Breast CancerOU-SCC VRNCT05263648
Virtual Reality Software to Reduce Stress in Cancer Patients
A study testing Virtual Reality Session in people with Breast Cancer and Head and Neck Cancer, run by University of Oklahoma.
Trial summary
The purpose of this study is to test the ability of virtual reality-based social support to increase patient adherence to radiation therapy by reducing patient distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Head and Neck Cancer
- What is being tested?
- Virtual Reality Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Must be able to read and speak English
- Diagnosis of breast or head and neck cancer
- Treatment plan includes radiotherapy within the next 2 months
- Signed study-specific informed consent prior to study entry
Who cannot join
- Previous radiation therapy treatment
- Neurologic deficits
- Visual disorder
- Neuro-psychiatric disorder
- Use of neuro-psychiatric drugs
About this study
Official title: Feasibility Study of Virtual Reality Software to Reduce Stress in Cancer Patients Receiving Radiation Therapy
The purpose of this study is to test the ability of virtual reality-based social support to increase patient adherence to radiation therapy by reducing patient distress.
Read the detailed description
This study will involve patients who have been diagnosed with breast or head and neck cancer and are suitable to receive radiation therapy. It is a single arm pilot trial designed to provide information on the safety, feasibility, and impacts of incorporating virtual reality (VR) software into the treatment plan of patients receiving radiation therapy with the goal of increasing patient adherence to radiation therapy.
Patients will be provided with VR-based education sessions prior to and during the course of radiation therapy. Patients' emotional and social distress levels will be assessed with questionnaires to measure the impacts of the VR software. Patients will be in the study for up to 3 months during regular cancer care, but the total time for the study procedures is anticipated to be 2-4 hours in total. Results from this study will be for research only and will not impact treatment decisions.
- Conditions
- Breast Cancer, Head and Neck Cancer
- Being tested
- Virtual Reality Session
- Keywords
- Virtual Reality, Radiation Therapy, Education, Distress, Stress
- 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.
Virtual Reality SessionOther
VR-based education sessions will be used to influence patients' perceived emotional and social distress while undergoing radiation therapy (RT).
Emotional and social distress levels will be evaluated using questionnaires at baseline (prior to the first VR experience), at completion of RT, and at 30-60 days post RT.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Sessions | Other | Patients will undergo at least two VR sessions. One prior to and one during the course of radiation treatment. Receives: Other: Virtual Reality Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who complete 2 VR sessions
Percentage of patients who complete 2 VR sessions will be calculated.
Measured: Up to 3 Months
Proportion of patients reporting ease of use for VR sessions
Patients will be given a survey on their VR sessions to measure the ease of use and ability to provide useful information.
Measured: Up to 3 Months
Proportion of overall adherence to radiation therapy
Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.
Measured: Up to 3 Months
Secondary outcomes (3)
Change in state trait anxiety scale
Change in state trait anxiety scale from baseline to follow-up will be calculated
Measured: Up to 3 Months
Change in brief symptom inventory
Change in brief symptom inventory scale from baseline to follow-up will be calculated
Measured: Up to 3 Months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI)
Change in PROMIS Item Bank v2.0 - Social Isolation - Short Form 8a (SI) from baseline to follow-up will be calculated
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: due to an issue with the software developer that cannot be resolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Henson, MD, Principal investigator, Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263648
- Sponsor's protocol ID
- OU-SCC-Virtual Reality
- Acronym
- OU-SCC VR
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2022
- Last updated
- 14 Feb 2024
- 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 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Virtual Reality Software to Reduce Stress in Cancer Patients Receiving Radiation Therapy
- ClinicalTrials.gov ID
- NCT05263648
- Acronym / sponsor ID
- OU-SCC VR / OU-SCC-Virtual Reality
- Conditions
- Breast Cancer, Head and Neck Cancer
- Keywords
- Virtual Reality, Radiation Therapy, Education, Distress, Stress
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to an issue with the software developer that cannot be resolved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 Mar 2022 (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 study is to test the ability of virtual reality-based social support to increase patient adherence to radiation therapy by reducing patient distress.
Detailed description
This study will involve patients who have been diagnosed with breast or head and neck cancer and are suitable to receive radiation therapy. It is a single arm pilot trial designed to provide information on the safety, feasibility, and impacts of incorporating virtual reality (VR) software into the treatment plan of patients receiving radiation therapy with the goal of increasing patient adherence to radiation therapy.
Patients will be provided with VR-based education sessions prior to and during the course of radiation therapy. Patients' emotional and social distress levels will be assessed with questionnaires to measure the impacts of the VR software. Patients will be in the study for up to 3 months during regular cancer care, but the total time for the study procedures is anticipated to be 2-4 hours in total. Results from this study will be for research only and will not impact treatment decisions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Sessions | Other | Other: Virtual Reality SessionPatients will undergo at least two VR sessions. One prior to and one during the course of radiation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Must be able to read and speak English
- Diagnosis of breast or head and neck cancer
- Treatment plan includes radiotherapy within the next 2 months
- Signed study-specific informed consent prior to study entry
Key exclusion criteria (5 listed)
- Previous radiation therapy treatment
- Neurologic deficits
- Visual disorder
- Neuro-psychiatric disorder
- Use of neuro-psychiatric drugs
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 |
|---|---|---|
| Virtual Reality SessionVR-based education sessions will be used to influence patients' perceived emotional and social distress while undergoing radiation therapy (RT). Emotional and social distress levels will be evaluated using questionnaires at baseline (prior to the first VR experience), at completion of RT, and at 30-60 days post RT. | Other | Virtual Reality Sessions |
Primary outcome
Proportion of patients who complete 2 VR sessions
Time frame: Up to 3 Months
Percentage of patients who complete 2 VR sessions will be calculated.
Proportion of patients reporting ease of use for VR sessions
Time frame: Up to 3 Months
Patients will be given a survey on their VR sessions to measure the ease of use and ability to provide useful information.
Proportion of overall adherence to radiation therapy
Time frame: Up to 3 Months
Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.
3 secondary outcomes
Change in state trait anxiety scale
Time frame: Up to 3 Months
Change in brief symptom inventory
Time frame: Up to 3 Months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI)
Time frame: Up to 3 Months
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 14 Feb 2024.
- 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.
Christina Henson, MD principal investigator
Stephenson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Session in people with Breast Cancer and Head and Neck Cancer, run by University of Oklahoma.
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 5 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 14 Feb 2024. 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?
Proportion of patients who complete 2 VR sessions (time frame: Up to 3 Months). The study lists 3 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 14 Feb 2024.