Methods in Education for Breast Cancer Genetics

NCT00001806 | Completed Phase 3

• 2 other identifiers: 99008199-C-0081
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Ovarian Cancer

Keywords

Genetic Testing; Genetic Counseling; BRCA1/BRCA2; Genetic Education; Informed Consent; Breast Cancer; Ovarian Cancer; Known Family Mutation

Outcome Measures

Primary Outcomes (2)

• Impact of Events Scale

  Baseline, 3, 6, and 12 months

• Breast Cancer Genetics Knowledge Score

  Baseline, 3, 6, and 12 months

Study Arms (2)

Group

EXPERIMENTAL

Group education and counseling

Other: Genetic Education and Counseling

Individual

ACTIVE COMPARATOR

Individual education and counseling

Other: Genetic Education and Counseling

Interventions

Genetic Education and Counseling OTHER

Group Education and Counseling

Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Walter Reed National Medical Center

Bethesda, Maryland, 20301, United States

Location

Related Publications (3)

• Statement of the American Society of Clinical Oncology: genetic testing for cancer susceptibility, Adopted on February 20, 1996. J Clin Oncol. 1996 May;14(5):1730-6; discussion 1737-40. doi: 10.1200/JCO.1996.14.5.1730.

  PMID: 8622094 BACKGROUND

• Statement of the American Society of Human Genetics on genetic testing for breast and ovarian cancer predisposition. Am J Hum Genet. 1994 Nov;55(5):i-iv. No abstract available.

  PMID: 7977337 BACKGROUND

• Hoskins KF, Stopfer JE, Calzone KA, Merajver SD, Rebbeck TR, Garber JE, Weber BL. Assessment and counseling for women with a family history of breast cancer. A guide for clinicians. JAMA. 1995 Feb 15;273(7):577-85.

  PMID: 7837392 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Fanconi Anemia, Complementation Group D1

Interventions

Counseling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kathleen Calzone, R.N.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: April 6, 1999
• Primary Completion: December 6, 2017
• Study Completion: December 6, 2017
• Last Updated: December 12, 2019

Record last verified: 2017-12-06

Locations

US (1)