Virtual Reality Therapy for Cancer-Treatment Associated Symptoms

Cancer Clinical Trial

Official title:

Implementation of an At-Home Multimodal Integrative Therapy Via Virtual Reality for Patients With Cancer-Treatment Associated Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06248216
• Other study ID #: HP-00108489
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We propose an innovative approach to symptom management in cancer patients following cancer treatments, utilizing a Multimodal Integrative Therapy (MIT) delivered via Virtual Reality (VR) program, authorized by the US Food and Drug Administration for in-home use. Our primary goal is to generate pilot data on the effects of MIT-VR program on pain, fatigue, sleep, and anxiety in participants suffering from chronic cancer symptoms following cancer treatments.

Description:

All of the study procedures will be completed over the course of one month, during which participants will make four visits or phone calls (one virtual enrollment visit followed by 3 virtual follow up visits/phone calls). Participants will be randomly assigned in a 1:1 fashion to one of two different interventions: virtual reality or Mp4 audio. At home, participants will engage in their assigned intervention 5x throughout the week using the provided device and fill out required questionnaires. In the virtual reality intervention, participants will complete the scheduled educational module five times in the week of the intervention. This VR is assisting users in using immersive reality to reduce pain, learning cognitive and behavior self-coping skills and retraining the pain pathways. There are several sessions, which will be delivered using an all-in-one head-mounted display. Each session varies in duration approximately from 3 to 15 minutes. Similarly, in the audio intervention, participants will complete the scheduled module 5 times a week of the intervention. The content is similar to that of the VR, which will be delivered by the audio player. Each session varies in duration approximately from 3 to 15 minutes. The first visit is an enrollment visit. The rest of the 3 follow-up visits will take place throughout the month-long intervention period. For the enrollment visit, the participant will first complete a battery of baseline surveys. They will also receive instructions about the intervention and go through the first module of the intervention to which he or she is assigned. A member of the research team will stay with the participant while the participant completes the module to ensure the proper functioning of the device and will answer any questions that may arise. The team member will also guide the participant on how to use the device. During the 3 follow up visits, we will address questions and issues that arise for participants to ensure compliance. Participants will return the provided devices upon completing the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

• Adults ages 18-88
• Cancer diagnosis (histology verified)
• Had surgical intervention, completed chemotherapy or radiation for therapeutic purposes ->3 months since last cancer treatment
• Documented symptoms of cancer or cancer therapy including at least one of the following: pain, anxiety, sleep difficulty, fatigue, neuropathy
• english speaker (written and spoken)

Exclusion Criteria:

• Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years
• Any personal (or family first degree) history of mania, schizophrenia, or other psychoses
• Diagnosis of chronic pain, neuropathy, fatigue, sleep or anxiety disorder prior to cancer diagnosis
• Current Hospice or palliative care only recipients
• Color-blindness
• Impaired or uncorrected hearing
• Lifetime alcohol/drug dependence or alcohol/drug abuse in past 3 months
• Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection)
• Known history of severe motion sickness
• Pregnancy or breast feeding

Related Conditions & MeSH terms

• Cancer
• Cancer Pain
• Virtual Reality

Intervention

Device:
• Relievrx
The RelieVRx program is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.

Other:
• Audio Mp4
Audio Mp4 modules ranging from 3-15 minutes with guided meditation.

Locations

Country	Name	City	State
United States	Luana Colloca	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (12)

Bedford T, Adediran T, Haycock NR, Mullins CD, Medeiros M, Wright T, Curatolo M, Hamlin L, Colloca L. Patient and Provider Acceptability of a Patient Preauthorized Concealed Opioid Reduction. Pain Med. 2021 Jul 25;22(7):1651-1659. doi: 10.1093/pm/pnaa454. — View Citation

Brea-Gomez B, Torres-Sanchez I, Ortiz-Rubio A, Calvache-Mateo A, Cabrera-Martos I, Lopez-Lopez L, Valenza MC. Virtual Reality in the Treatment of Adults with Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Int J Environ Res Public Health. 2021 Nov 11;18(22):11806. doi: 10.3390/ijerph182211806. — View Citation

Darnall BD, Krishnamurthy P, Tsuei J, Minor JD. Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study. JMIR Form Res. 2020 Jul 7;4(7):e17293. doi: 10.2196/17293. — View Citation

Garcia L, Birckhead B, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Castro C, Maddox R, Maddox T, Darnall BD. Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial. J Med Internet Res. 2022 May 25;24(5):e37480. doi: 10.2196/37480. Erratum In: J Med Internet Res. 2022 Jun 8;24(6):e40038. — View Citation

Garcia LM, Birckhead BJ, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Maddox T, Darnall BD. Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. J Pain. 2022 May;23(5):822-840. doi: 10.1016/j.jpain.2021.12.002. Epub 2021 Dec 11. — View Citation

Garcia LM, Birckhead BJ, Krishnamurthy P, Sackman J, Mackey IG, Louis RG, Salmasi V, Maddox T, Darnall BD. An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19. J Med Internet Res. 2021 Feb 22;23(2):e26292. doi: 10.2196/26292. — View Citation

Garcia LM, Darnall BD, Krishnamurthy P, Mackey IG, Sackman J, Louis RG, Maddox T, Birckhead BJ. Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 19;10(1):e25291. doi: 10.2196/25291. Erratum In: JMIR Res Protoc. 2021 Feb 12;10(2):e27652. — View Citation

Grassini S. Virtual Reality Assisted Non-Pharmacological Treatments in Chronic Pain Management: A Systematic Review and Quantitative Meta-Analysis. Int J Environ Res Public Health. 2022 Mar 29;19(7):4071. doi: 10.3390/ijerph19074071. — View Citation

