Virtual Reality for Outpatient Cancer Pain Management

Study Overview
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Brief Summary
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This is a non-randomized, unblinded dose-titration study to evaluate different doses of virtual reality to impact moderate-to-severe pain in patients living with cancer. After consenting to participate, in addition to usual pharmacologic pain management, participants will receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participants.

Detailed Description
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The purpose of this a non-randomized, unblinded dose-titration study to evaluate the impact of virtual reality therapy on mitigating moderate to severe pain in outpatients living with cancer. Outpatients receiving cancer care at the Washington Cancer Institute (Washington, DC) will be considered for enrollment in this study if able to provide consent, at least 18 years old, and report moderate-severe pain (at least 4 out of 10 where pain is rated on a Likert scale between zero and 10) in the previous 7 days as a result of either cancer or cancer treatment. Palliative care consultation and/or referral to palliative care is not required for eligibility or participation. Additionally, participation will not be limited by whether subjects are receiving specific cancer-directed therapies at the time of enrollment. Subjects will be excluded if they already use VR for personal use, have intractable nausea/vomiting, history of motion sickness, history of seizures or epilepsy, have cranial structure abnormalities that prevent use of VR headset, or are currently enrolled in a palliative care or pain management study. Subjects will also be excluded if they have limited vision or vision defects that are not corrected with prescription eyeglasses, or if participants are unable or do not wish to wear required corrective eyeglasses with the VR headset. Informed consent will be conducted before enrolling each patient. This is a non-randomized, unblinded dose-titration study. After consenting to participate, in addition to usual pharmacologic pain management, participants will receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participants. Because of the nature of the compared interventions, subjects and researchers cannot be blinded to intervention. Our primary outcome measure will determine the impact of VR on self-reported pain score in the last week (numeric rating scale, collected weekly). Self-reported pain experience remains the standard for clinical pain research. Secondary outcomes will measure pain interference (PROMIS Pain Interference Short Form, collected weekly), as-needed opioid use for patients taking opioid analgesics at the time of enrollment (self-reported using medication administration form), satisfaction with VR intervention and overall pain management (collected weekly), and survey of preferences for VR thematic content (collected after Week 4). Following consent, subjects will complete baseline outcome assessments including self-reported pain score in the last week, the PROMIS Pain Interference Short Form, as-needed opioid use in the last week if applicable, and satisfaction with overall pain management. Subjects will then be provided with a VR headset and paired Touch controllers to bring home for the duration of the study and instructions on the frequency of use for each week. A member of the research will educate the patient on the technology and assure comfort with use. The research study coordinator will contact patients by phone at the end of each week to confirm dates and duration of use as specified by the study protocol, collect self-reported pain score in the last week, the PROMIS Pain Interference Short Form, as-needed opioid use in the last week if applicable, and satisfaction with the VR intervention and overall pain management. Additionally, participants will be surveyed on preferences for VR thematic content at the end of Week 3.

Official Title
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Virtual Reality for Outpatient Cancer Pain Management: a Dosing Study

Conditions
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Cancer, Cancer Pain

Intervention / Treatment
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* Device: Virtual reality experience for 10 minutes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Have diagnosis of cancer (any type) Report moderate-severe pain related to cancer or cancer treatment at baseline Able to provide consent Exclusion Criteria: Already use VR for personal use Have intractable nausea/vomiting, history of motion sickness, history of seizures or epilepsy Have cranial structure abnormalities that prevent use of VR headset Currently enrolled in a palliative care or pain management study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality (VR) dosing arm<br>All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. | Device: Virtual reality experience for 10 minutes<br>* Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported pain score from baseline (Study day 0) to each subsequent measurement (measured on Study day 7, Study day 14, Study day 21) | Participant reports average pain (Likert scale 0-10, 0=pain, 10=worst pain) over last 7 days | A) baseline (study day 0), B) study day 7, C) study day 14, D) study day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS Pain Interference Short Form from baseline (Study day 0) to each subsequent measurement (measured on Study day 7, Study day 14, Study day 21) | Participant completes PROMIS measure of pain interference over last 7 days | A) baseline (study day 0), B) study day 7, C) study day 14, D) study day 21 | 
| Change in as-needed opioid doses from baseline (Study day 0) to each subsequent measurement (measured on Study day 7, Study day 14, Study day 21) | Participant reports how many as-needed opioid doses used in last 7 days (only for participants prescribed as-needed opioids) | A) baseline (study day 0), B) study day 7, C) study day 14, D) study day 21 | 
| Change in satisfaction with overall pain management from baseline (Study day 0) to each subsequent measurement (measured on Study day 7, Study day 14, Study day 21) | Participant reports satisfaction with pain management over last 7 days (Likert scale, 0=very unsatisfied, 10=highly satisfied) | A) baseline (study day 0), B) study day 7, C) study day 14, D) study day 21 | 
| Satisfaction with virtual reality intervention over previous 7 days | Participant reports satisfaction with virtual reality intervention over last 7 days (Likert scale, 0=very unsatisfied, 10=highly satisfied) | A) study day 7, B) study day 14, C) study day 21 | 
| Preferences for virtual reality thematic content (measured once, with no comparison) | Participant chooses preferred visual thematic content (as many as preferred) from photos of different images (e.g. beachscape, rain forest, luxury auto, monastery, etc.) | Study day 21 |