Adherence to Intensive Surveillance for Hereditary Breast Cancer

NCT00582803 | Completed

• 1 other identifier: 03-059
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Women with strong family histories of breast cancer are at increased risk to have breast cancer. Women whose close relatives have had breast cancer often have more breast cancer screening than other women their age. To increase the chance that any breast cancer will be caught early, women at risk often take part in special screening programs. These programs involve more frequent visits to the doctor for breast exams, yearly mammography, and new types of exam like breast Magnetic Resonance Imaging (MRI). Studies are going on to find out whether these programs are better than standard screening. The purpose of this study is to find out how these programs impact women's quality of life. The study will also try to learn what factors make it hard to take part in the programs. We hope to be able to design new programs that are easier to follow.

Conditions

Breast Cancer

Keywords

breast cancer; germline mutation; BRCA1; BRCA2; family history; genetic testing; unaffected women over age 25 who are at elevated risk for; breast cancer by virtue by a hereditary predisposition

Outcome Measures

Primary Outcomes (1)

• cognitive-affective mediating units that are likely to be involved in health information processing and the execution of health-protective behavior

  5 years 7 months

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

unaffected women over age 25 who are at elevated risk for breast cancer by virtue by a hereditary predisposition

You may qualify if:

• Female
• Age 25 years or greater
• Genetic predisposition as defined by one of the following:
• Known BRCA1 or BRCA2 mutation (deleterious or uncertain significance) OR
• Untested first-degree relative of an individual with a known deleterious BRCA mutation OR
• Unaffected first-degree relative of an affected individual within a hereditary breast-ovarian kindred in which no testing has been performed or testing is negative, defined as: 3 or more women in 2 generations affected with breast or ovarian cancer. Women with bilateral breast cancer and woman with both breast and ovarian cancer count as single individual AND 1 woman must be first-degree relative of the other two, or related to the other two through a male AND At least 1 woman affected with breast cancer before age 50 or ovarian cancer at any age
• Able to understand and complete English-language questionnaires
• Intend to receive clinical and radiographic follow-up at MSKCC
• Women will not be excluded if they have previously received clinical and radiographic follow-up at either MSKCC or another institution.

You may not qualify if:

• Prior history of breast or ovarian cancer
• Contraindication to breast MRI examination (e.g. aneurysm clips, pacemaker, cochlear implant, severe claustrophobia, weight over 300 pounds) or to paramagnetic contrast (prior IgE-type allergic reaction, sickle cell anemia, renal failure)
• Pregnant or planning to begin attempts at conception within 1 year of enrollment. A negative serum β-hCG will not be required for study entry, nor for radiographic examination, as this test is not routinely performed before clinically indicated radiographic study.
• Unable for physical, psychological, or financial reasons to receive clinical and radiographic follow-up at MSKCC
• Concurrent medical or psychological conditions that, in the opinion of the attending physician or Principal Investigator, would place the subject at risk were she to participate

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark Robson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: May 1, 2003
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 10, 2009

Record last verified: 2009-07

Locations

US (1)