Kelleher SA, Fisher HM, Winger JG, Miller SN, Amaden GH, Somers TJ, Colloca L, Uronis HE, Keefe FJ. Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability. Palliat Support Care. 2022 Aug;20(4):471-481. doi: 10.1017/S1478951521002017. — View Citation

Maddox T, Sparks C, Oldstone L, Maddox R, Ffrench K, Garcia H, Krishnamurthy P, Okhotin D, Garcia LM, Birckhead BJ, Sackman J, Mackey I, Louis R, Salmasi V, Oyao A, Darnall BD. Durable chronic low back pain reductions up to 24 months after treatment for an accessible, 8-week, in-home behavioral skills-based virtual reality program: a randomized controlled trial. Pain Med. 2023 Oct 3;24(10):1200-1203. doi: 10.1093/pm/pnad070. No abstract available. — View Citation

Tas FQ, van Eijk CAM, Staals LM, Legerstee JS, Dierckx B. Virtual reality in pediatrics, effects on pain and anxiety: A systematic review and meta-analysis update. Paediatr Anaesth. 2022 Dec;32(12):1292-1304. doi: 10.1111/pan.14546. Epub 2022 Sep 1. — View Citation

Zeng Y, Zhang JE, Cheng ASK, Cheng H, Wefel JS. Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419871108. doi: 10.1177/1534735419871108. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VR effect on perceived pain	During daily intervention sessions (VR), participants will be required to do a pre-intervention and post-intervention survey regarding their pain (REDCAP visual analog pain survey). The post-surveys will be compared to the pre-surveys to determine VR's effect on participant pain. The surveys incorporate the Visual Analogue Scale (VAS) from 0-100, 0 being no pain experienced and 100 being the most pain experienced.	Baseline to end of intervention (4 weeks)
Primary	VR effect on perceived fatigue	Participants will take the PROMIS fatigue prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine VR's effect on participant fatigue. The PROMIS fatigue scale ranges from 0-50, 0 being no fatigue and 50 meaning the most fatigue.	Baseline to end of intervention (4 weeks)
Primary	VR effect on perceived anxiety	Participants will take the PROMIS anxiety prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine VR's effect on participant anxiety. The PROMIS anxiety scale ranges from 7-35, 7 being the least anxious and 35 being the most anxious.	Baseline to end of intervention (4 weeks)
Primary	Audio effect on perceived pain	During daily intervention sessions (audio), participants will be required to do a pre-intervention and post-intervention survey regarding their pain (REDCAP visual analog pain survey). The post-surveys will be compared to the pre-surveys to determine audio MP4's effect on participant pain. The surveys incorporate the Visual Analogue Scale (VAS) from 0-100, 0 being no pain experienced and 100 being the most pain experienced.	Baseline to end of intervention (4 weeks)
Primary	Audio effect on perceived fatigue	Participants will take the PROMIS fatigue prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine audio MP4's effect on participant fatigue. The PROMIS fatigue scale ranges from 0-50, 0 being no fatigue and 50 meaning the most fatigue.	Baseline to end of intervention (4 weeks)
Primary	Audio effect on perceived anxiety	Participants will take the PROMIS anxiety prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine audio MP4's effect on participant anxiety. The PROMIS anxiety scale ranges from 7-35, 7 being the least anxious and 35 being the most anxious.	Baseline to end of intervention (4 weeks)
Primary	Difference in effect of VR vs audio MP4 intervention on pain	Scores from the daily pre and post pain surveys of each group with be compared to examine whether audio or VR had a greater impact on pain. The surveys incorporate the Visual Analogue Scale (VAS) from 0-100, 0 being no pain experienced and 100 being the most pain experienced.	Baseline to end of intervention (4 weeks)
Primary	Difference in effect of VR vs audio MP4 intervention on fatigue	Scores from the baseline and weekly PROMIS fatigue surveys will be compared between VR and audio MP4 groups to determine if there was a differential effect on fatigue. The PROMIS fatigue scale ranges from 0-50, 0 being no fatigue and 50 meaning the most fatigue.	Baseline to end of intervention (4 weeks)
Primary	Difference in effect of VR vs audio MP4 intervention on anxiety	Scores from the baseline and weekly PROMIS anxiety surveys will be compared between VR and audio MP4 groups to determine if there was a differential effect on anxiety. The PROMIS anxiety scale ranges from 7-35, 7 being the least anxious and 35 being the most anxious.	Baseline to end of intervention (4 weeks)
Primary	VR effect on perceived depression	Participants will take the PROMIS depression prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine VR's effect on participant depression. The PROMIS depression scale ranges from 4-20, 4 being the least depressed and 20 being the most depressed.	Baseline to end of intervention (4 weeks)
Primary	Audio effect on perceived depression	Participants will take the PROMIS depression prior to intervention, and weekly throughout 4 week study period. Each follow-up survey will be compared to the baseline survey to determine audio MP4's effect on participant depression. The PROMIS depression scale ranges from 4-20, 4 being the least depressed and 20 being the most depressed.	Baseline to end of intervention (4 weeks)
Primary	Difference in effect of VR vs audio MP4 intervention on depression	Scores from the baseline and weekly PROMIS depression surveys will be compared between VR and audio MP4 groups to determine if there was a differential effect on depression. The PROMIS depression scale ranges from 4-20, 4 being the least depressed and 20 being the most depressed.	Baseline to end of intervention (4 weeks)