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The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Monash University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588705
First received: December 24, 2007
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 27
Study Start Date: December 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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.

  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

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Monash University
Investigators
Principal Investigator: Carma Bylund, PhD 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
ClinicalTrials.gov Identifier: NCT00588705     History of Changes
Other Study ID Numbers: 07-063
Study First Received: December 24, 2007
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Daughters
Communication
genetic risk
Genetic Counseling

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

ClinicalTrials.gov processed this record on October 17, 2012