RecruitingNot ApplicableNCT06248216

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


Sponsor

University of Maryland, Baltimore

Enrollment

30 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

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, depression, and anxiety in participants suffering from chronic cancer symptoms following cancer treatments.


Eligibility

Min Age: 18 YearsMax Age: 88 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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

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Interventions

DEVICERelievrx

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.

OTHERAudio Mp4

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


Locations(2)

Luana Colloca

Baltimore, Maryland, United States

University of Maryland

Baltimore, Maryland, United States

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NCT06248216


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