Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04723108
Status:
WITHDRAWN
Last Update Posted:
2022-10-10
First Post:
2021-01-22
Brief Title:
Virtual Reality for Chemotherapy Patients
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Virtual Reality as a Symptom Control Intervention for Women With Gynecologic Cancer Receiving Chemotherapy A Pilot Proof of Concept Study
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment and researcher left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Gynecologic cancer encompasses various conditions such as uterine ovarian cervical peritoneal fallopian tube vaginal and vulvar cancers Of these uterine cancer is the top 4th cancer diagnosed and ovarian cancer the 5th deadliest in women
Many of these patients require some form of chemotherapy administration during their treatment course Chemotherapy is given at different stages of the treatment course with some patients receiving it prior to surgical intervention neo-adjuvant post-surgical intervention adjuvant and in the recurrent disease setting Chemotherapy infusions can cause distressing side effects to the patients in the form of physical and also emotionalpsychological effects which may disrupt compliance to treatment protocols Physical symptoms often begin during the administration of chemotherapy such as nausea vomiting fatigue pain and anorexia As a result patients frequently experience psychological distress including feelings of depression helplessness anxiety and cognitive decline These directly interfere with the patients ability to perform activities of daily living and daily quality of life The purpose of this study is to assess the effect of virtual reality VR sessions as a distraction intervention at time of chemotherapy infusion on symptom control
VR creates an alternative less stressful environment and is easy to use Users of VR wear a head-mounted display with a close proximity screen that creates a sense of being transported into a 3-dimensional world The technology can be individualized to be interactive and allows for an immersion experience by engaging several senses simultaneously Importantly VR has become increasingly portable immersive and inexpensive to adopt VR does not require a subjects experience or competency prior to use in the clinical setting VR has been used to assess and treat a wide variety of medical surgical psychiatric and neurocognitive conditions including pain addiction anxiety disorders schizophrenia eating disorders and stroke rehabilitation
There have also been functional MRI studies demonstrating the effect of VR on the brain during receipt of painful stimuli Multiple studies have demonstrated the benefit of VR as a distraction intervention for decreasing symptom distress particularly in regards to anxiety distress and fatigue and have demonstrated that it is feasible to integrate in the chemotherapy setting for patients receiving treatments for various cancers as well as when enduring medical procedures
In summary VR has been shown to be safe and effective in reducing emotional distress of patients undergoing chemotherapy These studies are generally limited in small sample size but all have shown to be safe and feasible To date the benefit of VR during chemotherapy infusion has not been evaluated in patients with gynecologic cancer
Many of these patients require some form of chemotherapy administration during their treatment course Chemotherapy is given at different stages of the treatment course with some patients receiving it prior to surgical intervention neo-adjuvant post-surgical intervention adjuvant and in the recurrent disease setting Chemotherapy infusions can cause distressing side effects to the patients in the form of physical and also emotionalpsychological effects which may disrupt compliance to treatment protocols Physical symptoms often begin during the administration of chemotherapy such as nausea vomiting fatigue pain and anorexia As a result patients frequently experience psychological distress including feelings of depression helplessness anxiety and cognitive decline These directly interfere with the patients ability to perform activities of daily living and daily quality of life The purpose of this study is to assess the effect of virtual reality VR sessions as a distraction intervention at time of chemotherapy infusion on symptom control
VR creates an alternative less stressful environment and is easy to use Users of VR wear a head-mounted display with a close proximity screen that creates a sense of being transported into a 3-dimensional world The technology can be individualized to be interactive and allows for an immersion experience by engaging several senses simultaneously Importantly VR has become increasingly portable immersive and inexpensive to adopt VR does not require a subjects experience or competency prior to use in the clinical setting VR has been used to assess and treat a wide variety of medical surgical psychiatric and neurocognitive conditions including pain addiction anxiety disorders schizophrenia eating disorders and stroke rehabilitation
There have also been functional MRI studies demonstrating the effect of VR on the brain during receipt of painful stimuli Multiple studies have demonstrated the benefit of VR as a distraction intervention for decreasing symptom distress particularly in regards to anxiety distress and fatigue and have demonstrated that it is feasible to integrate in the chemotherapy setting for patients receiving treatments for various cancers as well as when enduring medical procedures
In summary VR has been shown to be safe and effective in reducing emotional distress of patients undergoing chemotherapy These studies are generally limited in small sample size but all have shown to be safe and feasible To date the benefit of VR during chemotherapy infusion has not been evaluated in patients with gynecologic cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None