Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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.
    

Intervention name(s): VR Blue
Intervention type(s): Behavioral
Intervention description(s): VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment