Methods in Education for Breast Cancer Genetics
Genetic Education and Counseling
+ Genetic Education and Counseling
Urogenital Diseases+16
+ Genital Diseases
+ Adnexal Diseases
Services Research Study
Summary
Study start date: April 6, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.170 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Walter Reed National Medical Center
Bethesda, United StatesOpen Walter Reed National Medical Center in Google Maps