The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die

Breast Fibroadenoma

The Echopulse device is a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast).

High Intensity Focused Ultrasound

University of Virginia Health System

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): A Feasibility Study

Fibroadenoma volume with be measured by ultrasound.

Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.

Patient-rated pain and patient responses to Satisfaction Questionnaire will be measured at intervals up to 12 months following HIFU treatment session

David R. Brenin, MD

Associate Professor, Department of Surgery

Theraclion SAS, Paris, France

This study will be utilizing electronic health record data to identify patients that match the TRIP eligibility criteria and received patient navigation prior to study rollout in June 2018. These patients will receive standard patient navigation at their care site and will act as historical controls in comparison to the TRIP experimental group.

This study will be enhancing current patient navigation at the participating 6 hospitals with the 3 components of the TRIP intervention (a shared patient registry, a social determinants of health platform, and additional training and support for Patient Navigators). All patients that are identified as TRIP eligible will receive these intervention benefits and will be categorized into the experimental arm of the study.

Cancer, Breast

All women with breast cancer diagnosed at a participating study site during the study period will be eligible for inclusion if they meet three study criteria

The TRIP intervention will replace the current standard of care at the 6 participating hospitals once it is rolled out on-site. Any TRIP eligible patients receiving patient navigation services over the course of the study will receive the enhanced services.

TRIP Patient Navigation Intervention

Tufts Medical Center

Massachusetts General Hospital

Boston Medical Center

Beth Israel Deaconess Medical Center

Brigham and Women's Faulkner Hospital

Dana-Farber Cancer Institute

Translating Research Into Practice

Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care

The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality. The time element will be calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable will depend on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation, including but not limited to stage at diagnosis and co-morbid medical conditions.

Boston University

University of Massachusetts, Worcester

Brigham and Women's Hospital

A randomized cluster stepped wedge design will be conducted. This pragmatic design involves a sequential, randomized roll-out of the intervention across 6 participating clinical sites or "clusters" over 3 month intervals or "steps". Consistent with a stepped wedge design with one cluster per step, prior to the collection of data in the pre-intervention period, the investigators will generate a set of uniform random numbers for each of the six clusters to assign a starting period for the study intervention. There will be no crossover of patients from usual care to the intervention. That is, patients at each site during the pre-intervention period will experience only usual care and will act as historical controls and those enrolled after the initiation of intervention will experience the intervention.

lemon/kanceri i gjirit

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

Translating Research Into Practice

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