Clinical trial NCT04069702: Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer
Official title: Pilot Testing a Virtual Reality Protocol for Improving Pain and Pain-Related Distress in Patients With Advanced Stage Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Palliative Care Research Cooperative Group
name: National Institute of Nursing Research (NINR)
name: National Institutes of Health (NIH)
First posted: 2019-08-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. Unfortunately, analgesics are not uniformly effective and often are associated with poorly tolerated side effects (e.g., constipation, nausea, sedation). 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. VR may be particularly likely to positively impact cognitive pathways by changing pain-related cognitions (e.g., decreasing pain catastrophizing, increasing self-efficacy for pain control). VR-based interventions have the potential to alter these negative ways of thinking, and advanced cancer patients with persistent pain and pain-related distress may be particularly likely to benefit.

The proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. That study found that exposure to a 30-minute virtual underwater/sea environment (VR Blue) produced significant increases in pain tolerance for thermal pain stimuli compared to control conditions. 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.

The long-term goal of this research is to improve quality of life in advanced colorectal cancer patients by decreasing pain, tension and distress. This project will provide preliminary data that will be used to inform and optimize development of a multi-session VR protocol to be tested in patients with advanced stage colorectal cancer that could be generalizable to other palliative care populations with pain.

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

Primary outcomes:
measure: Feasibility, Assessed by Examining Number of Participants Accrued
timeFrame: 6 months
measure: Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol
timeFrame: 30 minutes
measure: Feasibility, Assessed by Number of Participants With Completed Data
timeFrame: 90 minutes
measure: Acceptability Using the Client Satisfaction Questionnaire
timeFrame: 90 minutes
measure: Number of Participants With VR Side Effects
timeFrame: 30 minutes
Secondary outcomes:
measure: Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)
timeFrame: Pre-, post-VR session, approximately 90 minutes
measure: Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale
timeFrame: Pre-VR session assessment
measure: Change in Tension as Measured With the Visual Analog Scale (VAS)
timeFrame: Pre-, post-VR session. Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
measure: Change in Distress as Measured With the Visual Analog Scale (VAS)
timeFrame: Pre- and post-VR session, Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
measure: Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale
timeFrame: Pre- and post-VR session, approximately 90 minutes
measure: 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
timeFrame: Pre- and post-VR session, approximately 90 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Sarah A Kelleher, PhD
role: PRINCIPAL_INVESTIGATOR
References: