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| ID | Type | Description | Link |
|---|---|---|---|
| U2CNR014637 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality (VR) dosing arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality experience for 10 minutes | Device | 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. |
| 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) |
| 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)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40653577 | Derived | Groninger H, Violanti D, McPherson ML, Hopkins K, Carr AL, Hurtado M, Mete M. Virtual reality for outpatient management of cancer pain: a pilot dosing study. Support Care Cancer. 2025 Jul 14;33(8):690. doi: 10.1007/s00520-025-09723-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)) | Posted | Mean | Standard Error | score on a scale, measured each week | 3 weeks (baseline to Study day 21) |
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Each participant was enrolled and followed by the study coordinator for a maximum period of 3 weeks (from enrollment and baseline measures to final measure collection). Because virtual reality has never been shown to have adverse events that last longer than the duration of the virtual reality device use, this time frame was most appropriate for adverse event data collection.
Adverse events were first collected by the study coordinator during usual study processes and participant follow up and were each reviewed by the PI.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized | Infections and infestations | Non-systematic Assessment | Participant admitted to hospital for management of infection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment | Participant experienced brief general headache during VR, headache stopped after patient stopped VR |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hunter Groninger | MedStar Health Research Institute | 202-877-7445 | hunter.groninger@medstar.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2022 | Nov 18, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2022 | Nov 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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)) | Posted | Mean | Standard Error | score on a scale, measured each week | 3 weeks (baseline to Study day 21) |
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| Secondary | 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 | Patients taking as needed opioids who completed all three study weeks | Posted | Mean | Standard Deviation | prn doses per day | 3 weeks (baseline day 0 to Study day 21) |
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| Secondary | 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)) | Posted | Mean | Standard Error | score on a scale, measured each week | 3 weeks (baseline to Study day 21) |
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| Secondary | 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) | Patients who completed all three weeks of study completed this survey question | Posted | Mean | Standard Error | score on a scale | 3 weeks (baseline to Study day 21) |
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| Secondary | 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.) | Participants who completed all three weeks of study period | Posted | Count of Participants | Participants | Study day 21 |
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| 1 |
| 33 |
| 2 |
| 33 |
| 2 |
| 33 |
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| Surgery | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Patient required hospitalization and surgery for management of cancer |
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| Dizziness | Nervous system disorders | Non-systematic Assessment | Participant experienced brief dizziness while using VR, stopped after participant stopped using VR |
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