Breast Cancer, Early Stage Estrogen Receptor (ER) Positive Breast Cancer
Conditions
Keywords
Estrogen Receptor (ER) Positive, Early Stage Breast Cancer, Breast Cancer Index
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBCI 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.
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Each patient must meet all of the following criteria in order to be considered for enrollment: * Histologically confirmed ER positive, stage I-III breast cancer who have been treated with curative intent and completed at least four years of adjuvant endocrine therapy. * Life expectancy ≥ 5 years. * Must be able to provide informed consent. * Willing to consider continuation of endocrine therapy beyond 5 years.
Exclusion criteria
* A patient must not be enrolled if any contraindication exists for extended adjuvant endocrine therapy as identified by the treating oncologist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Endocrine Therapy Questionnaires | baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory | baseline | 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. |
| Decision Conflict Scale | baseline | 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. |
Countries
United States
Outcome results
None listed