Cancer Inst. 2009 Nov 
4;101(21):1464-88. doi: 10.1093/jnci/djp336. 
21. Mackenzie LJ, Carey ML, Sanson-Fisher RW, D'Este CA. Psychological distress in 
cancer patients undergoing radiation therapy treatment. Support Care Cancer. 2013 
Apr;21(4):1043-51 
22. Zigmond, A. S., & Snaith, R. P. (1983). The hospital anxiety and depression scale. Acta 
psychiatrica scandinavica, 67(6), 361-370. 
23. Spielberger, C. D. (1970). Manual for the state-trait anxietry, inventory. Consulting 
Psychologist. 
24. Marteau, T. M., & Bekker, H. (1992). The development of a six‐item short‐form of the 
state scale of the Spielberger State—Trait Anxiety Inventory (STAI). British journal of 
clinical Psychology, 31(3), 301-306.Melissa Burns, Rachel Campbell, Sofie French, 
Haryana M. Dhillon, Phyllis N. Butow, Aaron Pritchard, Purnima Sundaresan, 
25. Burns, M., Campbell, R., French, S., Dhillon, H. M., Butow, P. N., Pritchard, A., & 
Sundaresan, P. (2022). Trajectory of anxiety related to radiation therapy mask 
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ability to detect this anxiety.“Anxiety during radiation therapy with mask”. Advances in 
Radiation Oncology, 100967. 
12 APPENDIX  
12.1 
 Schedule of Activities (SoA) 
 

 
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Procedures 
Day -30 to 1 
Enrollment/Baseline 
Visit 1, Day 1 
Screening (including pre-screening 
questionnaire) 
X 
X 
Informed consent 
 
X 
Demographics 
X 
 
HADS Questionnaire  
 
X 
STAI-Short form 
 
X 
VR intervention 
 
X 
Usability Survey 
 
X 

 
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12.2 
Questionnaires 
Pre-Screening Questionnaire 
Have you experienced motion sickness, car sickness, migraines, vertigo or light sensitivity 
within the last 6 months? 
‘Yes’ will screen patients out of the study. 
[ ] Yes 
[ ] No 
 
 
 
Do you have a history of  epilepsy or seizures? 
‘Yes’ will screen patients out of the study. 
[ ] Yes 
[ ] No 
 
Are you currently experiencing nausea, dizziness, lightheadedness or vomited in the last 24 
hours? 
‘Yes’ will screen patients out of the study. 
[ ] Yes 
[ ] No 
 
 
Hospital Anxiety and Depression Scale (HADS)- pre-intervention only 
Choose the answer that is closest to how you have been feeling in the past week. Don’t take too 
long over your replies: your immediate is best. 
1. I feel tense or ‘wound up’: 
[ ] Most of the time 
[ ] A lot of the time 
[ ] From time to time 
[ ] Not at all 
 
2. I still enjoy the things I used to enjoy: 
[ ] Definitely as much 
[ ] Not quite so much 
[ ] Only a little 
[ ] Hardly at all 

 
Protocol IRB# 854756 –  
Virtual Reality to Promote Relaxation Prior to Radiation Feasibility 
 
Confidential and Proprietary Information of the University of Pennsylvania 
 
 
3. I get a sort of frightened feeling as if something awful is about to happen: 
[ ] Very definitely and quite badly 
[ ] Yes, but not too badly 
[ ] A little, but it doesn’t worry me 
[ ] Not at all 
 
4. I can laugh and see the funny side of things: 
[ ] As much as I always could 
[ ] Not quite so much now 
[ ] Definitely not so much now 
[ ] Not at all 
 
5. Worrying thoughts go through my mind: 
[ ] A great deal of the time 
[ ] A lot of the time 
[ ] From time to time, but not too often 
[ ] Only occasionally 
 
6. I feel cheerful: 
[ ] Not at all 
[ ] Not often 
[ ] Sometimes 
[ ] Most of the time 
 
7. I can sit at ease and feel relaxed: 
[ ] Definitely 
[ ] Usually 
[ ] Not often 
[ ] Not at all 
 
8. I feel as if I am slowed down: 
[ ] Nearly all the time 
[ ] Very often 
[ ] Sometimes 
[ ] Not at all 
 
9. I get a sort of frightened feeling like ‘butterflies’ in the stomach: 
[ ] Not at all 
[ ] Occasionally 
[ ] Quite often 

