An Internet-Based Application for Improving Adherence to Endocrine Therapy among Patients with Early Stage Hormone Receptor Positive, HER2-Negative Breast Cancer
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
WINSHIP5532-22 (primary)
NCI-2022-03205
STUDY00004350
Summary
This clinical trial compares an internet-based application (app) intervention to standard of care for the improvement of adherence to endocrine therapy (ET) among patients with early stage hormone receptor-positive HER2-negative breast cancer. ET can significantly reduce the return of the cancer in patients who are compliant with their treatment regimen. Despite this, adherence to ET is poor due to side effects, lack of social support and timely access to clinicians, and poor patient understanding of the necessity and effectiveness of the therapy. An internet-based app may help patients improve their adherence to ET by providing reminders, side effect mitigation strategies available in the educational videos and from contacting providers/ nurse on the research team directly via the app.
Objectives
PRIMARY OBJECTIVE:
I. To evaluate for improvement in adherence to endocrine therapy (ET) with our web-based app in early-stage hormone positive breast cancer.
SECONDARY OBJECTIVES:
I. To assess the feasibility of a web-based app intervention integrating weekly reminders to improve endocrine therapy adherence.
II. To assess if the web-based app will improve patient satisfaction.
III. To evaluate if the use of this app will decrease calls to on-call provider by providing patients with the necessary information they might require to better understand ET via the app.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care.
ARM II: Patients receive access to the app in addition to standard of care for 3-8 months. Through the app, patients receive weekly reminders about hormone therapy, ask patients to report any side effects, direct patients to educational videos that provide tips to help mitigate some of these side effects, and lastly, allow patients to send messages to members of our breast cancer team about any questions patients may have about the side effects they may be experiencing.
After completion of study, patients are followed for a minimum of 3 months.
Eligibility
- Early-stage hormone receptor positive, HER2-negative breast cancer who have completed all recommended (neo)adjuvant chemotherapy, surgery and/or radiation therapy
- Age >= 18
- Started on an aromatase inhibitor or tamoxifen 6 weeks to 6 months prior to time of enrollment
- Access to internet and a smartphone
- Ability to speak English
Treatment Sites in Georgia
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