Ignite Creation Date:
2024-05-05 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00582803
Status:
COMPLETED
Last Update Posted:
2009-07-10
First Post:
2007-12-21
Brief Title:
Adherence to Intensive Surveillance for Hereditary Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Adherence to Intensive Surveillance for Hereditary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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
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-SHIPmodel 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 individuals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None