Patient Reported Outcomes, Smart Pill Bottle and Teleheath for Endocrine Therapy Adherence
NCT04054557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 305
Last updated 2026-02-05
Summary
This phase II trial studies how well telehealth works in improving adherence to endocrine (anti-estrogen) therapy in participants 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. Participants 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 participants with breast cancer who have underwent surgery.
Conditions
- Stage 0 Breast Cancer AJCC v6 and v7
- Stage I Breast Cancer AJCC v7
- Stage IA Breast Cancer AJCC v7
- Stage IB Breast Cancer AJCC v7
- Stage II Breast Cancer AJCC v6 and v7
- Stage IIA Breast Cancer AJCC v6 and v7
- Stage IIB Breast Cancer AJCC v6 and v7
- Stage IIIA Breast Cancer AJCC v7
- Stage IIIB Breast Cancer AJCC v7
- Stage IIIC Breast Cancer AJCC v7
- Stage III Breast Cancer AJCC v7
Interventions
- OTHER
-
Telemedicine
Participate in virtual visits with oncologist
- OTHER
-
Best Practice
Receive 4 in-office visits with oncologist
- OTHER
-
Questionnaire Administration
Ancillary studies
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Survey Administration
Complete electronic survey
- BEHAVIORAL
-
Behavioral Intervention
Use smart pill bottle
- OTHER
-
Educational Intervention
Receives time-specific reminders and messages
Sponsors & Collaborators
-
Thomas Jefferson University
lead OTHER
Principal Investigators
-
Maysa Abu-Khaaf, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-31
- Primary Completion
- 2024-12-06
- Completion
- 2024-12-06
Countries
- United States
Study Locations
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