THRIVE Breast Cancer App Study
Condition: Breast Neoplasm Female
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      For women with hormone receptor-positive breast cancer, long-term use of adjuvant endocrine
      therapy (AET) significantly reduces the risk of hospitalizations, cancer recurrence and
      mortality, and increases quality of life. Despite the known benefits of AETs, many patients
      are nonadherent due to adverse side effects. Furthermore, lower AET adherence among black
      women may be contributing to the large and growing disparities in mortality outcomes.
      Real-time monitoring of treatment-related adverse symptoms and adherence could result in more
      effective management of symptoms, higher medication adherence, and ultimately lower
      recurrence and mortality. To date, however, only a few interventions have aimed to improve
      AET adherence, even fewer have targeted symptom management as a means to improve adherence,
      and none have found a statistically significant improvement on adherence. This study will
      fill this research gap by testing a web-enabled app designed with the explicit goal of
      improving long-term AET adherence. Patient-reported symptoms will be integrated directly with
      the patient's electronic health record, and concerning reports will trigger an alert to the
      patient's care team in order to improve timely patient-provider communication and care
      outside of clinic visits. In a small pilot trial of the study app, the researchers found that
      participants who had recently initiated a new AET and received weekly reminders to use the
      app reported significantly higher adherence to AETs at 8 weeks compared with a control group
      (91% vs. 68%, p=0.02). The proposed study builds on the success of the pilot by: 1) expanding
      the intervention period to six months in order to capture later-onset adverse symptoms that
      are slower to develop; 2) following participants for one to three years, depending on
      enrollment year, to test longer-term effects of the intervention on medication adherence and
      other outcomes; 3) including a larger sample powered to test multiple levels of the
      intervention; and 4) race-stratifying to test for a differential impact by race. This study
      will randomize 360 participants to one of three arms: 1) an "App" group (n=120) that will
      receive weekly reminders to use the study app; 2) an "App+Feedback" group (n=120) that will
      receive weekly reminders and personalized feedback based on their use of the app; or 3) a
      "Usual Care" group (n=120) that will receive usual care only. The app will include questions
      about AET adherence and adverse symptoms with built-in alerts sent to the patient's care team
      if any concerning symptoms or trends are reported. The researchers hypothesize that
      monitoring symptoms and adherence with actionable alerts and tailored feedback reports to
      patients will result in timelier symptom management and higher long-term adherence to AET. By
      evaluating the impact of the intervention on a comprehensive set of measures, including AET
      adherence, patient outcomes, racial disparities and resource use-related costs, this study
      will provide valuable and actionable results for providers, policy makers, and insurers who
      strive to achieve the "Triple Aim" - reduce costs while improving health outcomes and the
      patient experience.
    

Intervention name(s): THRIVE App; Tailored Feedback Messages
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care