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

• ClinicalTrials.gov Identifier: NCT02057029
• Recruitment Status: Completed
• First Posted: February 6, 2014
• Last Update Posted: January 8, 2016
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Early Stage Estrogen Receptor (ER) Positive Breast Cancer	Behavioral: BCI Assay Results	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 Start Date: January 2014
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm

Intervention/treatment

BCI Assay Results; 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.

Outcome Measures

Primary Outcome Measures :

1. Patient Endocrine Therapy Questionnaires [ Time Frame: 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.
2. Patient Endocrine Therapy Questionnaires [ Time Frame: 4 weeks ]
   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 :

1. State-Trait Anxiety Inventory [ Time Frame: 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.
2. Decision Conflict Scale [ Time Frame: 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.
3. State-Trait Anxiety Inventory [ Time Frame: 4 weeks ]
   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. Decision Conflict Scale [ Time Frame: 4 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Yale University

Investigators

• Principal Investigator: Tara Sanft, MD; Yale University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02057029
• Other Study ID Numbers: HIC#: 1309012695
• First Posted: February 6, 2014
• Last Update Posted: January 8, 2016
• Last Verified: January 2016

Keywords provided by Yale University:

Estrogen Receptor (ER) Positive; Early Stage Breast Cancer; Breast Cancer Index

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases