Reactions to Disease Risk Information | NCT00774254

Studies
Reactions to Disease Risk Information

NCT00774254

Sponsor

National Human Genome Research Institute (NHGRI)

Status

Completed

Last Update Posted

Oct 1, 2024Actual

Enrollment

132Actual

Phase

Not Applicable

Conditions

Cancer

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
09-HG-0009

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2009Actual

Primary Completion Date

Sep 30, 2010Actual

Completion Date

Sep 30, 2010Actual

First Submitted Date

Oct 16, 2008

First Submission Date that Met QC Criteria

Oct 16, 2008

First Posted Date

Oct 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2024

Last Update Posted Date

Oct 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Label	Type	Description	Intervention Names
A	Experimental		Behavioral: A Behavioral: B

Name	Type	Description	Arm Group Labels	Other Names
A	Behavioral	Intervention	A
B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk Perception	The objective of the proposed study is to examine a cognitive bias known as anchoring and adjustment that may occur during provider-patient interactions, such as during provision of risk information for common, complex diseases that have both genetic and behavioralcomponents.	ongoing

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:
Self-reported ability to speak, read, and write in English.
Self identifying as African-American or Black
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Persky, Ph.D.	National Human Genome Research Institute (NHGRI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10633974	Background	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. doi: 10.3758/bf03200735.
15018671	Background	Bailenson JN, Blascovich J, Beall AC, Loomis JM. Interpersonal distance in immersive virtual environments. Pers Soc Psychol Bull. 2003 Jul;29(7):819-33. doi: 10.1177/0146167203029007002.

ID	Term
D009369	Neoplasms
D003142	Communication