Clinical trial NCT02057029: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Early Stage Estrogen Receptor (ER) Positive Breast Cancer
Keywords: Estrogen Receptor (ER) Positive
Early Stage Breast Cancer
Breast Cancer Index
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 96
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Patient Endocrine Therapy Questionnaires
timeFrame: baseline
measure: Patient Endocrine Therapy Questionnaires
timeFrame: 4 weeks
Secondary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: baseline
measure: Decision Conflict Scale
timeFrame: baseline
measure: State-Trait Anxiety Inventory
timeFrame: 4 weeks
measure: Decision Conflict Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Tara Sanft, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.