Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial

Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:October 2014
End Date:December 2015
Contact:Sarah Mougalian, MD

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Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial: Efficacy of a Text-messaging Application in Increasing Adherence With Adjuvant Endocrine Therapy for Stage I-III Hormone Receptor Positive Breast Cancer

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 therapy.

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 years of adjuvant endocrine therapy with drugs such as tamoxifen or
aromatase inhibitors (AIs). In women with stage I-III breast cancer, treatment with adjuvant
endocrine therapy has been shown to reduce recurrences by 30-50% and improve survival.
Unfortunately, it is estimated from large population databases that up to 35-40% of patients
may discontinue adjuvant endocrine therapy before completing the recommended 5 years for
various reasons, and non-adherence may reduce survival.

The current protocol is a pilot study in women with hormone receptor positive breast cancer
who are beginning adjuvant endocrine therapy, the purpose of which is to assess the
feasibility of a two-way text messaging application, with goals for a larger randomized
control study to assess if the application will increase adherence and therefore improve
disease free survival. This application includes daily text message medication reminders and
periodic assessment of side effects and barriers to medication adherence and simultaneously
offers assistance for treatment related issues. The investigators will collect information
on QOL and financial burden during the 3 month period and will correlate these metrics with
adherence. This larger randomized control study would be the first such interventional study
to increase adherence with adjuvant endocrine therapy in breast cancer in the US. Our larger
randomized control trial would provide the first longitudinal prospectively collected
information on QOL, financial burden and adherence over the entire 5-year treatment period
in the routine clinical practice setting.

Inclusion Criteria:

- 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

- 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 Criteria:

- Patients with ductal carcinoma in situ
We found this trial at
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Phone: 203-785-4022
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
New Haven, CT
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