Breast Neoplasm FemaleAETAPPNCT02957526
Web-Base App To Improve Aromatase Inhibitor Adherence
A study testing Prompts to report symptoms via study app and Clinical Alerts in people with Breast Neoplasm Female, run by University of Tennessee at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Prompts to report symptoms via study app and Clinical Alerts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
West Cancer Center, MIDTOWN, 1588 Union Ave.
Memphis, Tennessee, 38104
West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd
Memphis, Tennessee, 38138
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasm Female
- Being tested
- Prompts to report symptoms via study app, Clinical Alerts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prompts to report symptoms via study appBehavioural
Weekly prompts to report aromatase inhibitor use in the previous 7 days and treatment-related adverse symptoms via the web-enabled study app.
Clinical AlertsBehavioural
: 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.
| Study group | Role | What they receive |
|---|---|---|
| App | Experimental | 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. Receives: Behavioral: Prompts to report symptoms via study app; Behavioral: Clinical Alerts |
| Usual Care | Active comparator | 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. Receives: Behavioral: Clinical Alerts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aromatase inhibitor adherence using the four-item Morisky Medication Adherence Scale
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.
Measured: 6-8 weeks
Aromatase inhibitor adherence using the single item MAR-Scale global question
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.
Measured: 6-8 weeks
Secondary outcomes (1)
Symptom Burden
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.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee West Cancer Center
- Responsible party
- Sponsor
- Investigators
- Ilana Graetz, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957526
- Sponsor's protocol ID
- 15-04088-XP
- Acronym
- AETAPP
- Status last verified
- Oct 2016
- First submitted
- 31 Oct 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29492753
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Innovative Mobile Health Application to Improve Health Outcomes for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02957526
- Acronym / sponsor ID
- AETAPP / 15-04088-XP
- Conditions
- Breast Neoplasm Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- University of Tennessee West Cancer Center
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App | Experimental | Behavioral: Prompts to report symptoms via study app, Behavioral: Clinical AlertsThe 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. |
| Usual Care | Active comparator | Behavioral: Clinical AlertsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prompts to report symptoms via study appWeekly prompts to report aromatase inhibitor use in the previous 7 days and treatment-related adverse symptoms via the web-enabled study app. | Behavioural | App |
| Clinical Alerts: 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. | Behavioural | App, Usual Care |
Primary outcome
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.
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.
1 secondary outcome
Symptom Burden
Time frame: 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Derived from this study: PubMed 29492753Graetz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilana Graetz, PhD principal investigator
University of Tennessee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prompts to report symptoms via study app and Clinical Alerts in people with Breast Neoplasm Female, run by University of Tennessee at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aromatase inhibitor adherence using the four-item Morisky Medication Adherence Scale (time frame: 6-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.