Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069702
Recruitment Status : Suspended (COVID-19 restrictions on in person activities for non-essential studies)
First Posted : August 28, 2019
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
Palliative Care Research Cooperative Group
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Duke University

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. 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: VR Blue Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Testing a Virtual Reality Protocol for Improving Pain and Pain-Related Distress in Patients With Advanced Stage Colorectal Cancer
Actual Study Start Date : March 12, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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.




Primary Outcome Measures :
  1. Feasibility, assessed by examining study accrual (N=20 over 6 months) [ Time Frame: 6 months ]
  2. Feasibility, assessed by examining protocol adherence [ Time Frame: 30 minutes ]
    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])

  3. Feasibility, assessed by completed data [ Time Frame: 90 minutes ]
    Feasibility will be assessed by examining completed data (>80% data collected at the study appointment, including pre-, midpoint, and post-VR assessments)

  4. Acceptability using the Client Satisfaction Questionnaire [ Time Frame: 90 minutes ]
    This questionnaire contains 10 items rated from 1=low acceptability to 4=high acceptability; scores are created by summing patient responses and result in total possible scores ranging from 10-40. The participant will complete this acceptability questionnaire as part of their post-VR session assessment.

  5. Safety, assessed based on participants' report of VR side effects [ Time Frame: 30 minutes ]
    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


Secondary Outcome Measures :
  1. Change in pain severity as assessed with the Brief Pain Inventory (BPI) [ Time Frame: Pre-, midpoint and post-VR session, approximately 90 minutes ]
    Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their pain from 0=no pain to 10=worst pain imaginable in response to items such as "average pain," "worst pain" and "least pain" over the last 7 days and "pain right now". An average of the responses to these items is used to create a single pain severity score.

  2. Change in pain interference as assessed with the Brief Pain Inventory (BPI) [ Time Frame: Pre-, midpoint and post-VR session, approximately 90 minutes ]
    Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their pain from 0=no pain to 10=worst pain imaginable in response to items such as "average pain," "worst pain" and "least pain" over the last 7 days and "pain right now". An average of the responses to these items is used to create a single pain severity score.

  3. Change in tension as measured with the Profile of Mood States Short Form (POMS-SF) tension/anxiety subscale [ Time Frame: Pre-, midpoint and post-VR session, approximately 90 minutes ]
    POMS-SF items are rated on a 0=not at all to 4=extremely scale.

  4. Change in distress as measured with the Profile of Mood States Short Form (POMS-SF) depression subscale [ Time Frame: Pre-, midpoint and post-VR session, approximately 90 minutes ]
    POMS-SF items are rated on a 0=not at all to 4=extremely scale.

  5. Change in pain catastrophizing as measured with the Coping Strategies Questionnaire's Pain Catastrophizing subscale [ Time Frame: Pre- and post-VR session, approximately 90 minutes ]
    Items will be rated on a scale ranging from 0=never do to 6=always do when in pain.

  6. 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 [ Time Frame: Pre- and post-VR session, approximately 90 minutes ]
    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 for pain self-efficacy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069702


Locations
Layout table for location information
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
University of Colorado, Denver
Palliative Care Research Cooperative Group
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Sarah A Kelleher, PhD Duke University
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04069702    
Other Study ID Numbers: Pro00103248
U2CNR014637 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases