Reactions to Disease Risk Information - Full Text View

Sponsored by:	National Human Genome Research Institute (NHGRI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00774254

Purpose

This study is part of an effort to learn about interactions between doctors and patients. The study will use virtual reality technology to examine how patients and doctors interact when they discuss disease risks.

Men and women between the ages of 25 and 40 who have access to the Internet and were born and raised in the United States may be eligible for this study. Participants will be recruited from the Washington D.C.

area.

Participants undergo the following procedures:

Complete an online questionnaire about their health-related background, family health history, cancer risk perceptions, and demographic information (e.g., age, marital status, education, etc.).
Participate in activities in a virtual reality environment in which they interact with a virtual doctor in a virtual clinical scenario. For this experiment, participants wear a head-mounted display that allows them to see the virtual world images.
Fill out a second questionnaire after completing the virtual reality activities. This questionnaire includes information on the participants' virtual reality experience, the information provided in the experience, and questions about themselves and their background.

Condition
Cancer

Study Type:	Observational
Official Title:	Participant Reactions to Disease Risk Information

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	192
Study Start Date:	October 2008
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Detailed Description:

This study will investigate interactions between doctors and patients regarding risks of common, complex diseases using virtual reality technology.

Men and women between the ages of 25 and 40 who have access to the Internet and were born and raised in the United States may be eligible for this study. Participants will be recruited from the Washington D.C.

area.

Study subjects complete two phases. The first phase is to complete an online questionnaire about their heath-related background, family health history, cancer risk perceptions, and demographic information using a secure survey website. The second phase involves interacting with a virtual doctor in a virtual environment clinical scenario, followed by completion of a second questionnaire. While in the virtual environment, participants wear a head-mounted video unit that allows them to see elements of the environment. The activities in the virtual environment take about 15 minutes. The total time for the study is about 60 minutes.

Eligibility

Ages Eligible for Study:	25 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:
Self-reported ability to speak, read, and write in English.
Having been born and raised in the U.S.
Not having been diagnosed with any of the diseases used in the experiment.
Being between 25 and 40 years of age.
Having access to the Internet.
Both men and women will be included in the study.

EXCLUSION CRITERIA:

Individuals below the age of 25 because they might not yet have completed their education and those above the age of 40 because they might have less familiarity with interactive technologies than younger individuals.
Because the study will utilize virtual reality technology, individuals who are particularly susceptible to motion sickness will be excluded.
All individuals with epilepsy, low vision, hearing problems, and vestibular disorders (e.g., vertigo) will be excluded from the study for safety reasons.
We will re-screen for safety exclusion criteria when participants arrive to participate in the in-person portion of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774254

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Human Genome Research Institute (NHGRI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Loomis JM, Blascovich JJ, Beall AC. Immersive virtual environment technology as a basic research tool in psychology. Behav Res Methods Instrum Comput. 1999 Nov;31(4):557-64. Review.

Bailenson JN, Blascovich J, Beall AC, Loomis JM. Interpersonal distance in immersive virtual environments. Pers Soc Psychol Bull. 2003 Jul;29(7):819-33.

Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82.

Study ID Numbers:	090009, 09-HG-0009
Study First Received:	October 16, 2008
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00774254 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Health Disparities
Risk Communication
Numeracy
Doctor-Patient Communication

Virtual Reality Technology
Communication
Doctor-Patient Communication

ClinicalTrials.gov processed this record on September 03, 2009