An Internet-Based Application for Improving Adherence to Endocrine Therapy among Patients with Early Stage Hormone Receptor Positive, HER2-Negative Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT05488145
Trial Phases:		Protocol IDs:	WINSHIP5532-22 (primary) NCI-2022-03205 STUDY00004350
Eligibility:	18 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05488145

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.

Treatment Sites in Georgia

Emory Johns Creek Hospital
6325 Hospital Parkway
Johns Creek, GA 30097
www.emoryjohnscreek.com

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.