Rectal Cancer Clinical Trial
Official title:
Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | March 2026 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period - Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible - Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score - Ability to read and write in English Exclusion Criteria: - Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments - Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible. - Have brain metastases - Have a prognosis of <3 months from the time of enrollment per treating oncologist |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient-Reported Outcomes Measurement Information System Pain Interference 4a | Pain interference over time as measured by Patient-Reported Outcomes Measurement Information System-Pain Interference 4a delivered on a weekly basis (T-Scored, Continuous, 1-5, higher the worse). | Over 60 days | |
Other | Patient Global Impression of Change | Patient Global Impression of Change over time as measured by Patient Global Impression of Change Scale delivered on a weekly basis (PGIC, 1-7, higher the worse). | Over 60 days | |
Other | Patient-Reported Outcomes Measurement Information System Social Isolation | Social Isolation over time as measured weekly by Patient-Reported Outcomes Measurement Information System Social Isolation short form 4a. delivered on a weekly basis (1-5, higher the worse) | Over 60 days | |
Other | Pain Catastrophizing scale 4 item short form. | Pain catastrophizing over time as measured by Pain Catastrophizing scale (PCS) 4 item short form delivered on a weekly basis (0-4, from not at all to all the time, higher the worse). | Over 60 days | |
Other | Steps taken per day | Steps taken per day over time as measured by Fitbit smartwatch. | Continuous for 60 days | |
Other | Minutes of sleep over time | Minutes of sleep over time as measured by Fitbit smartwatch. | Continuous for 60 days | |
Other | Pain coping skills survey | Assessment of pain coping skills over time as measured by a custom pain coping skills survey. | Day 60 | |
Other | Pain Self-Efficacy Questionnaire (PSEQ) 2-item short form | Pain self-efficacy over time as measured by The Pain Self-Efficacy Questionnaire (PSEQ) 2-item short form delivered on a weekly basis (0-6, higher the better). | Over 60 days | |
Other | Dosage of VR (minutes per week) | minutes of use per week will be extracted from the VR device via wifi network | Continuous for 60 days | |
Primary | Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain over 30 days from the baseline | Gastrointestinal Belly Pain over time as measured by Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain 5a delivered on a weekly basis (T-Scored, Continuous, 1-5, higher the worse). | Over 30 days from the baseline | |
Secondary | Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain | Gastrointestinal Belly Pain over time as measured by Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain 5a delivered on a weekly basis (T-Scored, Continuous, 1-5, higher the worse). | Over 60 days | |
Secondary | Daily pain intensity | Daily pain intensity for one week at baseline, week of Day 30, and week of Day 60 as measured by Daily Pain Intensity Scale (0-10, where 0 means no pain and 10 means the worst pain imaginable). | At baseline, week of Day 30, and week of Day 60 | |
Secondary | Patient-Reported Outcomes Measurement Information System Global physical and mental health | Global physical and mental health over time as measured by Patient-Reported Outcomes Measurement Information System Global Physical and Mental 2a. delivered on a weekly basis (1-5, higher the better) | Over 60 days | |
Secondary | Opioid prescriptions of Morphine Milligram Equivalents (MME) | Comparing the change from study baseline to Day 60 in weekly MME of prescribed medication. | In a 60-day period |
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