 
Protocol IRB# 854756 –  
Virtual Reality to Promote Relaxation Prior to Radiation Feasibility 
 
Confidential and Proprietary Information of the University of Pennsylvania 
 
[ ] Very often 
 
10. I have lost interest in my appearance: 
[ ] Definitely 
[ ] I don’t take as much care as I should 
[ ] I may not take quite as much care 
[ ] I take just as much care as ever 
 
11. I feel restless as I have to be on the move: 
[ ] Very much indeed 
[ ] Quite a lot 
[ ] Not very much 
[ ] Not at all 
 
12. I look forward with enjoyment to things: 
[ ] As much as I ever did 
[ ] Rather less than I used to 
[ ] Definitely less than I used to  
[ ] Hardly at all 
 
13. I get sudden feelings of panic: 
[ ] Very often indeed 
[ ] Quite often 
[ ] Not very often 
[ ] Not at all 
 
14. I can enjoy a good book or radio or TV program: 
[ ] Often 
[ ] Sometimes 
[ ] Not often 
[ ] Very seldom 
 
 
The State-Trait Anxiety Inventory (STAI) – Administered pre- and post-intervention 
 
A number of statements which people have used to describe themselves are given below. Read 
each statement and then circle the most appropriate number to the right of the statement to 
indicate how you feel right now, at this moment. There are no right or wrong answers. Do not 
spend too much time on any one statement but give the answer which seems to describe your 
present feelings best. 

 
Protocol IRB# 854756 –  
Virtual Reality to Promote Relaxation Prior to Radiation Feasibility 
 
Confidential and Proprietary Information of the University of Pennsylvania 
 
 
 
 
Not at all 
Somewhat 
Moderately 
Very Much 
1. I feel calm 
1 
2 
3 
4 
2. I am tense 
1 
2 
3 
4 
3. I feel upset 
1 
2 
3 
4 
4. I am relaxed 
1 
2 
3 
4 
5. I feel content 
1 
2 
3 
4 
6. I am worried 
1 
2 
3 
4 
 
 
Usability – administered post-intervention only 
 
Prior to your participation in this study, how much experience do you have using virtual reality? 
[ ] None at all 
[ ] Some experience 
[ ] A lot of experience 
 
 
The virtual reality program kept my attention 
[ ] Agree 
[ ] Neutral 
[ ] Disagree 
 
The virtual reality program was relaxing 
[ ] Agree 
[ ] Neutral 
[ ] Disagree 
 
The virtual reality program was easy to use 
[ ] Agree 
[ ] Neutral 
[ ] Disagree 
 
The headset was comfortable 
[ ] Agree 

 
Protocol IRB# 854756 –  
Virtual Reality to Promote Relaxation Prior to Radiation Feasibility 
 
Confidential and Proprietary Information of the University of Pennsylvania 
 
[ ] Neutral 
[ ] Disagree 
 
The virtual reality program helped me cope with my cancer treatment 
[ ] Agree 
[ ] Neutral 
[ ] Disagree 
 
The virtual reality program lowered my stress level 
[ ] Agree 
[ ] Neutral 
[ ] Disagree 
 
The virtual reality program distracted me from my cancer treatment 
[ ] Agree 
[ ] Neutral 
[ ] Disagree 
 
How would you rate your overall experience using the virtual reality program? 
[ ] Satisfied 
[ ] Neither satisfied or dissatisfied 
[ ] Dissatisfied 
 
 
Would you use this virtual reality program again? 
[ ] Yes 
[ ] Maybe 
[ ] No 
 
Would you recommend this program to other patients? 
[ ] Yes 
[ ] Maybe 
[ ] No 
 
Did you find the breathing techniques described in the virtual reality program helpful? 
[ ] Yes 
[ ] Maybe 
[ ] No 
 
In terms of length, the virtual reality program was:  
[ ] Too long 

 
Protocol IRB# 854756 –  
Virtual Reality to Promote Relaxation Prior to Radiation Feasibility 
 
Confidential and Proprietary Information of the University of Pennsylvania 
 
[ ] Just about right 
[ ] Too short 
 
What did you like most about the virtual reality program? 
______________________________________________________________________________
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 What did you like least about the virtual reality program? 
______________________________________________________________________________
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Did you find anything problematic in the virtual reality program? 
______________________________________________________________________________
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