Methods in Education for Breast Cancer Genetics
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Ovarian Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/6/2019 |
| Start Date: | April 6, 1999 |
| End Date: | December 6, 2017 |
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.
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.
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.
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.
- INCLUSION CRITERIA:
At least one of the following:
Diagnosis of breast cancer, or DCIS prior to or at 45, or ovarian cancer prior to or at age
50;
Diagnosis of breast cancer with bilateral disease or multiple primaries or breast cancer
and ovarian cancer in the same individual;
Diagnosis of breast or ovarian cancer and one first or second degree relative with breast
cancer diagnosed prior to or at age 45, or ovarian cancer prior to or at age 50;
Diagnosis of breast or ovarian cancer and three relatives in the same lineage with breast
or ovarian cancer; each affected individual must be a first- or second-degree relative to
another of the affected individuals;
Diagnosis of breast or ovarian cancer and a first or second degree male relative with
breast cancer;
A woman of Ashkenazi Jewish descent who meets any of the above criteria, with specified
ages of onset of 50 for breast cancer and any age for ovarian cancer;
A male with breast cancer diagnosed at any age;
Documented BRCA mutation in the family.
All individuals must be able to give informed consent.
EXCLUSION CRITERIA:
Patients will be considered ineligible for any of the following reasons:
Any psychological disorder which may hinder the participant's ability to understand and
process the material, based on a psychiatric consultation.
Inable to return for 2 visits.
Age under 18 years old.
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