Back to resultsAssessment 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
Primary Purpose
Breast Cancer, Early Stage Estrogen Receptor (ER) Positive Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BCI Assay Results
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Estrogen Receptor (ER) Positive, Early Stage Breast Cancer, Breast Cancer Index
Eligibility Criteria
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.
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
BCI Assay Results
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02057029
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Early Stage Estrogen Receptor (ER) Positive Breast Cancer
Keywords
Estrogen Receptor (ER) Positive, Early Stage Breast Cancer, Breast Cancer Index
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BCI Assay Results
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BCI Assay Results
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Endocrine Therapy Questionnaires
Description
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
Title
Patient Endocrine Therapy Questionnaires
Description
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
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory
Description
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
Title
Decision Conflict Scale
Description
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
Title
State-Trait Anxiety Inventory
Description
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
Title
Decision Conflict Scale
Description
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Sanft, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26578401
Citation
Sanft T, Aktas B, Schroeder B, Bossuyt V, DiGiovanna M, Abu-Khalaf M, Chung G, Silber A, Hofstatter E, Mougalian S, Epstein L, Hatzis C, Schnabel C, Pusztai L. Prospective 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 Res Treat. 2015 Dec;154(3):533-41. doi: 10.1007/s10549-015-3631-9. Epub 2015 Nov 14.
Results Reference
derived
Learn more about this trial
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
We'll reach out to this number within 24 hrs