Views on Sharing Family Medical History in Healthy Women Undergoing Mammograms or Breast Evaluation

NCT ID: NCT00530751

Last Updated: 2015-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Principal Investigators

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Christian Simon, PhD

Role: STUDY_CHAIR

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Locations

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Mercy Cancer Center at Mercy Medical Center

Canton, Ohio, United States

Site Status

Geauga Regional Hospital

Chardonr, Ohio, United States

Site Status

Lake/University Ireland Cancer Center

Mentor, Ohio, United States

Site Status

Southwest General Health Center

Middleburg Heights, Ohio, United States

Site Status

UHHS Chagrin Highlands Medical Center

Orange Villager, Ohio, United States

Site Status

University Suburban Health Center

South Euclid, Ohio, United States

Site Status

UHHS Westlake Medical Center

Westlaker, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://clinicaltrials.gov/ct2/show/NCT00530751?term=NCT00530751&rank=1

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

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P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE1Z07

Identifier Type: OTHER

Identifier Source: secondary_id

CASE-1Z07-CC220

Identifier Type: -

Identifier Source: secondary_id

CASE1Z07

Identifier Type: -

Identifier Source: org_study_id

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