Virtual Reality for Outpatient Cancer Pain Management

Virtual Reality for Outpatient Cancer Pain Management: a Dosing Study

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Cancer Pain
• Intervention / Treatment: Device: Virtual reality experience for 10 minutes

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual reality (VR) dosing arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Pain Score	Participant reports average pain (Likert scale 0-10, 0=pain, 10=worst pain) over last 7 days; results report the average change in self-reported pain score per study week, from baseline (Study day 0) to each subsequent measurement (measured on Study day 7 (week 1), Study day 14 (week 2), Study day 21(week 3))	3 weeks (baseline to Study day 21)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Pain Interference Short Form	Participant completes PROMIS measure of pain interference over last 7 days; PROMIS Pain Interference SF has 6 questions, each with possible scores 1 to 5, making a possible score range between 6 and 30 points - 30 points is the highest level of total pain interference, 6 points is the lowest level of total pain interference. These results report the average change in total Pain Interference SF score per study week, from baseline (Study day 0) to each subsequent measurement (measured on Study day 7 (week 1), Study day 14 (week 2), Study day 21(week 3))	3 weeks (baseline to Study day 21)
Number of As-needed Opioid Doses Per Day	Participant reports how many as-needed opioid doses used in last 7 days (only for participants prescribed as-needed opioids); results report average number of as-needed opioid doses per day for each study week	3 weeks (baseline day 0 to Study day 21)
Satisfaction With Overall Pain Management	Participant reports satisfaction with pain management over last 7 days (Likert scale, 0=very unsatisfied, 10=highly satisfied); results report the average change in score of overall satisfaction in pain management per study week, from baseline (Study day 0) to each subsequent measurement (measured on Study day 7 (week 1), Study day 14 (week 2), Study day 21(week 3))	3 weeks (baseline to 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)	3 weeks (baseline to 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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: National Institute of Nursing Research (NINR)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: STUDY00004928; U2CNR014637 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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