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NCT04907643 · ClinicalTrials.gov registry record · NA

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

A NA study of Colon Cancer and Liver Cancer, sponsored by Cedars-Sinai Medical Center.

Recruiting
Registry status
NA
Development phase
360
Enrollment target
1
Study location

NCT04907643 is a NA study of Colon Cancer and Liver Cancer that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 360 participants, below the 4,453-participant average among 97 other Colon Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04907643, a NA study of Colon Cancer and Liver Cancer, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.

RECRUITING
Registry status
NA
Development phase
360 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • DEVICE PICO G2 4k

Study Locations (1)

California

  • Cedars-Sinai Medical Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2021-10-05
Est. Completion 2027-03-16
Phase NA

Sponsor

Cedars-Sinai Medical Center

339 total trials

What the Registry Record Tells You About NCT04907643

The ClinicalTrials.gov registry entry for NCT04907643 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,453-participant average among 97 other Colon Cancer trials with a reported enrollment target (92% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Colon Cancer appearing as the primary indexed condition, and to 1 intervention - of which PICO G2 4k is the first listed.

NCT04907643 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04907643 about?

NCT04907643 is a clinical study titled "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 treatmen...

What is the current status of trial NCT04907643?

This trial is currently recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2021-10-05. Estimated completion is 2027-03-16.

What conditions does trial NCT04907643 study?

This clinical trial studies the following conditions: Colon Cancer, Liver Cancer, Pancreas Cancer, Biliary Tract Cancer, Cancer Pain.

What interventions are being tested in trial NCT04907643?

The interventions under investigation include: PICO G2 4k (DEVICE).

Who is sponsoring clinical trial NCT04907643?

This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04907643 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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