Completed

Methods in Education for Breast Cancer Genetics

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What is being tested

Genetic Education and Counseling

+ Genetic Education and Counseling

Other
Who is being recruted

Urogenital Diseases+16

+ Genital Diseases

+ Adnexal Diseases

From 18 to 100 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Phase 3
Interventional
Study Start: April 1999
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: December 12, 2019
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNational Cancer Institute (NCI)
Last updated: December 12, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

170 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Urogenital DiseasesGenital DiseasesAdnexal DiseasesBreast DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesSkin DiseasesUrogenital NeoplasmsSkin and Connective Tissue DiseasesFemale Urogenital DiseasesBreast NeoplasmsOvarian Neoplasms

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Group education and counseling

Group II

Active Comparator
Individual education and counseling

Study 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
CompletedOne Study Center