Clinical Trials Logo
NCT number NCT03180086
Study type Interventional
Source Beth Israel Deaconess Medical Center
Contact Mara Schonberg, MD, MPH
Phone 617-754-1414
Email mschonbe@bidmc.harvard.edu
Status Recruiting
Phase N/A
Start date July 1, 2017
Completion date July 1, 2021

Clinical Trial Summary

In a randomized controlled trial, the investigators will test the effect of a novel strategy for breast cancer risk assessment and risk-based management of women in their 40s seen in primary care. The investigators anticipate that this approach will lead to more optimal use of mammography screening and breast cancer prevention interventions in women in their 40s and as a result will improve care of these women.


Clinical Trial Description

There is currently no standardized practice for addressing breast cancer risk in primary care. While there are guidelines encouraging PCPs to assess patients' breast cancer risk, few PCPs assess patients' risk due to time constraints in primary care, lack of familiarity with risk calculators, and knowledge on how to incorporate risk into the care of women. Around 20% of PCPs have reported using a risk calculator but few routinely asses patients' risk. In HealthCare Associates (HCA), Beth Israel Deaconess Medical Center's primary-care based practice, the online medical record (OMR) has recently been edited to allow for PCPs to enter patients' breast cancer risk. However, it is not known whether PCPs are using this tab. To calculate patient's breast cancer risk, PCPs must go to web-based calculators, ask patients their risk factors, enter the information and then add the estimated risk to OMR. Previous studies suggest that leaving risk assessment to PCPs results in few women having their risk assessed. Instead, PCPs tend to simply use family history when deciding whether or not patients are at high risk. However, family history is only one risk factor for breast cancer. Therefore, the investigators will send women ages 40-49 participating in this study a questionnaire to complete before a visit to assess their risk factors for breast cancer. Using this information, the investigators will calculate patients' breast cancer risk using the available breast cancer risk assessment models and will present women with a personalized breast cancer risk report immediately before a visit with their PCP. After the visit, patients will be asked to complete a follow-up questionnaire about their experience and through their medical records will be followed to learn whether or not they are screened with mammography. The investigators will follow high-risk women to learn whether or not they receive a screening breast MRI, BRCA gene testing, and/or the option to take breast cancer prevention medications. The investigators aim to recruit 445 women 40-49 years seen at HCA into a single arm trial to learn the effect of our personalized risk based approach to breast cancer screening and prevention on women in their 40's intentions to be screened and knowledge of the pros and cons of screening.

Specific Aims: To determine the effect of a personalized risk based approach for breast cancer screening and prevention for women in their 40s seen in primary care on:

1. women's intentions to be screened with mammography (primary outcome),

2. knowledge of the pros and cons of mammography screening, and

3. decisional conflict around screening; and on

4. patient report of PCP discussion of their breast cancer risk and of the pros and cons of mammography screening.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03095352 - A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease Phase 2
Recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults N/A
Recruiting NCT03284957 - Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer Phase 1/Phase 2
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
Recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
Active, not recruiting NCT02139358 - Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy N/A
Not yet recruiting NCT03289039 - Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer Phase 2
Not yet recruiting NCT03252431 - Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy Phase 3
Recruiting NCT01992432 - Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC) N/A
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Active, not recruiting NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan. N/A
Not yet recruiting NCT03273348 - Role of Oncoplastic Breast Surgery In Breast Cancer Treatement N/A
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Recruiting NCT03237572 - Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer Phase 1
Recruiting NCT02125019 - Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer N/A
Recruiting NCT02739425 - The Efficacy of Sentimag in Detection of Sentinel Node Biopsy N/A
Recruiting NCT02955394 - Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer Phase 2
Recruiting NCT02911155 - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists N/A
Not yet recruiting NCT03271476 - EMDR Psychotherapy to Treat Anxious-depressive Symptoms in Breast Cancer Patient N/A