Clinical trial · Interventional
Virtual Reality Therapy for Cancer-Treatment Associated Symptoms
Implementation of an At-Home Multimodal Integrative Therapy Via Virtual Reality for Patients With Cancer-Treatment Associated Symptoms
NCT06248216CI-TRIAL-00109826recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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, depression, and anxiety in participants suffering from chronic cancer symptoms following cancer treatments.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer Pain | — | UNRESOLVED | — |
| Virtual Reality | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Audio Mp4 | Other | — | UNRESOLVED |
| Relievrx | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Virtual reality arm
- description
- 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.
- interventionNames
- Device: Relievrx
- type
- PLACEBO_COMPARATOR
- label
- Audio Mp4 arm
- description
- 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.
- interventionNames
- Other: Audio Mp4
Primary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 88 Years
Show eligibility criteria text
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, but participants currently undergoing endocrine or immunotherapy treatments are permissible * 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 and treatment 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
References
Publications (12)
- BACKGROUNDBrea-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. PMID 34831562
- BACKGROUNDGrassini 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. PMID 35409751
- BACKGROUNDTas 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. PMID 35993398
- BACKGROUNDBedford 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. PMID 33674821
- BACKGROUNDDarnall 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. PMID 32374272
- BACKGROUNDGarcia 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. PMID 33464215
- BACKGROUNDGarcia 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.