Virtual Reality Intervention in Cancer Genetics

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01310829
First received: March 7, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Cancer
Prevention Harmful Effects
Behavioral: Questionnaires
Behavioral: Physiological Measurements
Behavioral: Virtual Reality Scene Viewing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing Providers' Communication and Counseling Skills in Cancer Genetics Using Virtual Reality

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Proof of concept for Virtual Reality (VR) Technology as Training Method About Hereditary cancer risk and genetic testing [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 21
Study Start Date: February 2011
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Virtual Reality
Board-eligible or board-certified genetic counselors and students evaluate a virtual reality-based intervention using questionnaires and physiological measurements.
Behavioral: Questionnaires
Questionnaires completed before and after viewing virtual reality scenes, taking about 30 minutes to complete.
Other Name: Survey
Behavioral: Physiological Measurements
Small sensors applied to skin will measure heart rate and sweat amounts while participants view a virtual reality scene.
Behavioral: Virtual Reality Scene Viewing
Prototype virtual reality application that demonstrates a provider-patient communication scenario commonly encountered in genetic counseling for hereditary cancers.
Other Name: VR technology

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Genetic counselors and genetic counseling students

Criteria

Inclusion Criteria:

  1. Genetic counselors: Board-eligible or board-certified genetic counselor
  2. Genetic counseling students: Currently enrolled and in good standing in an accredited genetic counseling degree program
  3. 18 years of age or older

Exclusion Criteria:

1. Non-English speaking

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310829

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Susan Peterson, PHD, MPH UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01310829     History of Changes
Other Study ID Numbers: 2009-0456
Study First Received: March 7, 2011
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Genetic counselor
Genetic counseling degree program
Genetic counseling students
Virtual reality-based intervention
VR
Genetic counseling
hereditary cancers
Questionnaires
Physiological measurements
Skin sensors

ClinicalTrials.gov processed this record on August 27, 2014