CancerNCT01310829
Virtual Reality Intervention in Cancer Genetics
An observational study of Cancer and Prevention Harmful Effects, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this study is to evaluate a virtual reality-based intervention for training health care providers who are not genetics specialists to effectively communicate with and counsel patients regarding cancer genetics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Prevention Harmful Effects
- What is being tested?
- Questionnaires, Physiological Measurements and Virtual Reality Scene Viewing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to May 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Genetic counselors and genetic counseling students
Who may be able to join
- Genetic counselors: Board-eligible or board-certified genetic counselor
- Genetic counseling students: Currently enrolled and in good standing in an accredited genetic counseling degree program
- 18 years of age or older
Who cannot join
- 1. Non-English speaking
About this study
Official title: Developing Providers' Communication and Counseling Skills in Cancer Genetics Using Virtual Reality
The goal of this study is to evaluate a virtual reality-based intervention for training health care providers who are not genetics specialists to effectively communicate with and counsel patients regarding cancer genetics.
Read the detailed description
If you agree to take part in this study, you will complete questionnaires, have your physiological measurements recorded, and view virtual reality scenes.
Questionnaires:
You will fill out questionnaires before and after viewing the virtual reality scenes. Before viewing the virtual reality scenes, you will answer questions about your demographic, educational and professional background and about the likelihood of becoming engaged in a virtual environment. After viewing the virtual reality scenes, you will answer questions to evaluate the scenes. You also will be asked to provide additional comments about the virtual reality scenes during a brief interview. In total, these questionnaires should take about 30 minutes total to complete.
Physiological Measurements:
Your heart rate and the amount you sweat will be recorded during the virtual reality scene (described below) by applying small sensors to your skin.
After you have completed the first set of questionnaires, you will sit in a recliner and the sensors will be placed on your rib cage and hand. The sensors that measure heart rate will be placed in the following locations: your lower left rib cage, just under your right collar bone, and just under your left collar bone. The sensors that measure the amount you sweat will be placed on the palm of your hand.
The Virtual Reality Scenes:
You will sit in a recliner and be asked to put on a virtual reality helmet, which has goggles and noise-cancelling headphones. You will be told how to wear the helmet and use the hand-held controller.
You will first view a sample virtual reality scene to help orient you to the technology. The experience of virtual reality may involve multiple senses. For example, you may hear, smell, and feel sensations (such as mild vibrations) that are associated with the scenes you are viewing.
After you become comfortable using the technology, you will view a virtual reality scenario that depicts a typical session in cancer genetic counseling. The scenario will depict a virtual patient who is being seen for genetic counseling. You will be encouraged to speak to and interact with the virtual patient as you would with a real patient. The interaction with the virtual patient will be recorded. It is estimated that you will spend about 30 minutes in the genetic counseling scene with the virtual patient.
After the scene has ended, the equipment and sensors will be removed, and you will be asked to complete the second set of questionnaires and the brief interview.
It is expected that it will take up to 2 hours to complete all study procedures.
This is an investigational study.
Up to 21 people will take part in this study at M. D. Anderson.
- Conditions
- Cancer, Prevention Harmful Effects
- Being tested
- Questionnaires, Physiological Measurements, Virtual Reality Scene Viewing
- Keywords
- Genetic counselor, Genetic counseling degree program, Genetic counseling students, Virtual reality-based intervention, VR, Genetic counseling, hereditary cancers, Questionnaires, Physiological measurements, Skin sensors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Survey
Questionnaires completed before and after viewing virtual reality scenes, taking about 30 minutes to complete.
Physiological MeasurementsBehavioural
Small sensors applied to skin will measure heart rate and sweat amounts while participants view a virtual reality scene.
Virtual Reality Scene ViewingBehavioural
Also called VR technology
Prototype virtual reality application that demonstrates a provider-patient communication scenario commonly encountered in genetic counseling for hereditary cancers.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Board-eligible or board-certified genetic counselors and students evaluate a virtual reality-based intervention using questionnaires and physiological measurements. Receives: Behavioral: Questionnaires; Behavioral: Physiological Measurements; Behavioral: Virtual Reality Scene Viewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proof of concept for Virtual Reality (VR) Technology as Training Method About Hereditary cancer risk and genetic testing
Proof of concept for VR application established if VR prototype successfully evokes a sense of presence and co-presence (measured by the PQ and CPQ questionnaires, respectively). Responses to the PQ and CPQ given on a 7-point scale, with higher scores indicating higher degrees of presence and co-presence where mean scores above 4 considered high degree of presence and co-presence.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, PHD, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310829
- Sponsor's protocol ID
- 2009-0456
- Status last verified
- May 2016
- First submitted
- 7 Mar 2011
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Providers' Communication and Counseling Skills in Cancer Genetics Using Virtual Reality
- ClinicalTrials.gov ID
- NCT01310829
- Acronym / sponsor ID
- 2009-0456
- Conditions
- Cancer, Prevention Harmful Effects
- Keywords
- Genetic counselor, Genetic counseling degree program, Genetic counseling students, Virtual reality-based intervention, VR, Genetic counseling, hereditary cancers, Questionnaires
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 Mar 2011 (estimated)
- 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 goal of this study is to evaluate a virtual reality-based intervention for training health care providers who are not genetics specialists to effectively communicate with and counsel patients regarding cancer genetics.
