Overview

This trial is active, not recruiting.

Condition breast cancer
Sponsor Group Health Cooperative
Collaborator Dartmouth-Hitchcock Medical Center
Start date October 2013
End date September 2016
Trial size 40000 participants
Trial identifier NCT02212834, CE-1304-6656

Summary

SIMBA is a three aim observational study seeking to better understand the comparison of mammography versus MRI for looking for recurrent breast cancer in women with a previous history of breast cancer. There are three components of data collection and analysis:

1. Imaging data from registries participating in the Breast Cancer Surveillance Consortium will be used to compare the outcomes of mammography and MRI in a national cohort of women.

2. Focus groups will be conducted with women with a history of breast cancer at three different sites around the U.S. to learn more about the imaging experience, preference and decision-making in women with a previous history of breast cancer.

3. Informational interviews with physicians who provide breast cancer care will be conducted at three locations around the U.S. to better understand their decision-making process about breast cancer imaging for women with a previous history of breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Women with breast cancer history

Primary Outcomes

Measure
Comparative sensitivity and specificity of mammography and MRI
time frame: This analysis will take up to three years

Secondary Outcomes

Measure
Identification of patient preferences for how primary outcome is depicted for patients to enable them to participate in the imaging decision-making process.
time frame: Three years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: Women included in the Breast Cancer Surveillance Consortium who are 18+ years of age at the the of a Stage 0-III incident breast cancer diagnosis between January 1, 2005 and December 31, 2012. - Exclusion Criteria: - Women with a diagnosis of lobular carcinoma in situ - Women with missing cancer staging data from SEER records - Women with Stage 4 breast cancer at time of diagnosis - Women with a diagnosis of a second breast cancer event within six months of the primary diagnosis - Women who die within six months of primary diagnosis

Additional Information

Official title Comparative Effectiveness of Surveillance Modalities in Breast Cancer Survivors
Principal investigator Karen J. Wernli, PhD
Description The Breast Cancer Surveillance Consortium (BCSC) was established in 1996 with funding from the National Cancer Institute. It currently includes mammography registries from six sites in six U.S. states (Washington, California, Illinois, Vermont, New Hampshire and North Carolina). On a set schedule, these registries send breast cancer screening, diagnostic, treatment and survival data to the BCSC Statistical Coordinating Center (SCC), based at the Group Health Research Institute for analysis. For this project, SCC biostatisticians and programmers will create and analyze the imaging data for the sub-cohort of women in the BCSC with a previous history of Stage 0-III breast cancer Diagnosed between January 1, 2005 and December 31, 2012, in order to examine the first aim listed above.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Group Health Cooperative.