Virtual Reality for Chemotherapy Patients

NCT04723108 | Withdrawn

• 1 other identifier: AAAS5430
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this feasibility prospective study is to explore if the use of virtual reality as a distraction intervention for women with gynecologic cancer during chemotherapy administration reduces adverse symptoms. In this study, the treatment participants serve as their own control. The study will be performed over a 3 month period limit in order to assess implementation capability and symptom management of gynecologic cancer patients receiving chemotherapy treatment at Columbia University Irving Medical Center (CUIMC).

Conditions

Oncologic Complications

Keywords

chemotherapy; side effects; gynecologic cancers; meditative experience; virtual reality (VR)

Outcome Measures

Primary Outcomes (2)

• Symptom Survey A

  Symptom Survey A will be administered prior to first three chemotherapy infusions. Descriptive statistics will be utilized to characterize the survey question response proportions (i.e., distribution of responses to questions on the survey) (frequency, percent). Estimated differences in survey responses between 1) patient's perception pre-intervention vs. 2) patient's perception post-intervention, will be evaluated by the two-sample t-test, Wilcoxon rank-sum test, chi-square test, and Fisher's exact test, as appropriate. All analyses will be performed in SAS version 9.3

  upto 3 months

• Symptom Survey B

  Symptom Survey B will be administered after the third chemotherapy infusion. Descriptive statistics will be utilized to characterize the survey question response proportions (i.e., distribution of responses to questions on the survey) (frequency, percent). Estimated differences in survey responses between 1) patient's perception pre-intervention vs. 2) patient's perception post-intervention, will be evaluated by the two-sample t-test, Wilcoxon rank-sum test, chi-square test, and Fisher's exact test, as appropriate. All analyses will be performed in SAS version 9.3

  3-4 months

Study Arms (1)

Virtual reality arm

EXPERIMENTAL

Participants will be asked to use virtual reality during their infusion for a duration of at least 10 minutes.

Other: Destek V4 Virtual Reality Headset

Interventions

Destek V4 Virtual Reality Headset OTHER

The DESTEK V4 is a smartphone VR headset made by DESTEK, a manufacturer based in the US. This mobile virtual reality headset is compatible with most iOS and Android smartphones, as long as their screen size is between 4.5 and 6.

Virtual reality arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All gynecologic oncology patients undergoing intravenous (IV) chemotherapy as standard of care treatment for their disease.
• Age greater than or equal to 18 years
• Patients willing to participate on surveys prior to and post chemotherapy infusion treatments
• Patient must own or have access to an iphone or android device with virtual reality application capability

You may not qualify if:

• Patients with hearing impairment
• Patients with known balance disorders such as vertigo/cybersickness
• Patients with known history of epileptic seizures
• Patients who are unable to wear the virtual reality headset
• Patients who are not receiving pre-chemotherapy labs as part of their standard treatment protocol
• Patients who receive additional intravenous medications, such as antihypertensives, steroids, analgesics, anxiolytics during chemotherapy session that is not part of the standard chemotherapy regimen.

Sponsors & Collaborators

• Columbia University: lead

Study Officials

• June Y. Hou, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 25, 2021
• Study Start: June 1, 2022
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share