Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer

NCT04069702 | Completed Results DMC

• 2 other identifiers: Pro00103248U2CNR014637
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)

  Pre-, post-VR session, approximately 90 minutes

• Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale

  Pre-VR session assessment

• Change in Tension as Measured With the Visual Analog Scale (VAS)

  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)

  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

  Pre- and post-VR session, approximately 90 minutes

Study Arms (1)

VR Blue

EXPERIMENTAL

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

Interventions

VR Blue BEHAVIORAL

VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.

VR Blue

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• University of Colorado, Denver: collaborator
• Palliative Care Research Cooperative Group: collaborator
• National Institute of Nursing Research (NINR): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27701, United States

Location

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Sarah Kelleher, PhD
• Organization: Duke University

sarah.kelleher@duke.edu

9194163405

Study Officials

• Sarah A Kelleher, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: March 12, 2020
• Primary Completion: July 19, 2021
• Study Completion: July 19, 2021
• Last Updated: July 10, 2023
• Results First Posted: August 22, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: The Principal Investigator will work with requesters and IRBs on a case by case basis.

Locations

US (1)