Surveillance Imaging Modalities for Breast Cancer Assessment

Breast Cancer Clinical Trial

— SIMBA  

Official title:

Comparative Effectiveness of Surveillance Modalities in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212834
• Other study ID #: CE-1304-6656
• Status: Completed
• Start date: October 2013
• Est. completion date: November 2016

Study information

• Verified date: September 2021
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of surveillance breast MRI compared to mammography alone in women with a personal history of breast cancer

Description:

Our overall aim is to find out how well MRI works compared with mammography for surveillance in women who have previously had breast cancer. Specifically, our goals are to:

1. Understand doctors' and patients' experiences with surveillance mammography and MRI

2. Provide evidence on which outcomes are more or less likely to occur

3. Develop patient decision aids to help women and their doctors choose the surveillance method that is right for them

How we will conduct the study: We will work with patients, doctors, policy makers, advocacy groups, and researchers to improve surveillance for women who have a personal history of breast cancer. Through focus groups with patients and interviews with doctors, we will gain insights into women's experience with surveillance mammography and MRI. We will also compare mammography to MRI using data from the Breast Cancer Surveillance Consortium-the largest collection of breast cancer surveillance data in the nation. We will use data from more than 13,000 women diagnosed with breast cancer between 2005 and 2012 to determine how well each test works. We will measure the tests' effectiveness at finding second cancers, and estimate the likelihood of different outcomes. We will also determine whether one test appears to work better than the other to detect second breast cancers among different groups of women. We will then develop patient decision aids to help women and their doctors make more-informed choices about surveillance.

What we hope to achieve: We hope this study will improve medical decision making and care for the 3 million women in the United States who have a history of breast cancer. Specifically, our results will help women and their doctors make clearer, better choices about the surveillance method that is right for them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36444
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Surveillance imaging exams in 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.

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Exclusion Criteria:

• Women with a diagnosis of lobular carcinoma in situ

• Women with missing cancer staging data from Surveillance, Epidemiology and End Results (SEER) Program 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

• Women who have had a double mastectomy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Kaiser Permanente	Dartmouth College, Harvard Pilgrim Health Care, Patient-Centered Outcomes Research Institute, University of California, San Francisco, University of North Carolina, Chapel Hill, University of Wisconsin, Madison

References & Publications (3)

Henderson LM, Ichikawa L, Buist DSM, Lee JM, Bush M, Johnson D, Onega T, Nekhlyudov L, Kerlikowske K, Miglioretti DL, Sprague BL, Wernli KJ. Patterns of Breast Imaging Use Among Women with a Personal History of Breast Cancer. J Gen Intern Med. 2019 Oct;34(10):2098-2106. doi: 10.1007/s11606-019-05181-6. Epub 2019 Aug 13. — View Citation

Johnson DS, Bush MT, Brandzel S, Wernli KJ. The patient voice in research-evolution of a role. Res Involv Engagem. 2016 Feb 22;2:6. doi: 10.1186/s40900-016-0020-4. eCollection 2016. — View Citation

Wernli KJ, Ichikawa L, Kerlikowske K, Buist DSM, Brandzel SD, Bush M, Johnson D, Henderson LM, Nekhlyudov L, Onega T, Sprague BL, Lee JM, Lehman CD, Miglioretti DL. Surveillance Breast MRI and Mammography: Comparison in Women with a Personal History of Br — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Breast Cancers Detected	Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI	12 months post surveillance exam

External Links

•   SIMBA Decision tool
•   Video of impact of patient engagement in research