Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer (VR Blue)

Pilot Testing a Virtual Reality Protocol for Improving Pain and Pain-Related Distress in Patients With Advanced Stage Colorectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: VR Blue

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR Blue; VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.	Behavioral: VR Blue; VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility, Assessed by Examining Number of Participants Accrued	Feasibility was assessed by examining number of participants accrued.	6 months
Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol	Feasibility will be assessed by examining protocol adherence (>80% adherence to the protocol [defined in this study as the degree to which participants are willing and able to complete the 30-minute VR exposure])	30 minutes
Feasibility, Assessed by Number of Participants With Completed Data	Feasibility will be assessed by examining completed data (>80% data collected at the study appointment, including pre-, midpoint, and post-VR assessments)	90 minutes
Acceptability Using the Client Satisfaction Questionnaire	This questionnaire contains 10 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to average Client Satisfaction Questionnaire answers resulting in a score range from 1-4. The participant will complete this acceptability questionnaire as part of their post-VR session assessment.	90 minutes
Number of Participants With VR Side Effects	Safety of the VR protocol will be assessed based on participants' report of VR side effects, such as motion sickness, dizziness, headache, nausea, or other negative physical reactions	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)	Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "pain right now" from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.	Pre-, post-VR session, approximately 90 minutes
Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale	Pain interference will be assessed with the Brief Pain Inventory (BPI) - Pain Interference Scale. Patients will rate how much pain interfered with a variety of activities and mood states over the last 7 days from 0=does not interfere to 10=completely interferes. An average of the responses to these items is used to create a single pain severity score.	Pre-VR session assessment
Change in Tension as Measured With the Visual Analog Scale (VAS)	Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no tension at all, 100=maximum tolerable tension. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.	Pre-, post-VR session. Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
Change in Distress as Measured With the Visual Analog Scale (VAS)	Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no stress at all, 100=maximum tolerable stress. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.	Pre- and post-VR session, Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale	Items will be rated on a scale ranging from 0=never do to 6=always do when in pain. An average of the responses to these items is used to create a single score of change from pre-VR session to post-VR session.	Pre- and post-VR session, approximately 90 minutes
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	Self-efficacy will be measured using items adapted from the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale. Items are rated on a 10-point scale ranging from 10=very uncertain to 100=very certain. Scores are averaged to give an overall value of change from pre-VR session to post-VR session for pain self-efficacy.	Pre- and post-VR session, approximately 90 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of Colorado, Denver; National Institute of Nursing Research (NINR); National Institutes of Health (NIH); Palliative Care Research Cooperative Group
• Investigators: Principal Investigator: Sarah A Kelleher, PhD, Duke University

Publications and helpful links

Helpful Links

• Pre-print: Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A Randomized Clinical Trial

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): July 19, 2021
• Study Completion (Actual): July 19, 2021

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Pro00103248; U2CNR014637 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As part of the NIH data sharing directive, de-identified data from this study will be transferred to the PCRC De-Identified Data Repository located at the University of Colorado. The PCRC fully supports the Final NIH Statement on Sharing Research Data, and will assist all investigators and study personnel to ensure their compliance. Consistent with OMB Circular A-110 and subsequent NIH Grants Policy Statements, the PCRC will provide access to all de-identified data collected as part of PCRC-supported investigations, insofar as access is consistent with IRB/CHR rules, local, state, and Federal laws and regulations, and the HIPAA Privacy Rule.
• IPD Sharing Time Frame: Data will become available after completion of the study and when summary data are published and otherwise made available. From this timepoint, data will be available for 5 years.
• IPD Sharing Access Criteria: The Principal Investigator will work with requesters and IRBs on a case by case basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No