Oncologic ComplicationsNCT04723108
Virtual Reality for Chemotherapy Patients
A study testing Destek V4 Virtual Reality Headset in people with Oncologic Complications, run by Columbia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oncologic Complications
- What is being tested?
- Destek V4 Virtual Reality Headset
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Virtual Reality as a Symptom Control Intervention for Women With Gynecologic Cancer Receiving Chemotherapy: A Pilot Proof of Concept Study
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).
Read the 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 emotional/psychological 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 patient's 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 subject's 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.
- Conditions
- Oncologic Complications
- Being tested
- Destek V4 Virtual Reality Headset
- Keywords
- chemotherapy, side effects, gynecologic cancers, meditative experience, virtual reality (VR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Destek V4 Virtual Reality HeadsetOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality arm | Experimental | Participants will be asked to use virtual reality during their infusion for a duration of at least 10 minutes. Receives: Other: Destek V4 Virtual Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study startJun 2022 (estimated)
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Why it stopped: Poor enrollment and researcher left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic ComplicationsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- June Y. Hou, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723108
- Sponsor's protocol ID
- AAAS5430
- Status last verified
- Oct 2022
- First submitted
- 22 Jan 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Symptom Control Intervention for Women With Gynecologic Cancer Receiving Chemotherapy: A Pilot Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04723108
- Acronym / sponsor ID
- AAAS5430
- Conditions
- Oncologic Complications
- Keywords
- chemotherapy, side effects, gynecologic cancers, meditative experience, virtual reality (VR)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor enrollment and researcher left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 emotional/psychological 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 patient's 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 subject's 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality arm | Experimental | Other: Destek V4 Virtual Reality HeadsetParticipants will be asked to use virtual reality during their infusion for a duration of at least 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Destek V4 Virtual Reality HeadsetThe 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. | Other | Virtual reality arm |
Primary outcome
Symptom Survey A
Time frame: upto 3 months
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
Symptom Survey B
Time frame: 3-4 months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June Y. Hou, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Destek V4 Virtual Reality Headset in people with Oncologic Complications, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Survey A (time frame: upto 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.