Menu
Recruiting NCT07228377

Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) Study

No phase Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: virtual reality pain therapy.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) - Feasibility, Acceptability, Usability Testing of a Novel Intervention

Overview

Patients living with cancer commonly have chronic pain due to the disease or to cancer treatments. Virtual reality, a new technology that immerses the user in pleasant, diverting, and exciting virtual environments, may lower chronic cancer pain to improve quality of life and complement need for pain medications like opioids. The investigators aim to learn from patients about the experience of cancer pain, develop a virtual reality prototype specific to cancer pain management, and test the feasibility and acceptability of this technology to improve the cancer pain experience.

Detailed description

Patients living with cancer commonly experience chronic pain, defined as pain lasting at least three months. While cancer pain management has traditionally focused on pharmacologic therapies, particularly opioids, pain experts, clinical guidelines, and patients living with cancer increasingly support the use of non-pharmacologic therapies (including mind-body modalities such as distraction, mindfulness, and cognitive behavioral therapy) to mitigate pain and potentially reduce pain medication needs. Virtual reality (VR), a rapidly evolving technology that immerses the user in pleasant, virtual environments, has been shown to lower different forms of acute and chronic pain syndromes, but has not been developed specifically to improve chronic cancer pain. The long-term goal of the investigators is to develop and disseminate a patient-centered, patient-driven VR intervention that significantly improves the chronic cancer pain experience. Towards this end, they propose a multi-phase project involving active patient stakeholder input and an iterative design process that will achieve the following Specific Aims: Aim 1 - to identify patient perceptions around chronic cancer pain experiences and management strategies; Aim 2 - to develop a highly feasible, acceptable, usable, safe VR prototype enabling patient-directed management of cancer pain; Aim 3 - to conduct a trial to assess prototype feasibility, acceptability, usability, and safety. Completion of this project will lead towards development of a scalable VR intervention to mitigate pain that has potential to dramatically improve quality of life and clinical outcomes in patients living with chronic cancer pain.

Interventions

  • Behavioral virtual reality pain therapy
    DISCOVR virtual reality pain therapy

Primary outcome measures

  • Intervention feasibility [Time frame: From enrollment to end of treatment at 7 days]
Secondary outcome measures (2)
  • Acceptability [Time frame: Collected at end of 7 days participation]
  • Usability [Time frame: Collected at end of 7 day participation]

Eligibility criteria

Inclusion criteria

  • age ≥18 years old
  • living with active cancer diagnosis (any solid tumor type)
  • report chronic cancer pain (≥3 months) with baseline severity moderate-severe (i.e., self-report pain score (SRPS) ≥4/10, where 0=no pain, 10=worst pain)
  • prescribed chronic opioid therapies (may be long-acting formulations, short-acting formulations, or both)

Exclusion criteria

  • history of intractable nausea/vomiting, motion sickness, seizures/epilepsy, and/or cranial structure abnormalities preventing VR headset use
  • moderate-severe pain of non-cancer etiology (e.g., chronic lumbago)
  • enrolled in another pain study
  • unable to complete surveys in English or Spanish.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center — Washington D.C.

Identifiers

NCT: NCT07228377 · STUDY00010075 · 1R43CA302795-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