Methods in Education for Breast Cancer Genetics
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ClinicalTrials.gov Identifier: NCT00001806 |
Recruitment Status
:
Completed
First Posted
: November 4, 1999
Last Update Posted
: April 20, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Ovarian Cancer | Other: Genetic Education and Counseling | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 170 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Methods in Education for Breast Cancer Genetics |
Study Start Date : | April 6, 1999 |
Actual Primary Completion Date : | December 6, 2017 |
Actual Study Completion Date : | December 6, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Group
Group education and counseling
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Other: Genetic Education and Counseling
Group Education and Counseling
|
Active Comparator: Individual
Individual education and counseling
|
Other: Genetic Education and Counseling
Individual Education and Counlseing
|
- Impact of Events Scale [ Time Frame: Baseline, 3, 6, and 12 months ]
- Breast Cancer Genetics Knowledge Score [ Time Frame: Baseline, 3, 6, and 12 months ]

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001806
United States, Maryland | |
Walter Reed National Medical Center | |
Bethesda, Maryland, United States, 20301 |
Principal Investigator: | Kathleen Calzone, R.N. | National Cancer Institute (NCI) |
Publications:
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00001806 History of Changes |
Obsolete Identifiers: | NCT00019877 |
Other Study ID Numbers: |
990081 99-C-0081 |
First Posted: | November 4, 1999 Key Record Dates |
Last Update Posted: | April 20, 2018 |
Last Verified: | December 6, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Genetic Testing Genetic Counseling BRCA1/BRCA2 Genetic Education |
Informed Consent Breast Cancer Ovarian Cancer Known Family Mutation |
Additional relevant MeSH terms:
Breast Neoplasms Ovarian Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Endocrine Gland Neoplasms |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |