This phase II trial studies how well telehealth works in improving adherence to endocrine (anti-estrogen) therapy in patients with estrogen receptor and/or progesterone receptor positive (hormone receptor positive) stage 0-III breast cancer who have underwent surgery. Telehealth is an approach to care that uses digital information and communication tools to manage health and well-being. Patients interact with their health care providers via a video chat on a computer or smart phone. Telehealth may help identify the effects of treatment on patients with breast cancer who have underwent surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04054557.
PRIMARY OBJECTIVES:
I. To evaluate if the utilization of automated patient reported outcomes and follow up Telehealth encounters can improve patient adherence with adjuvant endocrine therapy during the first 12 months of study participation.
II. To evaluate if the utilization of Smart Pill Bottles and follow up Telehealth encounters can improve patient adherence with adjuvant endocrine therapy during the first 12 months of study participation.
SECONDARY OBJECTIVES:
I. To evaluate if the utilization of automated patient reported outcomes and follow up Telehealth encounters can improve quality of life and decrease side effects while taking adjuvant endocrine therapy.
II. To evaluate if the utilization of smart pill bottles and follow up Telehealth encounters can improve quality of life and decrease side effects while taking adjuvant endocrine therapy.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive standard of care office visits approximately every 3 months for one year.
ARM II: 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 endocrine therapy (ET) will have a follow up encounter with a research coordinator.
ARM III: 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.
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorMaysa M. Abu-Khalaf
