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

This study has been withdrawn prior to enrollment.
(PI left)
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00530751
First received: September 13, 2007
Last updated: May 27, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Breast Cancer
Other: counseling intervention

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Patient Perspectives on Sharing Family Medical Histories

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Participants' perspectives and concerns regarding online genetic risk assessment or research [ Designated as safety issue: No ]
  • Identification of directions for future research into the ethics of online genetic risk assessment or research [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2007
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed 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.

  Eligibility

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

Primary care center

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
  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: NCT00530751

Locations
United States, Ohio
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
Geauga Regional Hospital
Chardonr, Ohio, United States, 44024
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center
Middleburgh Heights, Ohio, United States, 44130
UHHS Chagrin Highlands Medical Center
Orange Villager, Ohio, United States, 44122
University Suburban Health Center
South Euclid, Ohio, United States, 44121
UHHS Westlake Medical Center
Westlaker, Ohio, United States, 44145
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Christian Simon, PhD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Christian Simon, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00530751     History of Changes
Other Study ID Numbers: CASE1Z07, P30CA043703, CASE1Z07, CASE-1Z07-CC220
Study First Received: September 13, 2007
Last Updated: May 27, 2011
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014