THRIVE Breast Cancer App Study

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. Our proposed 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, we 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 our 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. We 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. We 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, our 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.

Inclusion Criteria:

1. Adult female patients (age≥18)

2. Diagnosis of ductal carcinomain situ or Stage I-III hormone receptor-positive breast
cancer

3. New prescription for an aromatase inhibitor or tamoxifen

4. Have a mobile device with a data plan or a home computer with Internet

5. Have a valid email address

6. Willing to complete brief surveys on a web-enabled device

Exclusion Criteria:

1. Unable to communicate in English

2. Prior use of adjuvant endocrine therapy (aromatase inhibitor or tamoxifen) for current
diagnosis

3. Concurrently undergoing surgery, chemotherapy or radiation

4. Current diagnosis of rheumatoid arthritis

5. Current diagnosis of fibromyalgia

5. Chronic daily narcotic usage