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A Feasibility Trial of a Web Based App Intervention in Hormone Positive Breast Cancer Patients to Improve Adherence to Endocrine Therapy

NCT05488145 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-17

No results posted yet for this study

Summary

This clinical trial looks at the use of an internet-based application (app) intervention in improving adherence to endocrine therapy (ET) among patients with early stage hormone receptor-positive HER2-negative breast cancer. ET can significantly reduce the return of the cancer in patients who are compliant with their treatment regimen. Despite this, adherence to ET is poor due to side effects, lack of social support and timely access to clinicians, and poor patient understanding of the necessity and effectiveness of the therapy. An internet-based app may help patients improve their adherence to ET by providing reminders, side effect mitigation strategies available in the educational videos and from contacting providers/ nurse on the research team directly via the app.

Conditions

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

Interventions

OTHER

Best Practice

Receive standard of care

OTHER

Internet-Based Intervention

Receive application intervention

OTHER

Questionnaire Administration

PROMIS medication adherence questionnaire is a well-defined self-report measure of medication-taking habits used to objectively assess adherence to medication and therapy. At the end of the study period, we will perform data analysis.

OTHER

Survey Administration

Improvement in patient satisfaction will be measured by utilizing Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey scores. Surveys will be conducted among all participants at baseline and at 12 weeks, regardless of their use of the app, to better understand any barriers to using the app and which aspects of the app were most useful to patients.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Jane L. Meisel, MD · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2025-12-10
Completion
2025-12-10

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 NCT05488145 on ClinicalTrials.gov