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Mobile Health for Adherence in Breast Cancer Patients

NCT06112613 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2026-05-15

No results posted yet for this study

Summary

This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Breast Carcinoma
  • HER2-Negative Breast Carcinoma
  • Hormone Receptor-Positive Breast Carcinoma

Interventions

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Health Promotion and Education

Receive access to educational materials

PROCEDURE

Health Telemonitoring

Utilize the WiseBag medication dispenser

OTHER

Interview

Complete an interview

BEHAVIORAL

Patient Navigation

Receive healthcare provider follow ups as part of the CONCURxP program

OTHER

Survey Administration

Ancillary studies

OTHER

Text Message-Based Navigation Intervention

Receive personalized text message reminders related to their medication tracking as part of the CONCURxP program

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • ECOG-ACRIN Cancer Research Group

    lead NETWORK

Principal Investigators

  • Gelareh Sadigh · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-26
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United States
  • Puerto Rico

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 NCT06112613 on ClinicalTrials.gov