Breast CancerNCT00530751
Views on Sharing Family Medical History in Healthy Women Undergoing Mammograms or Breast Evaluation
An observational study of Breast Cancer, run by Case Comprehensive Cancer Center at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- counseling intervention
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2007to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care center
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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, 44708
Geauga Regional Hospital
Chardonr, Ohio, 44024
Lake/University Ireland Cancer Center
Mentor, Ohio, 44060
Southwest General Health Center
Middleburg Heights, Ohio, 44130
UHHS Chagrin Highlands Medical Center
Orange Villager, Ohio, 44122
University Suburban Health Center
South Euclid, Ohio, 44121
UHHS Westlake Medical Center
Westlaker, Ohio, 44145
About this study
Official title: Patient Perspectives on Sharing Family Medical Histories
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- counseling intervention
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' perspectives and concerns regarding online genetic risk assessment or research
Identification of directions for future research into the ethics of online genetic risk assessment or research
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
Why it stopped: PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Christian Simon, PhD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530751
- Sponsor's protocol ID
- CASE1Z07
- Other IDs
- P30CA043703, CASE1Z07, CASE-1Z07-CC220
- Status last verified
- Oct 2015
- First submitted
- 13 Sep 2007
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perspectives on Sharing Family Medical Histories
- ClinicalTrials.gov ID
- NCT00530751
- Acronym / sponsor ID
- CASE1Z07
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counseling interventionParticipants 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. | Other | – |
Primary outcome
Participants' perspectives and concerns regarding online genetic risk assessment or research
Identification of directions for future research into the ethics of online genetic risk assessment or research
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Simon, PhD study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Case Comprehensive Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' perspectives and concerns regarding online genetic risk assessment or research. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.