CAPS: A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
Study Details
Study Description
Brief Summary
This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Screening Arm Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram. |
Procedure: Magnetic Resonance Imaging (MRI)
Patients will have MRI scans every 6 months.
Other: Clinical Hypnosis
Patients will provided with an audio recording which includes the technique of Clinical Hypnosis to help manage anxiety during MRI scans.
Other: Anxiety Self-management Techniques
Participants will be given a workbook with tools and techniques to help manage anxiety and stress related to getting the MRI scans and their overall healthcare.
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Outcome Measures
Primary Outcome Measures
- Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women. [5 years]
We will test whether an abbreviated MRI (AB-MRI) is diagnostically equivalent to a full MRI. Eligible women will be scanned every 6 months with a full protocol MRI.
- Anxiety-reduction in high risk women undergoing MRI using a combination of cognitive-behavioral techniques and clinical hypnosis. [5 years]
The cognitive-behavioral anxiety management techniques will be presented in a workbook format and the clinical hypnosis will be presented as an audio recording. Patients will self report their level of anxiety before, during and after MRI.
Secondary Outcome Measures
- Calculation of total healthcare costs for woman under going biannual (2x per year) screening for breast cancer [5 years]
Total calculated costs for semi-annual Dynamic Contrast-Enhanced (DCE) MRI screening exams and downstream tests, including diagnostic mammograms, short interval MRI follow-up exams, breast ultrasounds, and breast biopsies will be calculated.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Known BRCA1 or BRCA2, TP53, PALB2, PTEN and CDH1 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high Polygenic Risk Score.
OR With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors.
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Without prior breast cancer.
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Must be older than 25 years.
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Willing to travel to University of Chicago Medical Center for imaging studies as well as any necessary follow-up procedures.
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Be able to give informed consent.
Exclusion Criteria
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Active cancer at the time of enrollment.
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Current pregnancy or plans for pregnancy within two years of enrollment.
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Presence of a pacemaker or any other metallic foreign objects in their body that interferes with an MRI.
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Breast surgery within two weeks of study entry.
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History of kidney disease or abnormal kidney function.
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Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors or participating in a chemoprevention trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Of Chicago Medicine Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
Sponsors and Collaborators
- University of Chicago
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Olufunmilayo I Olopade, MD, University of Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB18-0970