A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03729115|
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Magnetic Resonance Imaging (MRI) Other: Clinical Hypnosis Other: Anxiety Self-management Techniques||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personalized Risk-based Prevention for Diverse Populations of High Risk Women|
|Actual Study Start Date :||February 18, 2019|
|Estimated Primary Completion Date :||December 20, 2021|
|Estimated Study Completion Date :||December 20, 2023|
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.
- Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model (PRISM) for diverse populations of high risk women. [ Time Frame: 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. [ Time Frame: 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.
- Calculation of total healthcare costs for woman under going biannual (2x per year) screening for breast cancer [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729115
|Contact: Ilona Siljanderfirstname.lastname@example.org|
|United States, Illinois|
|University Of Chicago Medicine Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Ilona Siljander 773-702-2781|
|Principal Investigator: Olufunmilayo Olopade, MD|
|Principal Investigator:||Olufunmilayo I Olopade, MD||University of Chicago|