NCT00588705

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

9.1 years

First QC Date

December 24, 2007

Last Update Submit

January 27, 2017

Conditions

Keywords

DaughtersCommunicationgenetic riskGenetic Counseling

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.

Behavioral: focus group & questionaire

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.

focus group & questionaire

Eligibility Criteria

Age12 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsCommunication

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Smita Banerjee, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

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

Locations