NCT03592771

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 5, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

3.6 years

First QC Date

July 5, 2018

Results QC Date

June 29, 2023

Last Update Submit

August 11, 2023

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

  • Adjuvant Endocrine Therapy (AET) Medication Adherence

    Medication adherence with prescribed AET (aromatase inhibitor or tamoxifen) is captured using an electronic monitoring pillbox (Wisepill).

    Up to Month 12

Secondary Outcomes (4)

  • 19 Item Endocrine Symptom Subscale (ESS-19) Score of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

    Baseline, Month 12

  • Short Form Health Survey (SF-12) Physical Component Summary (PCS) Score

    Baseline, Month 12

  • Short Form Health Survey (SF-12) Mental Component Summary (MCS) Score

    Baseline, Month 12

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Score

    Baseline, Month 12

Study Arms (3)

Usual Care

NO INTERVENTION

Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months.

THRIVE App

ACTIVE COMPARATOR

Participants use a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants receive reminders via text or email to use the app once per week during the 6-month intervention phase. Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months.

Behavioral: THRIVE App

THRIVE App+Feedback

ACTIVE COMPARATOR

Participants use a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants receive reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group will also receive weekly tailored feedback text messages or images during the 6-month intervention phase. Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months.

Behavioral: THRIVE AppBehavioral: Tailored Feedback Messages

Interventions

THRIVE AppBEHAVIORAL

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.

THRIVE AppTHRIVE App+Feedback
Tailored Feedback MessagesBEHAVIORAL

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.

THRIVE App+Feedback

Eligibility Criteria

Age18 Years - 110 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult female patients (age≥18)
  • Diagnosis of ductal carcinoma in situ or Stage I-III hormone receptor-positive breast cancer
  • New prescription for an aromatase inhibitor or tamoxifen
  • Have a mobile device with a data plan or a home computer with Internet
  • Have a valid email address
  • Willing to complete brief surveys on a web-enabled device
  • AET is indicated as standard of care

You may not qualify if:

  • Unable to communicate in English
  • Prior use of adjuvant endocrine therapy (aromatase inhibitor or tamoxifen) for current diagnosis
  • Concurrently undergoing surgery, chemotherapy or radiation
  • Current diagnosis of rheumatoid arthritis
  • Chronic daily narcotic usage
  • Patient plans to move or transfer their care within the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West Cancer Center, Midtown

Memphis, Tennessee, 38104, United States

Location

West Cancer Center, East Memphis

Memphis, Tennessee, 38138, United States

Location

Related Publications (7)

  • Paladino AJ, Anderson JN, Krukowski RA, Waters T, Kocak M, Graff C, Blue R, Jones TN, Buzaglo J, Vidal G, Schwartzberg L, Graetz I. THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer. BMC Health Serv Res. 2019 Dec 19;19(1):977. doi: 10.1186/s12913-019-4588-x.

    PMID: 31856812BACKGROUND

  • Graetz I, Hu X, Krukowski RA, Anderson JN, Stepanski E, Vidal G, Waters TM, Schwartzberg LS. Adherence to oral endocrine therapy by menopausal status: post hoc insights from a remote monitoring randomized trial. NPJ Breast Cancer. 2026 Jan 28. doi: 10.1038/s41523-026-00900-9. Online ahead of print.

    PMID: 41605963DERIVED

  • Hu X, Krukowski RA, Stepanski E, Anderson JN, Vidal GA, Torres MA, Schwartzberg LS, Graetz I. Racial Differences in Symptom Burden and Endocrine Therapy Adherence in Breast Cancer: A Post Hoc Analysis of a Randomized Trial. J Natl Compr Canc Netw. 2025 Sep 26;23(10):e257054. doi: 10.6004/jnccn.2025.7054.

    PMID: 41005350DERIVED

  • Graetz I, Hernandez S, Hu X, Krukowski RA, Anderson JN, Waters TM, Stepanski E, Vidal GA, Schwartzberg LS. Addressing health literacy gaps in adjuvant endocrine therapy adherence: Post hoc insights from a randomized remote monitoring trial. Breast. 2025 Oct;83:104552. doi: 10.1016/j.breast.2025.104552. Epub 2025 Aug 5.

    PMID: 40779883DERIVED

  • Arshad S, Hu X, Krukowski RA, Waters TM, Vidal GA, Schwartzberg L, Lipscomb J, Graetz I. COVID-19-Related Financial Hardship and Adherence to Adjuvant Endocrine Therapy Among Women With Early-Stage Breast Cancer. Health Serv Res. 2025 Jun 17:e14658. doi: 10.1111/1475-6773.14658. Online ahead of print.

    PMID: 40525537DERIVED

  • Krukowski RA, Hu X, Arshad S, Anderson JN, Stepanski E, Vidal GA, Schwartzberg LS, Graetz I. Symptom Monitoring App Use Associated With Medication Adherence Among Woman Survivors of Breast Cancer on Adjuvant Endocrine Therapy. JCO Clin Cancer Inform. 2024 Dec;8:e2400179. doi: 10.1200/CCI-24-00179. Epub 2024 Dec 6.

    PMID: 39642329DERIVED

  • Graetz I, Hu X, Kocak M, Krukowski RA, Anderson JN, Waters TM, Curry AN, Robles A, Paladino A, Stepanski E, Vidal GA, Schwartzberg LS. Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417873. doi: 10.1001/jamanetworkopen.2024.17873.

    PMID: 38935379DERIVED

Results Point of Contact

Title
Ilana Graetz, PhD
Organization
Emory University
ilana.graetz@emory.edu
404-727-1483

Study Officials

  • Ilana Graetz, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 19, 2018

Study Start

November 15, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 5, 2023

Results First Posted

September 5, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)