4R for Guideline Indicated BRCA Testing of Breast Center Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Melissa Simon, Northwestern University
ClinicalTrials.gov Identifier:
NCT01320540
First received: March 18, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

Currently, many breast center patients with a positive family history receive information about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery or at a time point that does not allow them to use testing results in making their surgical decision. Diagnostics, decisions and interventions are often out of sequence, resulting in test information not available in time for decisions. Tests are often repeated. Decisions and interventions are delayed, are not understood by breast cancer patients or proceed without the test information, resulting in suboptimal care and resource waste (Donaldson MS. 2005, Katz SJ 2007, IOM 2001).

In this study, BRCA testing information will be delivered to patients at the point of breast imaging. For patients that are diagnosed with breast cancer, this provides ample time to use the test results in making their surgical decision, if they elect to be tested. The investigators will work with health care providers to insure family history data are collected at the breast imaging visit, develop a standardized BRCA patient education handout, enlist health care providers to insure the information is delivered to the appropriate patient population, and coordinate scheduling with genetic counseling services to insure patients are promptly seen.

The investigators hypothesis is that an intervention of providing patients indicated for genetic/familial risk with timely information and opportunity to access genetic counseling during breast imaging will shift BRCA testing to before definitive breast cancer surgery, for patients with a breast cancer diagnosis, and could impact surgical decisions. The investigators will identify barriers to this intervention from the perspective of patients, physicians, nurses, and genetic counselors. The investigators will then adjust the intervention to overcome the barriers and will test the intervention at the point where genetic/familial risk assessment based on NCCN guidelines is (or should be) conducted at breast imaging. If indicated, patients will be provided information and will be referred to genetic counseling to consider BRCA tests.


Condition
Newly Diagnosed Carcinoma of Breast
Genetic Predisposition to Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 4R (Right Information and Right Care to the Right Patient at the Right Time) for Guideline Indicated BRCA Genetic Assessment of Breast Center Patients

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • The timing of genetic testing in regards to what kind of surgery was performed [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    To test an intervention for breast cancer patients with familial/genetic risk by obtaining data on 83 women with breast cancer who were tested before the intervention was implemented and comparing their outcomes to 83 women with breast cancer who were treated after the intervention was implemented. The primary endpoint is the timing of BRCA testing relative to (before or after) definitive breast cancer surgery and the surgical decision (lumpectomy, mastectomy, bi-lateral mastectomy).

  • The timing of genetic testing in regards to what kind of surgery was performed [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To test an intervention for breast center patients with familial/genetic risk by obtaining data on 2,000 women who consented and participated in the genetics assessment screening survey, with a sub-cohort of 300 that may benefit from genetic assessment and/or testing based on the screening tool results.


Secondary Outcome Measures:
  • Impact of the intervention [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    To assess the care process impact of the intervention on patients and provider staff through pre and post intervention interviews. The process impact will be assessed by comparing the questionnaires from the pre and post intervention interviews in 6 patients and 12 providers.


Estimated Enrollment: 202
Study Start Date: March 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast Center Patients
Patients newly diagnosed with breast cancer who did or did not have genetic testing (retrospectively and prospectively).
Staff from the Lynn Sage Comprehensive Breast Cancer Center
Members of the Northwestern staff to include but not limited the Lynn Sage Comprehensive Breast Cancer Center and/or Breast Cancer Genetics Program provider staff (including physicians, nurses, schedulers, physician assistants and/or genetic counselors).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women newly diagnosed with breast cancer

Criteria

Inclusion Criteria:

Retrospective chart review of 83 breast cancer patients:

  • Female
  • Age 18 and older
  • Diagnosed with invasive breast cancer at Northwestern between 07/01/2008 and 06/30/2010

Prospective chart review of 83 patients:

  • Female
  • Age 18 and older
  • Diagnosed with invasive breast cancer at Northwestern between 03/01/2011 and 05/31/2012

For patient interviews:

  • Female
  • Age 18 and older
  • Are not inpatients
  • Patients seen at the Lynn Sage Comprehensive Breast Center

For staff interviews:

Members of the Northwestern staff to include but not limited the Lynn Sage Comprehensive Breast Cancer Center and/or Breast Cancer Genetics Program provider staff (including physicians, nurses, schedulers, physician assistants and/or genetic counselors)

Exclusion Criteria:

  • Under 18 years of age

To test the intervention, patients seen at the breast center:

  • Are female
  • Are age 18 and older
  • Are not institutionalized
  • Are being seen at the Lynn Sage Comprehensive Breast Center
  • Have a positive family history per NCCN guidelines on genetic/familial high risk assessment for breast and ovarian cancer

Exclusion Criteria:

  • Under 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320540

Contacts
Contact: Doreine Carson 312-472-4681 d-carson@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Melissa Simon, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Melissa Simon, MD Northwestern University
  More Information

No publications provided

Responsible Party: Melissa Simon, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01320540     History of Changes
Other Study ID Numbers: STU00041300
Study First Received: March 18, 2011
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Breast Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014