Methods in Education for Breast Cancer Genetics
Condition: Breast Cancer; Ovarian Cancer
MeSH terms: Breast Neoplasms; Ovarian Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      In 1997, the Genetics Department of the NCI Medicine Branch helped establish a breast cancer
      genetics program at the National Naval Medical Center s Breast Care Center. Genetic
      education, counseling, and germline testing for BRCA1 and BRCA2, two genes which confer
      increased lifetime risks for breast and ovarian cancer, were offered under a Navy
      IRB-approved study. Sixty participants received education and counseling on that protocol, 49
      of whom chose to have genetic testing. The education and counseling, provided by oncology
      nurses trained in cancer genetics, focused on preparing participants to make well-informed
      decisions about testing. Included were information on cancer and genetics; hereditary
      breast/ovarian cancer syndrome; risks, benefits and limitations of BRCA1/BRCA2 testing; and
      screening and risk reduction options for high-risk individuals. Through our experience with
      this study, we devised two different methods of providing this information. Both of these
      methods were well received and appear to be equally effective, as measured by knowledge
      assessments before and after the sessions and subjective evaluation by the participants. We
      will now study them in a randomized fashion in the current protocol, to better evaluate
      whether one method is preferable. Ultimately we hope to be able to make recommendations that
      will allow for access to genetic education and counseling for more individuals in a more cost
      efficient manner.
    

Detailed description: 
      In October 1995 the National Naval Medical Center opened the only Department of Defense
      funded Breast Care Center (BCC). Within less than one year the Center was seeing 100 - 200
      new patients per week and making 10 - 20 new diagnoses of breast cancer per month. In 1997 we
      began conducting germline testing for BRCA1 and BRCA2 under an approved Navy IRB study. To
      date, 51 individuals have enrolled into the Education and Counseling component, and 42
      individuals have elected to receive germline testing. Early on it became apparent that a more
      time efficient approach to education and counseling would be required if access to
      information on breast cancer genetics was to be made available to a larger population.
      Traditionally, education and counseling has been offered on a one to one basis prior to
      germline testing. Often, hours are spent with an individual. At some centers, multiple visits
      are standard. Not only is there a shortage of health care providers trained in cancer
      genetics, but even if there were an abundance of trained providers, the time and cost, as
      well as need for efficiency would preclude this type of approach. Thus, this approach is not
      applicable to most health care delivery systems. We began offering education in small groups
      approximately 18 months ago, using the same informational content that we use in our one to
      one sessions. Based on preliminary, nonrandomized results, there appeared to be no difference
      in learning and general patient satisfaction based on results of pre- and post-test
      administered before and after the education. It was our contention that group education is
      equivalent, and in some situations better than individual education. Therefore, we will
      conduct a randomized trial designed to test equivalence between individual and group
      education.
    

Intervention name(s): Genetic Education and Counseling; Genetic Education and Counseling
Intervention type(s): Other; Other
Intervention description(s): Group Education and Counseling; Individual Education and Counlseing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Genetic Testing; Genetic Counseling; BRCA1/BRCA2; Genetic Education; Informed Consent; Breast Cancer; Ovarian Cancer; Known Family Mutation