Adherence to Intensive Surveillance for Hereditary Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00582803
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : July 10, 2009
American Cancer Society, Inc.
Information provided by:
Memorial Sloan Kettering Cancer Center

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.

Condition or disease
Breast Cancer

Detailed Description:
Women at risk for hereditary breast cancer are recommended to undergo intensive surveillance to maximize the likelihood of detecting the disease at an early, more curable, stage (Burke et al. 1997, Eisenger et al. 1998, Moller et al. 1999). Although the particular recommendations of different groups have varied, all suggest programs that incorporate clinical and radiographic screening performed more frequently than in the general population, beginning at a considerably younger age. Recent studies demonstrating the sensitivity of breast MRI have led several groups to incorporate this technology as an incremental (not replacement) modality, further increasing the intensity of the surveillance regimen. While data are beginning to accumulate regarding the effectiveness of aggressive surveillance, little is known about the ability and willingness of women to adhere to these rigorous schedules, nor about the psychosocial and economic costs of the programs. Based upon the Cognitive-Social Health Information Processing (C-SHIP)model (Miller, Shoda, Hurley 1996), we hypothesize that the ability to adhere to a proposed screening regimen will result from a complex and dynamic interaction between the nature of that regimen, events that can be expected to occur in the course of screening (such as abnormal results and practical barriers) and key psychological factors such as the individual's attentional style, affective state, perceived risk of cancer, cancer-specific worries, and beliefs regarding the effectiveness of screening. To test the hypothesis, we propose to prospectively study women with a hereditary risk for breast cancer participating in a structured surveillance program of monthly breast self-examination, semi-annual clinical examination and annual mammography, augmented by annual interval breast MRI.

Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adherence to Intensive Surveillance for Hereditary Breast Cancer
Study Start Date : May 2003
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. cognitive-affective mediating units that are likely to be involved in health information processing and the execution of health-protective behavior [ Time Frame: 5 years 7 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00582803

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
American Cancer Society, Inc.
Principal Investigator: Mark Robson, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Mark Robson, MD, Memorial Sloan-Kettering Cancer Center Identifier: NCT00582803     History of Changes
Other Study ID Numbers: 03-059
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009

Keywords provided by Memorial Sloan Kettering Cancer Center:
breast cancer
germline mutation
family history
genetic testing
unaffected women over age 25 who are at elevated risk for
breast cancer by virtue by a hereditary predisposition

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases