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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054557 on ClinicalTrials.gov