Clinical trial · Interventional
THRIVE Breast Cancer App Study
Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence
NCT03592771CI-TRIAL-00069308THRIVEcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tailored Feedback Messages | Behavioral | — | UNRESOLVED |
| THRIVE App | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months.
- type
- ACTIVE_COMPARATOR
- label
- THRIVE App
- description
- 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.
- interventionNames
- Behavioral: THRIVE App
- type
- ACTIVE_COMPARATOR
- label
- THRIVE App+Feedback
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (7)
- BACKGROUNDPaladino 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 31856812
- DERIVEDGraetz 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;12(1):33. doi: 10.1038/s41523-026-00900-9. PMID 41605963
- DERIVEDHu 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 41005350
- DERIVEDGraetz 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 40779883
- DERIVEDArshad 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. 2026 Apr;61(2):e14658. doi: 10.1111/1475-6773.14658. Epub 2025 Jun 17. PMID 40525537
- DERIVEDKrukowski 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.