Detailed description
If you agree to take part in this study, you will complete questionnaires, have your physiological measurements recorded, and view virtual reality scenes.
Questionnaires:
You will fill out questionnaires before and after viewing the virtual reality scenes. Before viewing the virtual reality scenes, you will answer questions about your demographic, educational and professional background and about the likelihood of becoming engaged in a virtual environment. After viewing the virtual reality scenes, you will answer questions to evaluate the scenes. You also will be asked to provide additional comments about the virtual reality scenes during a brief interview. In total, these questionnaires should take about 30 minutes total to complete.
Physiological Measurements:
Your heart rate and the amount you sweat will be recorded during the virtual reality scene (described below) by applying small sensors to your skin.
After you have completed the first set of questionnaires, you will sit in a recliner and the sensors will be placed on your rib cage and hand. The sensors that measure heart rate will be placed in the following locations: your lower left rib cage, just under your right collar bone, and just under your left collar bone. The sensors that measure the amount you sweat will be placed on the palm of your hand.
The Virtual Reality Scenes:
You will sit in a recliner and be asked to put on a virtual reality helmet, which has goggles and noise-cancelling headphones. You will be told how to wear the helmet and use the hand-held controller.
You will first view a sample virtual reality scene to help orient you to the technology. The experience of virtual reality may involve multiple senses. For example, you may hear, smell, and feel sensations (such as mild vibrations) that are associated with the scenes you are viewing.
After you become comfortable using the technology, you will view a virtual reality scenario that depicts a typical session in cancer genetic counseling. The scenario will depict a virtual patient who is being seen for genetic counseling. You will be encouraged to speak to and interact with the virtual patient as you would with a real patient. The interaction with the virtual patient will be recorded. It is estimated that you will spend about 30 minutes in the genetic counseling scene with the virtual patient.
After the scene has ended, the equipment and sensors will be removed, and you will be asked to complete the second set of questionnaires and the brief interview.
It is expected that it will take up to 2 hours to complete all study procedures.
This is an investigational study.
Up to 21 people will take part in this study at M. D. Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | – | Behavioral: Questionnaires, Behavioral: Physiological Measurements, Behavioral: Virtual Reality Scene ViewingBoard-eligible or board-certified genetic counselors and students evaluate a virtual reality-based intervention using questionnaires and physiological measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Genetic counselors and genetic counseling students
Key inclusion criteria (3 listed)
- Genetic counselors: Board-eligible or board-certified genetic counselor
- Genetic counseling students: Currently enrolled and in good standing in an accredited genetic counseling degree program
- 18 years of age or older
Key exclusion criteria (1 listed)
- 1. Non-English speaking
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 |
|---|---|---|
| QuestionnairesAlso: SurveyQuestionnaires completed before and after viewing virtual reality scenes, taking about 30 minutes to complete. | Behavioural | Virtual Reality |
| Physiological MeasurementsSmall sensors applied to skin will measure heart rate and sweat amounts while participants view a virtual reality scene. | Behavioural | Virtual Reality |
| Virtual Reality Scene ViewingAlso: VR technologyPrototype virtual reality application that demonstrates a provider-patient communication scenario commonly encountered in genetic counseling for hereditary cancers. | Behavioural | Virtual Reality |
Primary outcome
Proof of concept for Virtual Reality (VR) Technology as Training Method About Hereditary cancer risk and genetic testing
Time frame: 2 hours
Proof of concept for VR application established if VR prototype successfully evokes a sense of presence and co-presence (measured by the PQ and CPQ questionnaires, respectively). Responses to the PQ and CPQ given on a 7-point scale, with higher scores indicating higher degrees of presence and co-presence where mean scores above 4 considered high degree of presence and co-presence.
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 26 May 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Susan Peterson, PHD, MPH principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Prevention Harmful Effects, run by M.D. Anderson Cancer Center.
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 3 inclusion and 1 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 26 May 2016. 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?
Proof of concept for Virtual Reality (VR) Technology as Training Method About Hereditary cancer risk and genetic testing (time frame: 2 hours). 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 26 May 2016.