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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00530751
Other study ID # CASE1Z07
Secondary ID P30CA043703CASE1
Status Withdrawn
Phase N/A
First received September 13, 2007
Last updated October 1, 2015
Start date March 2007

Study information

Verified date October 2015
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: Learning about the concerns that individuals may have about providing family medical history online for genetic risk assessment or research may help doctors plan future research.

PURPOSE: This clinical trial is studying views on sharing family medical history in healthy women undergoing mammograms or breast evaluation.


Description:

OBJECTIVES:

- To gain an initial understanding of the ethical, family, and related concerns that individuals may have when offered the option of providing family medical history online for genetic risk assessment or research.

- To identify specific directions for future research into the ethics of online genetic risk assessment.

OUTLINE: Participants undergo a 45-60 minute interview to assess their attitudes and concerns about providing family medical history online for genetic risk assessment or research. Participants' feelings about whether or not to use an online genetic assessment tool (i.e., Genetic Risk Easy Assessment Tool [GREAT]) are explored. The GREAT allows for the electronic creation, analysis, and dissemination of family histories of individuals who may be at risk for various types of cancer. Key factors influencing a participant's use of the tool, including concerns about confidentiality, privacy, informed consent, access to risk information, and security of online family history databases, are explored. Ethical issues regarding communication and agreement among family members on disclosing family medical history are also discussed.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Healthy women undergoing mammograms or being evaluated for a breast concern at the University Hospitals Breast Center

PATIENT CHARACTERISTICS:

- Able to speak English

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Family-Based, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
counseling intervention
Participants undergo a 45-60 minute interview to assess their attitudes and concerns about providing family medical history online for genetic risk assessment or research. Participants' feelings about whether or not to use an online genetic assessment tool (i.e., Genetic Risk Easy Assessment Tool [GREAT]) are explored.

Locations

Country Name City State
United States Mercy Cancer Center at Mercy Medical Center Canton Ohio
United States Geauga Regional Hospital Chardonr Ohio
United States Lake/University Ireland Cancer Center Mentor Ohio
United States Southwest General Health Center Middleburgh Heights Ohio
United States UHHS Chagrin Highlands Medical Center Orange Villager Ohio
United States University Suburban Health Center South Euclid Ohio
United States UHHS Westlake Medical Center Westlaker Ohio

Sponsors (2)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participants' perspectives and concerns regarding online genetic risk assessment or research No
Primary Identification of directions for future research into the ethics of online genetic risk assessment or research No
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