30 Participants Needed

Internet-Based App for Breast Cancer Treatment Adherence

Recruiting at 3 trial locations
DK
JL
JL
Overseen ByJane L. Meisel, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
Must be taking: Aromatase inhibitors, Tamoxifen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it focuses on improving adherence to endocrine therapy, so you will likely need to continue taking your prescribed endocrine therapy medications.

What data supports the effectiveness of the Internet-Based App for Breast Cancer Treatment Adherence?

Research shows that using a web-based app to manage symptoms and communicate with healthcare teams can improve adherence to breast cancer treatments by helping patients manage side effects better. Similar digital tools have been effective in increasing adherence to cancer therapies by providing reminders and facilitating communication with healthcare providers.12345

Is the Internet-Based App for Breast Cancer Treatment Adherence safe for humans?

The web-based app has been used in studies to help manage symptoms and improve adherence to breast cancer treatments, and no specific safety concerns have been reported in these studies.14567

How is the Internet-Based App for Breast Cancer Treatment Adherence different from other treatments?

The Internet-Based App for Breast Cancer Treatment Adherence is unique because it uses a digital platform to help patients manage symptoms and adhere to their medication schedule by providing real-time symptom reporting and reminders, which can be shared with healthcare providers for timely intervention.14689

What is the purpose of this trial?

This clinical trial looks at the use of an internet-based application (app) intervention in improving 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.

Research Team

Jane L. Meisel, MD | Winship Cancer ...

Jane L Meisel

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with early-stage hormone receptor-positive, HER2-negative breast cancer who've finished recommended treatments and started on aromatase inhibitors or Tamoxifen within the last six months. Participants need internet access and must speak English.

Inclusion Criteria

Access to internet from a desktop or a smartphone
I started taking an aromatase inhibitor or Tamoxifen less than 6 months ago.
I have early-stage, hormone receptor positive, HER2-negative breast cancer and have completed all recommended treatments.

Exclusion Criteria

My cancer is HER2 positive.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to a web-based app for 3 months to improve adherence to endocrine therapy

12 weeks
Weekly virtual interactions via app

Follow-up

Participants are monitored for adherence and satisfaction with the app and endocrine therapy

Up to 1 year

Treatment Details

Interventions

  • Web Based App Intervention
Trial Overview The study tests a web-based app designed to help patients stick to their endocrine therapy. It includes features like medication reminders, educational videos about side effect management, and direct contact with healthcare providers.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single Arm (internet intervention, best practice)Experimental Treatment4 Interventions
Patients receive access to the app in addition to standard of care for 3 months. Through the app, patients receive weekly reminders about hormone therapy, report any side effects, access educational videos that provide tips to help mitigate some of these side effects, and 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

A randomized controlled trial involving 300 women with early-stage, hormone receptor-positive breast cancer is testing a web-enabled app designed to improve adherence to adjuvant endocrine therapy (AET) by managing symptoms and providing feedback.
The study aims to assess the app's impact on medication adherence, symptom burden, and quality of life over six months, with a focus on addressing racial disparities in breast cancer outcomes.
THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer.Paladino, AJ., Anderson, JN., Krukowski, RA., et al.[2022]
The ONCO-TreC platform, which includes a mobile app for patients and a web dashboard for healthcare professionals, is being tested in a randomized controlled trial to see if it improves adherence to oral cancer therapy compared to a standard paper diary.
The study will involve 136 patients over six cycles of therapy, measuring adherence through pill counts, with the goal of reducing non-adherence rates significantly in the electronic diary group.
Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial.Passardi, A., Serra, P., Caffo, O., et al.[2022]
A new digital health application for breast cancer patients in Mexico will be tested to improve patient-centered care by monitoring electronic patient-reported outcomes (ePROs) and providing proactive follow-up by nurses, with a pilot test involving 50 patients over 6 weeks.
The main study will include 205 patients in a randomized controlled trial over 6 months, aiming to assess supportive care needs and quality of life, with results expected to inform future cancer care practices in Mexico.
Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial.Contreras Sánchez, SE., Doubova, SV., Grajales Álvarez, R., et al.[2023]

References

THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer. [2022]
Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial. [2022]
Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial. [2023]
Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial. [2020]
mHealth Technology as a Help Tool during Breast Cancer Treatment: A Content Focus Group. [2023]
Impact of web application support versus standard management on adherence with adjuvant hormone therapy in patients treated for breast cancer: the WEBAPPAC study. [2023]
Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. [2022]
A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. [2022]
Providers' Perspectives on Adherence to Hormonal Therapy in Breast Cancer Survivors. Is there a Role for the Digital Health Feedback System? [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security