Methods in Education for Breast Cancer Genetics

December 11, 2019 updated by: National Cancer Institute (NCI)
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20301
        • Walter Reed National Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group
Group education and counseling
Other: Genetic Education and Counseling
Group Education and Counseling
Other: Genetic Education and Counseling
Individual Education and Counlseing
Active Comparator: Individual
Individual education and counseling
Other: Genetic Education and Counseling
Group Education and Counseling
Other: Genetic Education and Counseling
Individual Education and Counlseing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Impact of Events Scale
Time Frame: Baseline, 3, 6, and 12 months
Baseline, 3, 6, and 12 months
Breast Cancer Genetics Knowledge Score
Time Frame: Baseline, 3, 6, and 12 months
Baseline, 3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathleen Calzone, R.N., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 1999

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 1999

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 6, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 990081
  • 99-C-0081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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