N/A
N=20
Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04069702 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Feasibility, Assessed by Examining Number of Participants Accrued — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VR Blue (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility, Assessed by Examining Number of Participants Accrued |
20 | — |
| PRIMARY Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol |
20 | — |
| PRIMARY Feasibility, Assessed by Number of Participants With Completed Data |
20 | — |
| PRIMARY Acceptability Using the Client Satisfaction Questionnaire |
3.30 | — |
| PRIMARY Number of Participants With VR Side Effects |
20 | — |
| SECONDARY Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) |
1.15 | — |
| SECONDARY Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale |
2.86 | — |
| SECONDARY Change in Tension as Measured With the Visual Analog Scale (VAS) |
7.70 | — |
| SECONDARY Change in Distress as Measured With the Visual Analog Scale (VAS) |
7.60 | — |
| SECONDARY Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale |
0.88 | — |
| SECONDARY Change in Pain Self-efficacy as Measured Using Items Adapted From the Self-efficacy for Pain Management Subscale of the Chronic Pain Self-Efficacy Scale |
72.60 | — |
Summary
Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients. VR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress.
The proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress.
The investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.
Eligibility Criteria
Inclusion Criteria
- age 18-85
- a diagnosis of stage IV colorectal cancer
- clinical pain documented in medical chart (>4 on a 0-10 scale) and confirmed on the day of their study appointment (>4 on a 0-10 scale)
- being able to read and speak English
- self-reported normal or corrected to normal vision
- self-reported normal hearing
Exclusion Criteria
- a serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records
- a medical condition that contraindicates safe participation in the study (e.g., recent myocardial infarction)
- visual, hearing, or cognitive impairment that will interfere with the patient's ability to engage in the intervention
Data sourced from ClinicalTrials.gov (NCT04069702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.