Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message Application
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Hormone Receptor Positive
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
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Text Message Application Intervention
Arm Description
The study intervention will include a mobile phone two-way text message application. Each prompt described below will generate either a yes (Y)/no (N) or ABCDE(F) response from patients. Each response will generate further prompts resulting in either notification for providers to call patients or relevant phone numbers for patients to call for assistance.
Outcomes
Primary Outcome Measures
Patient Acceptance of Text Message Program
Using self-report surveys to assess feasibility and patient acceptance of text message program
Adherence to Endocrine Therapy
Adherence rates after 3 months on study, compared with historical controls. Adherence is defined as taking > 80% of prescribed pills based on self reported adherence questionnaire. This threshold was adopted from the literature. Adherence will also be assessed by checking electronic pharmacy dispensation records when feasible.
Secondary Outcome Measures
Quality of Life
Measure quality of life (QOL) and financial burden and correlate with medication adherence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02256670
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Hormone Receptor Positive
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text Message Application Intervention
Arm Type
Experimental
Arm Description
The study intervention will include a mobile phone two-way text message application. Each prompt described below will generate either a yes (Y)/no (N) or ABCDE(F) response from patients. Each response will generate further prompts resulting in either notification for providers to call patients or relevant phone numbers for patients to call for assistance.
Intervention Type
Behavioral
Intervention Name(s)
Text Message Application
Other Intervention Name(s)
MedAdherence
Intervention Description
Two-way text messaging application addressing adherence with adjuvant endocrine therapy
Primary Outcome Measure Information:
Title
Patient Acceptance of Text Message Program
Description
Using self-report surveys to assess feasibility and patient acceptance of text message program
Time Frame
3 months
Title
Adherence to Endocrine Therapy
Description
Adherence rates after 3 months on study, compared with historical controls. Adherence is defined as taking > 80% of prescribed pills based on self reported adherence questionnaire. This threshold was adopted from the literature. Adherence will also be assessed by checking electronic pharmacy dispensation records when feasible.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Measure quality of life (QOL) and financial burden and correlate with medication adherence
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Mougalian, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial
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