Colorectal Cancer
Conditions
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.
Interventions
BEHAVIORALVR Blue
VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Sponsors
University of Colorado, Denver
Palliative Care Research Cooperative Group
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, Assessed by Examining Number of Participants Accrued | 6 months | Feasibility was assessed by examining number of participants accrued. |
| Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol | 30 minutes | Feasibility will be assessed by examining protocol adherence (\>80% adherence to the protocol \[defined in this study as the degree to which participants are willing and able to complete the 30-minute VR exposure\]) |
| Feasibility, Assessed by Number of Participants With Completed Data | 90 minutes | Feasibility will be assessed by examining completed data (\>80% data collected at the study appointment, including pre-, midpoint, and post-VR assessments) |
| Acceptability Using the Client Satisfaction Questionnaire | 90 minutes | 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. |
| Number of Participants With VR Side Effects | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) | Pre-, post-VR session, approximately 90 minutes | 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. |
| 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 | 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 of change from pre-VR session to post-VR session for pain self-efficacy. |
| Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale | Pre-VR session assessment | 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. |
| 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. | 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. |
| 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. | 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. |
| Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale | 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. 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
VR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | VR Blue |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 56.7 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Pain Right Now | 2.8 units on a scale STANDARD_DEVIATION 1.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR Blue | Acceptability Using the Client Satisfaction Questionnaire | 3.30 score on a scale | Standard Deviation 0.41 |
Primary
Feasibility, Assessed by Examining Number of Participants Accrued
Feasibility was assessed by examining number of participants accrued.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR Blue | Feasibility, Assessed by Examining Number of Participants Accrued | 20 Participants |
Primary
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 \[defined in this study as the degree to which participants are willing and able to complete the 30-minute VR exposure\])
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR Blue | Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol | 20 Participants |
Primary
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)
Time frame: 90 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR Blue | Feasibility, Assessed by Number of Participants With Completed Data | 20 Participants |
Primary
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
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VR Blue | Number of Participants With VR Side Effects | 20 Participants |
Secondary
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.
Time frame: Pre- and post-VR session, Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR Blue | Change in Distress as Measured With the Visual Analog Scale (VAS) | 7.60 score on a scale | Standard Deviation 13.59 |
Secondary
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.
Time frame: Pre- and post-VR session, approximately 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR Blue | Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale | 0.88 score on a scale | Standard Deviation 0.89 |
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
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.
Time frame: Pre- and post-VR session, approximately 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR Blue | 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 score on a scale | Standard Deviation 16.49 |
Secondary
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.
Time frame: Pre-, post-VR session, approximately 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR Blue | Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) | 1.15 score on a scale | Standard Deviation 1.14 |
Secondary
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.
Time frame: Pre-, post-VR session. Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR Blue | Change in Tension as Measured With the Visual Analog Scale (VAS) | 7.70 score on a scale | Standard Deviation 12.7 |
Secondary
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.
Time frame: Pre-VR session assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR Blue | Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale | 2.86 score on a scale | Standard Deviation 2.07 |