|
Methods in Education for Breast Cancer Genetics Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Methods in Education for Breast Cancer Genetics conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Methods in Education for Breast Cancer Genetics Clinical research trials and Methods in Education for Breast Cancer Genetics healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Methods in Education for Breast Cancer Genetics. Methods in Education for Breast Cancer Genetics Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Methods in Education for Breast Cancer Genetics clinical trial. Test subjects typically receive the most effective healthcare possible for their Methods in Education for Breast Cancer Genetics condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Methods in Education for Breast Cancer Genetics  Methods in Education for Breast Cancer Genetics
Methods in Education for Breast Cancer Genetics
For Condition: Breast Neoplasm,Ovarian Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 170
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990081; 99-C-0081
Study Start Date: April 3, 1999
Record last reviewed: March 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001806
Other Ovarian Cancer Studies:
1. Gemzar (gemcitabine) and Alimta (pemetrexed) in the Treatment of Patients with Recurrent Platinum-Sensitive and Platinum-Resistant Ovarian or Peritoneal Cancer
2. A clinical efficacy study of an oral tyrosine kinase inhibitor of VEGFR-2 to treat recurrent or persistent small-volume epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer
3. A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833
4. Methods in Education for Breast Cancer Genetics
5. Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian Cancer
Related Studies:
Other Ovarian Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Methods in Education for Breast Cancer Genetics
|
|
|
|
|
|
|
|
