Clinical trial NCT02256670: Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Hormone Receptor Positive
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 therapy.

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 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.

Eligibility criteria: 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 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 Criteria:

* Patients with ductal carcinoma in situ

Primary outcomes:
measure: Patient Acceptance of Text Message Program
timeFrame: 3 months
measure: Adherence to Endocrine Therapy
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 3 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Sarah Mougalian, MD
role: PRINCIPAL_INVESTIGATOR
References: