- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02957526
Web-Base App To Improve Aromatase Inhibitor Adherence (AETAPP)
July 17, 2018 updated by: University of Tennessee
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38104
- West Cancer Center, MIDTOWN, 1588 Union Ave.
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Memphis, Tennessee, United States, 38138
- West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Adult female patients (age≥18)
- Diagnosed with early stage (I-III) HR+ breast cancer
- New prescription for an aromatase inhibitor
- Have a mobile device with a data plan or a home computer with Internet
- Have a valid email address
- Willing to complete brief weekly symptom reports on the app
Exclusion Criteria:
- Unable to communicate in English
- Patients with prior use of adjuvant endocrine therapy will also be excluded
- Patients concurrently undergoing surgery, chemotherapy or radiation will also be excluded
- Current diagnosis of rheumatoid arthritis
- Chronic daily narcotic usage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: App
The web-based app will be used to ask participants about their aromatase inhibitor use in the previous 7 days and ask about treatment-related adverse symptoms, or changes in the severity of symptoms.
Participants will receive reminders via text or email to use the app once per week.
All participants will be followed for a 6-8 weeks (depending on the data of participants' in-clinic follow-up visit) and will be asked to complete a baseline survey at enrollment and a follow-up survey at their 6-8 week in-clinic follow-up visit.
|
Weekly prompts to report aromatase inhibitor use in the previous 7 days and treatment-related adverse symptoms via the web-enabled study app.
: Reported symptoms may trigger an email alert to the participant's care team based on predetermined thresholds.
Alerts based on certain response thresholds are generated to inform the patient's care team of any concerning responses or trends that emerge from the patient reported outcomes.
These alerts will inform providers of particular patient-related adverse events or symptoms requiring an intervention prior to the point that emergent medical care is needed.
Information in the alert emails will include the participant's Medical Reference Number (MRN), initials, date of birth, and details about the symptom(s) that generated the alert.
Pod nurses instructed to respond to any clinical alerts (sent via email) as soon as possible following standard of care.
|
Active Comparator: Usual Care
Participants will have access to the web-based app, but will not receive reminders.
All participants will be followed for a 6-8 weeks (depending on the data of participants' in-clinic follow-up visit) and will be asked to complete a baseline survey at enrollment and a follow-up survey at their 6-8 week in-clinic follow-up visit.
|
: Reported symptoms may trigger an email alert to the participant's care team based on predetermined thresholds.
Alerts based on certain response thresholds are generated to inform the patient's care team of any concerning responses or trends that emerge from the patient reported outcomes.
These alerts will inform providers of particular patient-related adverse events or symptoms requiring an intervention prior to the point that emergent medical care is needed.
Information in the alert emails will include the participant's Medical Reference Number (MRN), initials, date of birth, and details about the symptom(s) that generated the alert.
Pod nurses instructed to respond to any clinical alerts (sent via email) as soon as possible following standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aromatase inhibitor adherence using the four-item Morisky Medication Adherence Scale
Time Frame: 6-8 weeks
|
The primary data analysis will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization.
Investigators will measure differences in aromatase inhibitor adherence at end of the study between the two study arms using the four-item Morisky Medication Adherence Scale.
|
6-8 weeks
|
Aromatase inhibitor adherence using the single item MAR-Scale global question
Time Frame: 6-8 weeks
|
The primary data analysis will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization.
Investigators will measure differences in aromatase inhibitor adherence at end of the study between the two study arms using the Medication Reasons Adherence (MAR-Scale) single item global question which asks about medication adherence in the past 7 days.
|
6-8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom Burden
Time Frame: 6-8 weeks
|
Investigators also plan to carry out a secondary analysis, which will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization.
Investigators will measure relative changes in adverse symptom burden (measured using surveys collected at baseline and at follow-up 6-8 weeks after the intervention using the FACT-ES questionnaire) between the two study arms.
|
6-8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ilana Graetz, PhD, University of Tennessee Health Science Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
October 31, 2016
First Submitted That Met QC Criteria
November 3, 2016
First Posted (Estimate)
November 6, 2016
Study Record Updates
Last Update Posted (Actual)
July 19, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-04088-XP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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