N/A
N=304
THRIVE Breast Cancer App Study
Breast Neoplasm Female
Bottom Line
View on ClinicalTrials.gov: NCT03592771 ↗Enrolled (actual)
304
Serious AEs
9.9%
Results posted
Sep 2023
Primary outcome: Primary: Adjuvant Endocrine Therapy (AET) Medication Adherence — 77; 73; 71 percentage of prescribed doses taken
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- THRIVE App (Behavioral); Tailored Feedback Messages (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjuvant Endocrine Therapy (AET) Medication Adherence |
77; 73; 71 | — |
| SECONDARY 19 Item Endocrine Symptom Subscale (ESS-19) Score of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) |
62.95; 63.01; 63.47; 60.14; 59.29; 60.54 | — |
| SECONDARY Short Form Health Survey (SF-12) Physical Component Summary (PCS) Score |
44.30; 44.87; 43.99; 44.69; 47.57; 45.25 | — |
| SECONDARY Short Form Health Survey (SF-12) Mental Component Summary (MCS) Score |
50.66; 50.76; 50.68; 51.77; 49.98; 51.95 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Score |
17.28; 16.69; 16.88; 17.39; 16.46; 16.78 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03592771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.