Trial Summary
What is the purpose of this trial?This trial uses video chats, online surveys, and special pill bottles to help breast cancer patients stick to their medication. It targets patients who have had surgery for hormone receptor-positive breast cancer. The tools remind patients to take their medication and provide easy ways to report side effects and get help. Tamoxifen, aromatase inhibitors, and fulvestrant have been used for decades in the therapy of hormone-receptor-positive breast cancer patients.
Eligibility Criteria
This trial is for men and women with stage 0-III hormone receptor positive breast cancer who've had surgery. Participants need a cell phone, must be able to text, have an ECOG status of 0-2, and agree to use telehealth tools like video chat. They should not have metastatic breast cancer or be unable to use digital communication tools.Treatment Details
The study tests if telehealth improves adherence to anti-estrogen therapy after surgery in breast cancer patients. It includes best practices, behavioral and educational interventions, questionnaires on quality-of-life, surveys, and uses smart pill bottles for medication tracking.
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (Smart Pill Bottle, messaging)Experimental Treatment4 Interventions
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.
Group II: Arm II (Standard of Care Office Visits, survey, telehealth)Experimental Treatment5 Interventions
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.
Group III: Arm I (Standard of Care office Visits)Active Control3 Interventions
Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Jefferson Health - Asplundh Cancer PavilionWillow Grove, PA
Methodist HospitalPhiladelphia, PA
Jefferson Health - South JerseyWashington Township, NJ
Thomas Jefefrson UniversityPhiladelphia, PA
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor