Web-Base App To Improve Aromatase Inhibitor Adherence

NCT02957526 | Completed

• 1 other identifier: 15-04088-XP
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6-8 weeks

Secondary Outcomes (1)

• Symptom Burden

  6-8 weeks

Study Arms (2)

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.

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.

Behavioral: Clinical Alerts

Interventions

Prompts to report symptoms via study app BEHAVIORAL

Weekly prompts to report aromatase inhibitor use in the previous 7 days and treatment-related adverse symptoms via the web-enabled study app.

App

Clinical Alerts BEHAVIORAL

: 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.

App; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead
• University of Tennessee West Cancer Center: collaborator

Study Sites (2)

West Cancer Center, MIDTOWN, 1588 Union Ave.

Memphis, Tennessee, 38104, United States

Location

West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd

Memphis, Tennessee, 38138, United States

Location

Related Publications (1)

• 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.

  PMID: 29492753 DERIVED

Study Officials

• Ilana Graetz, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 7, 2016
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 19, 2018

Record last verified: 2016-10

Locations

US (2)