Clinical trial NCT02212834: Surveillance Imaging Modalities for Breast Cancer Assessment
Official title: Comparative Effectiveness of Surveillance Modalities in Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast
Cancer
Surveillance
Imaging
Comparative
Effectiveness
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: Harvard Pilgrim Health Care
name: University of North Carolina, Chapel Hill
name: University of California, San Francisco
name: University of Wisconsin, Madison
name: Patient-Centered Outcomes Research Institute
First posted: 2014-08-08
Enrollment: 36444
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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

Detailed 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.

Eligibility criteria: 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.

-

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

Primary outcomes:
measure: Number of Breast Cancers Detected
timeFrame: 12 months post surveillance exam
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Group Health Research Institute
name: Karen J. Wernli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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 Breast Cancer. Radiology. 2019 Aug;292(2):311-318. doi: 10.1148/radiol.2019182475. Epub 2019 Jun 4.