The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer
1 other identifier
observational
27
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 24, 2007
CompletedFirst Posted
Study publicly available on registry
January 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 30, 2017
January 1, 2017
9.1 years
December 24, 2007
January 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To examine the views of women about the provision of genetic risk information to their daughters.
conclusion of study
Study Arms (1)
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.
Interventions
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 Criteria
Memorial Sloan-Kettering Cancer Center (MSK) breast cancer patients seen by the clinical genetics service (CGS)and their daughters
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Monash Universitycollaborator
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Smita Banerjee, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2007
First Posted
January 8, 2008
Study Start
December 1, 2007
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
January 30, 2017
Record last verified: 2017-01