Patient Reported Outcomes, Smart Pill Bottle and Teleheath for Endocrine Therapy Adherence
Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
About this trial
This is an interventional treatment trial for Stage 0 Breast Cancer AJCC v6 and v7
Eligibility Criteria
Inclusion Criteria:
• Signed informed consent obtained prior to any study specific assessments and procedures
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Women or men diagnosed with stage 0-III hormone receptor positive (estrogen receptor positive [ER] and /or progesterone receptor [PR] positive) breast cancer
* Staging for eligibility should utilize the most recent American Joint Committee on Cancer (AJCC) breast cancer staging version
- Patients (Pts) must have undergone breast surgery for their diagnosis of breast cancer
Adjuvant endocrine therapy has been prescribed by their treating physician
* Patients may receive concurrent adjuvant radiation therapy plus endocrine therapy in the post-operative setting
- Have a cell phone with text messaging ability
- Have access to a computer, tablet, or smart phone to complete electronic surveys
- Patient must be willing to setup an online Jefferson MyChart account
- Patients who have been on endocrine therapy for more than 4 years
Exclusion Criteria:
- Pts with stage IV metastatic breast cancer
- Patients unable to participate in patient portal communication (e.g. do not have either a smart phone, laptop, access to a computer and/ or access to a device with a webcam)
- Pts who are non-English speaking and English illiterate
Sites / Locations
- Jefferson Health - South JerseyRecruiting
- Thomas Jefefrson UniversityRecruiting
- Methodist Hospital
- Jefferson Health - NortheastRecruiting
- Jefferson Health - Asplundh Cancer PavilionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm I (Standard of Care office Visits)
Arm II (Standard of Care Office Visits, survey, telehealth)
Arm III (Smart Pill Bottle, messaging)
Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
Patients receive standard of care as in Arm I and 4 automated electronic surveys every 3 weeks (+/- 1 weeks) for a total of 18 electronic surveys over one year. Patients who report severe or very severe side effects, or stopping or are thinking about stopping their ET will have a follow up encounter with a research coordinator.
Patients receive a wireless smart pill bottle that performs daily time-specific reminders to open the pill bottle and take the medication. Additional messages are triggered by the pill bottle when non-adherence is indicated (lack of bottle opening or no change in remaining pills), as well as when medication is skipped.