Clinical trial NCT03592771: THRIVE Breast Cancer App Study
Official title: Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: West Cancer Center
name: Vector Oncology
First posted: 2018-07-19
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Adjuvant Endocrine Therapy (AET) Medication Adherence
timeFrame: Up to Month 12
Secondary outcomes:
measure: 19 Item Endocrine Symptom Subscale (ESS-19) Score of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
timeFrame: Baseline, Month 12
measure: Short Form Health Survey (SF-12) Physical Component Summary (PCS) Score
timeFrame: Baseline, Month 12
measure: Short Form Health Survey (SF-12) Mental Component Summary (MCS) Score
timeFrame: Baseline, Month 12
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Score
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Memphis
country: United States
facility: West Cancer Center, Midtown
state: Tennessee
city: Memphis
country: United States
facility: West Cancer Center, East Memphis
state: Tennessee
Study officials:
affiliation: Emory University
name: Ilana Graetz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paladino 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.