The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588705

Purpose

The purpose of this study is to first understand how MSKCC Clinical Genetics Service doctors talk to women with breast cancer about any genetic risks they might carry, and if they help women to think about what they might say, in turn, to their relatives, especially their daughters.

A second part of the study asks women for their opinions about when and how their daughters should be told about any genetic risks.

All of this will help us develop teaching methods to help our doctors improve the way they talk about genetic risk when women with breast cancer have adolescent daughters.

Condition	Intervention
Breast Cancer Counseling	Behavioral: focus group & questionaire

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Family-Based, Prospective
Official Title:	The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Is a demonstration of the effectiveness of the module in changing the behavior of clinicians after taking part in the communication skills module. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the views of women about the provision of genetic risk information to their daughters. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	66
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
focus group & questionaire The group will discuss its views about how and when to talk about the risk of getting breast cancer. The focus group will be video recorded and the video recorded material will be later transcribed and carefully analyzed. In addition you will be asked to answer questions about yourself, such as education and marital status.	Behavioral: focus group & questionaire The focus group will last about 90 minutes. However, your involvement in this study will last from the time you join until you read over the summary of what happened during the focus group and return your comments. This should be approximately 2 months. Patient will complete a questionnaire and we estimate total time for completion to be approximately 7 minutes.

Groups/Cohorts

Assigned Interventions

focus group & questionaire

The group will discuss its views about how and when to talk about the risk of getting breast cancer. The focus group will be video recorded and the video recorded material will be later transcribed and carefully analyzed. In addition you will be asked to answer questions about yourself, such as education and marital status.

Behavioral: focus group & questionaire

The focus group will last about 90 minutes. However, your involvement in this study will last from the time you join until you read over the summary of what happened during the focus group and return your comments. This should be approximately 2 months. Patient will complete a questionnaire and we estimate total time for completion to be approximately 7 minutes.

Eligibility

Ages Eligible for Study:	12 Years to 20 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Memorial Sloan-Kettering Cancer Center (MSK) breast cancer patients seen by the clinical genetics service (CGS)and their daughters

Criteria

Inclusion Criteria:

Women seen in the MSK CGS Service who have a diagnosis of breast cancer or
a family history of breast cancer and
have biological daughter(s) in the age range 12-20 years will be eligible to participate in Phase I & II.
Women who were consented to Phase I will automatically be eligible for Phase II.

Exclusion Criteria:

Women seen in the MSK CGS Service will be ineligible if they have no diagnosis of breast cancer and no family history of breast cancer,
do not have a biological daughter,
or have a biological daughter fewer than 12 or greater than 20 years(unless they were consented to Phase 1).
Women will be ineligible if they are not English speaking,
have intellectual or cognitive impairment,
or active mental illness rendering them incapable of giving informed consent, such as might occur with active psychosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588705

Contacts

Contact: David Kissane, MD		kissaned@mskcc.org
Contact: Richard Brown, PhD		brownr@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: David Kissane, MD kissaned@mskcc.org
Principal Investigator: David Kissane, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

David Kissane, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( David Kissane, MD )
Study ID Numbers:	07-063
Study First Received:	December 24, 2007
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00588705 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Daughters
Communication
genetic risk
Genetic Counseling

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009