Web-Base App To Improve Aromatase Inhibitor Adherence



Status:Completed
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/21/2018
Start Date:December 2015
End Date:July 2016

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Use of an Innovative Mobile Health Application to Improve Health Outcomes for Breast Cancer Patients

The purpose of this study will be to test the use of a web-based mobile application (app)
initiated at the time of the initial prescription to an aromatase inhibitor to improve
communication and management of treatment-related adverse symptoms among patients with
hormone-receptor positive breast cancer.

About 1 in 8 women are diagnosed with breast cancer during their lifetime; among them over
80% have hormone receptor-positive (HR+) tumors. Long-term aromatase inhibitors are commonly
prescribed to women with HR+ breast cancer after surgery, chemotherapy, and/or radiation to
lower cancer recurrence rates and improve survival. Despite the potential improvement in
survival outcomes, recent evidence suggests that aromatase inhibitor adherence and
persistence rates are low. Multiple studies point to adverse side effects of adjuvant
therapies as a key reason for lower adherence or premature discontinuation. Patients who do
not take the full amount of their medication as prescribed or who discontinue their aromatase
inhibitor treatment early do not receive the full intended treatment benefits, and
consequently are at increased risk for all-cause mortality, cancer death, and recurrence.
Monitoring of adverse effects and symptoms, especially between clinic visits, could help
healthcare providers better manage symptoms and increase long-term treatment adherence.
Evidence indicates that patients generally experience most adverse effects early in their
treatment, typically within the first six months. We plan to enroll 20 subjects per study
arm, for a total of 40 participants. Potential subjects for recruitment will be identified
from the electronic health records system of the West Cancer Center. Physicians and nurses at
the West Cancer Center refer potentially eligible patients to the study nurse coordinator.
The nurse will review eligibility criteria with patients and provide an overview of the
research study and seek informed consent. Patients who provide informed consent will
immediately be asked to complete a brief baseline survey about their preferences for
receiving prompts, either via email or via cell phone using a text message. After survey
administration, all patients will be registered in the mobile health app, which will be used
report medication adherence and any related adverse symptoms. Study participants will be
randomized into one of two arms: 1) active prompts to use the study app or 2) use of study
app, but no prompts. All participants will be followed for a minimum of 6-8 weeks (depending
on their scheduled follow-up visits at the center) and will be asked to complete a follow-up
survey during or shortly after their scheduled in-clinic appointment at the end of the study.
Baseline and follow-up questionnaires will collect data on quality of life (FACT-ES), health
literacy, and demographics. The web-based app will be used to ask patients about medication
adherence in the previous 7 days, any new symptoms, or changes in the severity of symptoms.

Inclusion Criteria:

1. Adult female patients (age≥18)

2. Diagnosed with early stage (I-III) HR+ breast cancer

3. New prescription for an aromatase inhibitor

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 weekly symptom reports on the app

Exclusion Criteria:

1. Unable to communicate in English

2. Patients with prior use of adjuvant endocrine therapy will also be excluded

3. Patients concurrently undergoing surgery, chemotherapy or radiation will also be
excluded

4. Current diagnosis of rheumatoid arthritis

5. Chronic daily narcotic usage
We found this trial at
2
sites
1588 Union Avenue
Memphis, Tennessee 38104
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