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The Breast Cancer Index (BCI) is a novel gene expression-based prognostic predictor for ER positive cancers and is provided through a CLIA certified commercial laboratory. It is an RT-PCR assay that can be performed on formalin fixed paraffin embedded sections of archived tissues. Participants will work in concert with a physician to determine future treatment options based on BCI results.

The nature of the intervention is to utilize the BCI results in the decision making process for ER-positive breast cancer patients and their physicians.

BCI Assay Results

Tara Sanft, MD

Investigators will examine the impact of the Breast Cancer Index (BCI) result on patients' anxiety / fear of recurrence and satisfaction with decisions regarding endocrine therapy.

The investigators' objective is to assess patient decision-making, anxiety and patient satisfaction with recommendations made by an oncologist before and after the BCI test results are known. In addition, a chart review will be performed annually for five years to assess disease status and medications. Specifically, if extended endocrine therapy was recommended the chart review will record if participants are taking the medication and, if not, why the treatment was discontinued.

Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer

These questionnaires are aimed at gathering the patient's perceived risk of recurrence, preference for continuing endocrine therapy after 5 years, concerns surrounding taking additional medication including concerns of cost, side effects, safety and benefit, as well as the level of comfort with the choice made both before and after the BCI test results are known.

Anxiety will be measured using the 20-item State-Trait Anxiety Index. This test differentiates between transient anxiety ('state anxiety') and more long-standing anxiety ('trait anxiety'). Participants will be asked to complete only the state anxiety (STAI-Y1) as trait anxiety is not expected to be modifiable based on the knowledge of the BCI results.

The Decisional Conflict Scale (DCS) will be used to measure the uncertainty of the patient in making a health-related decision (in this case, making the decision to take or not to take extended endocrine therapy), the factors contributing to the uncertainty and the perceived effective decision making.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer	NCT02057029	Breast Cancer Early Stage Est...	BCI Assay Resul...	-	Yale University
Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer	NCT02057029	Breast Cancer Early Stage Est...	BCI Assay Resul...	-	Yale University

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