Clinical trial NCT02957526: Web-Base App To Improve Aromatase Inhibitor Adherence
Official title: Use of an Innovative Mobile Health Application to Improve Health Outcomes for Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: University of Tennessee West Cancer Center
First posted: 2016-11-06
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Aromatase inhibitor adherence using the four-item Morisky Medication Adherence Scale
timeFrame: 6-8 weeks
measure: Aromatase inhibitor adherence using the single item MAR-Scale global question
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Symptom Burden
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Memphis
country: United States
facility: West Cancer Center, MIDTOWN, 1588 Union Ave.
state: Tennessee
city: Memphis
country: United States
facility: West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Ilana Graetz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graetz I, McKillop CN, Stepanski E, Vidal GA, Anderson JN, Schwartzberg LS. Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial. J Cancer Surviv. 2018 Aug;12(4):431-440. doi: 10.1007/s11764-018-0682-z. Epub 2018 Feb 28.