Randomized Controlled Trial of Virtual Reality Assisted Guided Imagery (VRAGI) for Pain in Advanced Cancer Patients.

Introduction Patients with advanced cancer often experience high levels of debilitating pain and pain-related psychological distress. Although there is increasing evidence that non-pharmacological strategies are needed to treat their pain, pharmacologic modalities remain the preferred strategy. Guided imagery is a form of focused relaxation that helps create harmony between the mind and body and has been shown to significantly improve cancer pain. This study presents Virtual Reality Assisted Guided Imagery (VRAGI) as an alternative pain treatment modality. The investigators of this study will conduct a randomized control trial to test its efficacy, feasibility, and safety in the home setting, for patients with advanced cancer. Methods and Analysis The study will recruit 80 participants from Prisma Health, a tertiary level health care center based in Greenville, South Carolina, USA using a stringent set of inclusion and exclusion criteria. The prospective 6-week, 2x2 randomized controlled trial will randomize participants to four groups: (1) VRAGI, (2) Laptop Assisted Guided Imagery (AGI), (3) VR (no guided imagery or other audio), and (4) laptop (no guided imagery or other audio). Participants allocated to VR groups will be trained to use a head-mounted display (HMD) that immerses them in 3D audio-video content. The non-VR group will use a laptop displaying 2D video content. Content includes relaxing natural scenes across three calendar seasons (spring, summer, fall). Investigators will collect measures pre, during, and post intervention including patient reported outcomes (PROs) of pain, anxiety, depression, fatigue. Additionally, investigators will assess the feasibility, acceptability and safety of VRAGI use in a home setting. Trial Registration Number #Pro00114598 Strengths and Limitations * This study uses a novel design that combines the use of immersive Virtual Reality (VR) technology with guided imagery processes to treat chronic pain in advanced cancer patients. * Investigators propose a reproducible intervention that can be self-administered in a home setting, thus eliminating the need for trained personnel, transportation modalities, or healthcare facilities. * VR content will be preloaded onto HMDs, thus eliminating the need for access to the internet and decreasing the variability of the intervention. * Investigators will collect patient reported outcomes (PROs) on pain, anxiety, depression, fatigue, and opioid use, but not continuous user feedback or biofeedback. * This study focuses on patients \< 65 years of age with advanced cancer. This allows the study to focus on a large group of patients but may limit the overall generalizability of the findings.

Sex

All

Minimum age

18 Years

Maximum age

65 Years

Inclusion Criteria:

1. \> 18 years of age
2. Advanced cancer, defined as cancer that is incurable including locally advanced and metastatic cancers, with no plan for resection during the study period.
3. Baseline pain score Edmonton Symptom Assessment Scale (ESAS) ≥ 4 (mean score during the screening week).
4. Able to provide consent and willing to comply with all study procedures, as well as comprehend spoken and written English.
5. Have access to a compatible Android, iOS smartphone, personal laptop, or desktop computer (excluding tablets) to complete surveys and respond to emails

Exclusion Criteria:

1. Have a condition that interferes with VR usage including history of seizure, facial injury precluding safe placement of an HMD, or other visual or hearing impairment that impacts ability to participate.
2. Participated in a previous VR clinical study.
3. Underwent a surgical procedure within 8 weeks.
4. Have a neurocognitive disorder according to past medical history.
5. Have brain metastases.
6. Have a prognosis of \<3 months from the time of enrollment per treating oncologist.
7. Experience current substance abuse.
8. Experienced complex childhood trauma.
9. Diagnosed with serious mental illness.
10. \>65 years of age

• BACKGROUNDBirckhead B, Eberlein S, Alvarez G, Gale R, Dupuy T, Makaroff K, Fuller G, Liu X, Yu KS, Black JT, Ishimori M, Venuturupalli S, Tu J, Norris T, Tighiouart M, Ross L, McKelvey K, Vrahas M, Danovitch I, Spiegel B. Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. BMJ Open. 2021 Jun 15;11(6):e050545. doi: 10.1136/bmjopen-2021-050545. PMID 34130965
• BACKGROUNDZeng Y, Zhang JE, Cheng ASK, Cheng H, Wefel JS. Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419871108. doi: 10.1177/1534735419871108. PMID 31441352
• BACKGROUNDBanos RM, Espinoza M, Garcia-Palacios A, Cervera JM, Esquerdo G, Barrajon E, Botella C. A positive psychological intervention using virtual reality for patients with advanced cancer in a hospital setting: a pilot study to assess feasibility. Support Care Cancer. 2013 Jan;21(1):263-70. doi: 10.1007/s00520-012-1520-x. Epub 2012 Jun 13. PMID 22688373
• DERIVEDHartshorn G, Browning M, Chalil Madathil K, Mau F, Ranganathan S, Todd A, Bertrand J, Maynard A, McAnirlin O, Sindelar K, Hernandez R, Henry Gomez T. Efficacy of virtual reality assisted guided imagery (VRAGI) in a home setting for pain management in patients with advanced cancer: protocol for a randomised controlled trial. BMJ Open. 2022 Dec 5;12(12):e064363. doi: 10.1136/bmjopen-2022-064363. PMID 36576188