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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057029
• Other study ID #: HIC#: 1309012695
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: January 6, 2016
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Early Stage Estrogen Receptor (ER) Positive Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline	No
Primary	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.	4 weeks	No
Secondary	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.	baseline	No
Secondary	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.	baseline	No
Secondary	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.	4 weeks	No
Secondary	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.	4 weeks	No