Adherence to Intensive Surveillance for Hereditary Breast Cancer

Breast Cancer Clinical Trial

Official title: Adherence to Intensive Surveillance for Hereditary Breast Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00582803
• Study type: Observational
• Source: Memorial Sloan Kettering Cancer Center
• Status: Completed
• Phase: N/A
• Start date: May 2003
• Completion date: March 2009