Cognitive Behavioral Theory-assisted Virtual Reality for Chronic CANcer Pain (VR-CAN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute
About this trial
While chronic cancer pain affecting as many as 75% of patients is typically addressed using pharmacologic interventions, experts and patients alike support maximizing any relevant non-pharmacologic interventions as well, such as cognitive behavioral therapy. Virtual reality, a novel technology that can temporarily immerse users in a calm, pleasant environment, has been increasingly shown to facilitate improvement in different acute and chronic pain syndromes by providing distraction from pain and lowering pain sensation. To address the significant needs of patients living with chronic cancer pain, we aim to develop and pilot test a prototype device that will leverage cognitive behavioral therapy principles to deliver a novel virtual reality pain therapy. The investigators will do this through the following steps:
Step 1. Develop and refine a CBT-assisted VR prototype for patients with chronic cancer pain (VR-CAN).
Step 2. Conduct a randomized controlled trial to examine the feasibility, acceptability, usability, safety, and initial clinical impact of the developed VR-CAN prototype compared to a tablet-based two-dimensional video control group.
Step 3. Collect and evaluate qualitative post-intervention data on VR-CAN participants' preferences, thoughts, and feelings about the VR-CAN technology and protocol to optimize for a future, larger, fully powered randomized controlled trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age at least 18 years old
cancer diagnosis, undergoing treatment
chronic cancer pain (i.e., cancer pain at least 3 months duration) with baseline pain severity at least 4/10 (where 0=no pain, 10=worst pain)
Disqualifiers
intractable nausea/vomiting, motion sickness, seizures/epilepsy, and/or cranial structures/abnormalities preventing VR headset use
moderate-severe pain of non-cancer etiology
enrolled in another pain study
unable to complete survey measures or interviews in English or Spanish
Trial design
Design model
Parallel
Treatments tested in this trial
VR-CAN prototype chronic cancer pain therapy -- virtual reality program delivering CBT for chronic cancer pain management
DeviceVR-CAN participants will be instructed to use the prototype VR-CAN software on the VR device at home daily for two weeks, at least 10 minutes per session, beginning the day after enrollment.
Active Control -- two-dimensional tablet-delivered intervention
DeviceTablet-based active control participants will follow the same prescription as the experimental arm (i.e., using assigned technology \>10 min/daily for two weeks at home), except they will view a two-dimensional, non-CBT skills version using a tablet device.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Virtual reality delivered behavioral skills for pain managementExperimental treatment 1 intervention
Group B: Tablet-based delivery of behavioral skills for pain managementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of device use as assigned
Protocol adherence (completion of assigned intervention).
Time frame
From enrollment to study completion (14 days)Secondary outcomes
1
Acceptability
Client Satisfaction Questionnaire (CSQ)
Time frame
From enrollment to study completion (14 days)2
Usability
System Usability Scale (SUS)
Time frame
From enrollment to study completion (14 days)3
Safety of intervention
Participants' self-report of side effects
Time frame
From enrollment to study completion (14 days)4
Pain interference
Pain interference-Short Form (SF)
Time frame
From enrollment to study completion (14 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medstar Health Research Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov