An interventional study of BCI Assay Results in Breast Cancer and Early Stage Estrogen Receptor (ER) Positive Breast Cancer, sponsored by Yale University. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2016-01-08.
Sponsored by Yale University · Not applicable, Interventional, and Diagnostic
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.
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This study's enrollment of 96 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Each patient must meet all of the following criteria in order to be considered for enrollment:
Exclusion Criteria:
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.
Behavioral: BCI Assay 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.
Patient Endocrine Therapy Questionnaires
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.
Time frame: baseline
Patient Endocrine Therapy Questionnaires
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.
Time frame: 4 weeks
State-Trait Anxiety Inventory
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.
Time frame: baseline
Decision Conflict Scale
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.
Time frame: baseline
State-Trait Anxiety Inventory
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.
Time frame: 4 weeks
Decision Conflict Scale
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.
Time frame: 4 weeks
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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