Hematopoietic and Lymphoid System NeoplasmNCT05793957
Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms
A study testing Questionnaire Administration, Telephone-Based Intervention and Virtual Technology Intervention in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Breast Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Breast Neoplasm, Malignant Head and Neck Neoplasm
- What is being tested?
- Questionnaire Administration, Telephone-Based Intervention and Virtual Technology Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 28 Sep 2023
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking: Ability to interact with virtual reality content may be impacted by inability to understand English; moreover, paper questionnaires will only be provided in English.
- Older than 18 years of age, and younger than 89 years of age. All sexes/gender identities and members of all races and ethnic groups will be included.
- Planned to receive chemotherapy infusion for head and neck, breast, thoracic, and hematologic cancers at the Oregon Health \& Science University (OHSU) South Waterfront Center for Health \& Healing building 2 (there are no restrictions related to prior chemotherapy infusions or other cancer treatments).
- Chemotherapy treatment lasting at least 10 minutes.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Social or psychiatric conditions that may interfere with compliance.
- Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset. This would limit the ability to utilize the VR headset.
- History of seizure or epilepsy.
- History of vertigo or persistent dizziness.
- Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators.
- Children.
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- Pregnant women.
- Decisionally impaired adults.
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Anxiety in the Context of Chemotherapy Infusion: Is There an Association Between the Use of Virtual Reality Goggles and Changes in Anxiety-Related Symptoms?
This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Virtual reality headsets provide the ability for users to explore a simulated, three-dimensional environment with which users can interact. In virtual reality users can play interactive games, enjoy relaxing experiences, and watch immersive videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms during chemotherapy infusion, compared to participants utilizing a smartphone as a control.
SECONDARY OBJECTIVES:
- To evaluate whether there is a short-term effect of VR use in anxiety levels.
II. To assess participant satisfaction with their chemotherapy infusion experience in the control and treatment groups.
EXPLORATORY OBJECTIVE:
- To assess participants' reported adverse effects associated with VR headset use.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients use VR during chemotherapy infusion on study.
GROUP 2: Patients use smartphone during chemotherapy infusion on study.
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Malignant Breast Neoplasm, Malignant Head and Neck Neoplasm, Malignant Solid Neoplasm, Malignant Thoracic Neoplasm
- Being tested
- Questionnaire Administration, Telephone-Based Intervention, Virtual Technology Intervention
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Use smartphone
Virtual Technology InterventionOther
Also called Virtual Reality Intervention, Virtual Technology
Use VR headset
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (VR) | Experimental | Patients use VR during chemotherapy infusion on study. Receives: Other: Questionnaire Administration; Other: Virtual Technology Intervention |
| Group 2 (Smartphone) | Active comparator | Patients use smartphone during chemotherapy infusion on study. Receives: Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in anxiety levels
Will be assessed in the treatment and control groups determined by the difference in the scores provided by the State Anxiety Inventory before and right after VR use. Range of scores is 20-80, the higher score indicating greater anxiety. Will be compared using two-sample t-test to compare the anxiety levels change before and after VR between intervention group and control group (VR vs control). The effect of VR on anxiety levels will be described using a linear regression model addressing the unanticipated imbalance between treatment groups after randomization adjusting for the confounder.
Measured: Before the start of chemotherapy infusion and 30-minutes of virtual reality (VR)/smartphone use is completed
Secondary outcomes (2)
Short-term difference in anxiety levels
Will be assessed by the difference in anxiety levels right before VR use and immediately after chemotherapy infusion is completed as provided by the State Anxiety Inventory using a two sample t-test. Range of scores is 20-80, with a higher score indicating greater anxiety.
Measured: Before VR goggle use and immediately after chemotherapy infusion is complete
Participants' satisfaction with the VR device
Will be assessed by an investigator-designed satisfaction questionnaire after chemotherapy completion to assess participants' satisfaction with the VR device using descriptive statistics to summarize this data.
