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.
