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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00588705
Other study ID # 07-063
Secondary ID
Status Completed
Phase N/A
First received December 24, 2007
Last updated January 27, 2017
Start date December 2007
Est. completion date January 2017

Study information

Verified date January 2017
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 12 Years to 20 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Monash University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Is a demonstration of the effectiveness of the module in changing the behavior of clinicians after taking part in the communication skills module. conclusion of study
Secondary To examine the views of women about the provision of genetic risk information to their daughters. conclusion of study
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