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THRIVE Breast Cancer App Study

NCT03592771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2023-09-05

Study results available
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Summary

This study will test the use of a web-enabled app that is integrated directly with patients' electronic health records, with and without tailored feedback. The app-based intervention is designed to improve patient-provider communication outside of clinic visits, resulting in improved symptom management and adjuvant endocrine therapy adherence among diverse patients with hormone receptor-positive breast cancer. The researchers will evaluate the impact of the intervention on a comprehensive set of outcomes, including rigorous measures of long-term adherence, quality of life, and costs.

Conditions

  • Breast Neoplasm Female

Interventions

BEHAVIORAL

THRIVE App

Participants in the THRIVE App group receive a weekly text message to prompt them to log into the THRIVE app to answer questions about their AET adherence and related adverse symptoms. The app can be accessed through any web-enabled device or Internet browser. All participant-reported data will be automatically entered into the patient's electronic health record and easily available to the care team for review. Any concerning symptoms or changes will trigger an email alert to the patient's oncology team.

BEHAVIORAL

Tailored Feedback Messages

Participants receive weekly tailored feedback messages and/or images based on their baseline survey responses and use of the app during the 6-month intervention phase. Some tailored feedback includes links to symptom-specific educational materials and coping strategies for participants who report low-severity symptoms. Message categories are tailored to participant's responses to the app and baseline survey.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • West Cancer Center

    collaborator OTHER

  • Vector Oncology

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Ilana Graetz, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2022-06-30
Completion
2022-06-30

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 NCT03592771 on ClinicalTrials.gov