Status:
COMPLETED
Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial
Lead Sponsor:
Yale University
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pilot study to assess feasibility and patient acceptance of a text message cell phone application for patients with stage I-III, hormone receptor positive breast cancer who start adjuvant endocrine th...
Detailed Description
Approximately 75% of breast cancers express the estrogen and/or progesterone receptor (hormone receptors). The standard of care for women with hormone receptor positive breast cancer is five to ten ye...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed stage I-III, estrogen and/or progesterone receptor positive, as defined by ASCO-CAP guidelines, invasive breast cancer for whom adjuvant hormonal therapy is indicated following standard NCCN practice guidelines
- Patients may enter the study before or within one month of starting endocrine treatment
- Patients with synchronous bilateral breast cancers are eligible if both tumors are hormone receptor positive
- Patient must be able to provide informed consent and agree to:
- Complete questionnaires according to the pre-specified study design
- Own a personal cell phone, agree to receive text messages on a monthly basis (including any costs), and share their personal cell phone number to receive text message reminder
- sign consent to allow research staff to contact their pharmacies to determine prescription refill dates
Exclusion
- Patients with ductal carcinoma in situ
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02256670
Start Date
October 1 2014
End Date
August 1 2016
Last Update
February 6 2017
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519