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4R for Guideline Indicated BRCA Testing of Newly Diagnosed Breast Cancer Patients

This study is currently recruiting participants.
Verified March 2013 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Julian Schink, Northwestern University
ClinicalTrials.gov Identifier:
NCT01320540
First received: March 18, 2011
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

Currently, many breast cancer patients with a positive family history receive information about BRCA testing after 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 this patient population shortly after receiving the breast cancer diagnosis and in ample time to be able 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 initial visit, develop a standardized BRCA patient education handout, enlist health care providers to insure the information is delivered to the appropriate patient population shortly after diagnosis, 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 prior to their surgical decision will shift BRCA testing to before definitive breast cancer surgery 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 diagnosis. 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:

U.S. FDA Resources

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 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Newly diagnosed breast cancer 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
  • Diagnosed with invasive breast cancer who are being 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 with invasive breast cancer who:

  • 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
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: Julian Schink, MD            
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Julian Schink, MD Northwestern University
  More Information

No publications provided

Responsible Party: Julian Schink, Division Chief, Gynecologic Oncology, Northwestern University
ClinicalTrials.gov Identifier: NCT01320540     History of Changes
Other Study ID Numbers: STU00041300
Study First Received: March 18, 2011
Last Updated: March 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Disease Susceptibility
Genetic Predisposition to Disease
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013