Measured: Immediately after chemotherapy infusion is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start20 Apr 2023
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Ryan Li, MD, OHSU Knight Cancer Institute
- Investigators
- Ryan J Li, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793957
- Sponsor's protocol ID
- STUDY00025461
- Other IDs
- NCI-2023-01954, STUDY00025461
- Status last verified
- Dec 2023
- First submitted
- 17 Mar 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety in the Context of Chemotherapy Infusion: Is There an Association Between the Use of Virtual Reality Goggles and Changes in Anxiety-Related Symptoms?
- ClinicalTrials.gov ID
- NCT05793957
- Acronym / sponsor ID
- STUDY00025461
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Malignant Breast Neoplasm, Malignant Head and Neck Neoplasm, Malignant Solid Neoplasm, Malignant Thoracic Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 31 Mar 2023 (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.
This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Virtual reality headsets provide the ability for users to explore a simulated, three-dimensional environment with which users can interact. In virtual reality users can play interactive games, enjoy relaxing experiences, and watch immersive videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms during chemotherapy infusion, compared to participants utilizing a smartphone as a control.
SECONDARY OBJECTIVES:
- To evaluate whether there is a short-term effect of VR use in anxiety levels.
II. To assess participant satisfaction with their chemotherapy infusion experience in the control and treatment groups.
EXPLORATORY OBJECTIVE:
- To assess participants' reported adverse effects associated with VR headset use.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients use VR during chemotherapy infusion on study.
GROUP 2: Patients use smartphone during chemotherapy infusion on study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (VR) | Experimental | Other: Questionnaire Administration, Other: Virtual Technology InterventionPatients use VR during chemotherapy infusion on study. |
| Group 2 (Smartphone) | Active comparator | Other: Questionnaire Administration, Behavioral: Telephone-Based InterventionPatients use smartphone during chemotherapy infusion on study. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English speaking: Ability to interact with virtual reality content may be impacted by inability to understand English; moreover, paper questionnaires will only be provided in English.
- Older than 18 years of age, and younger than 89 years of age. All sexes/gender identities and members of all races and ethnic groups will be included.
- Planned to receive chemotherapy infusion for head and neck, breast, thoracic, and hematologic cancers at the Oregon Health \& Science University (OHSU) South Waterfront Center for Health \& Healing building 2 (there are no restrictions related to prior chemotherapy infusions or other cancer treatments).
- Chemotherapy treatment lasting at least 10 minutes.
- Ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (9 listed)
- Social or psychiatric conditions that may interfere with compliance.
- Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset. This would limit the ability to utilize the VR headset.
- History of seizure or epilepsy.
- History of vertigo or persistent dizziness.
- Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators.
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 |
|---|---|---|
| Questionnaire AdministrationAncillary studies | Other | Group 1 (VR), Group 2 (Smartphone) |
| Telephone-Based InterventionUse smartphone | Behavioural | Group 2 (Smartphone) |
| Virtual Technology InterventionAlso: Virtual Reality Intervention, Virtual TechnologyUse VR headset | Other | Group 1 (VR) |
Primary outcome
Difference in anxiety levels
Time frame: Before the start of chemotherapy infusion and 30-minutes of virtual reality (VR)/smartphone use is completed
Will be assessed in the treatment and control groups determined by the difference in the scores provided by the State Anxiety Inventory before and right after VR use. Range of scores is 20-80, the higher score indicating greater anxiety. Will be compared using two-sample t-test to compare the anxiety levels change before and after VR between intervention group and control group (VR vs control). The effect of VR on anxiety levels will be described using a linear regression model addressing the unanticipated imbalance between treatment groups after randomization adjusting for the confounder.
2 secondary outcomes
Short-term difference in anxiety levels
Time frame: Before VR goggle use and immediately after chemotherapy infusion is complete
Participants' satisfaction with the VR device
Time frame: Immediately after chemotherapy infusion is complete
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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.
Ryan J Li principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration, Telephone-Based Intervention and Virtual Technology Intervention in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Breast Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in anxiety levels (time frame: Before the start of chemotherapy infusion and 30-minutes of virtual reality (VR)/smartphone use is completed). 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 19 Dec 2023.