Overview

This trial is active, not recruiting.

Conditions breast cancer, counseling
Treatment focus group & questionaire
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Monash University
Start date December 2007
End date December 2016
Trial size 27 participants
Trial identifier NCT00588705, 07-063

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model family-based
Time perspective prospective
Arm
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.
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
To examine the views of women about the provision of genetic risk information to their daughters.
time frame: conclusion of study

Eligibility Criteria

Female participants from 12 years up to 20 years old.

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.

Additional Information

Official title The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer
Principal investigator Smita Banerjee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.