Internet-Based App for Breast Cancer Treatment Adherence

Recruiting at 3 trial locations

Overseen By Jane L. Meisel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Aromatase inhibitors, Tamoxifen

Disqualifiers: Her2 neu positive

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an internet-based app designed to help individuals adhere to hormone therapy for early-stage hormone receptor-positive, HER2-negative breast cancer. Hormone therapy can significantly reduce the risk of cancer recurrence, but many struggle with treatment due to side effects and lack of support. The app offers reminders, educational videos, and a way to contact healthcare providers, making therapy management easier. Individuals who have completed initial cancer treatments and started hormone therapy in the past six months might be suitable candidates, especially if they have internet access and speak English. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions that support ongoing cancer treatment.

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 prior data suggests that this internet-based app is safe for improving treatment adherence?

Research has shown that using a web-based app can help manage symptoms and improve communication with healthcare teams, leading to better adherence to breast cancer treatments. Another study found that digital programs can increase patients' confidence in managing their care and sticking to their medication plans.

Importantly, these apps are generally easy to use. They do not involve taking any new medication, so there are fewer concerns about side effects. Instead, they help patients stay on track with their current treatments by offering reminders and educational support.

Overall, using a web-based app for treatment support is considered safe for patients. It aims to make it easier for people to follow their prescribed therapies and feel more supported along the way. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional breast cancer treatments that focus solely on medication, the web-based app intervention is unique because it integrates technology to enhance treatment adherence and patient support. This app offers weekly reminders for taking hormone therapy, provides educational videos to help manage side effects, and allows direct communication with healthcare professionals. Researchers are excited about this approach because it actively involves patients in their care, potentially improving adherence to treatment plans and ultimately leading to better health outcomes.

What evidence suggests that this app is effective for improving adherence to breast cancer treatment?

Research has shown that using a web-based app can help patients adhere to their breast cancer treatment plans. In this trial, participants will access an internet-based app intervention alongside standard care. Studies have found that these apps simplify symptom management and timely medication intake. One study found that an app increased both treatment satisfaction and adherence by enabling patients to report symptoms and communicate with their healthcare team. Another study showed that a similar app boosted patients' confidence in self-care. These apps offer reminders and educational videos, aiding patients in understanding their treatment and managing side effects. ^{1 2 6 7 8}

Who Is on the Research Team?

Jane L Meisel

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Single Arm (internet intervention, best practice) Experimental Treatment 4 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.

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+

Published Research Related to This Trial

A pilot study involving 44 postmenopausal women with hormone receptor-positive breast cancer showed that using a web-based app with weekly reminders significantly improved adherence to aromatase inhibitors (AIs) at 8 weeks (100% vs. 72% adherence).

The App+Reminder group also had a higher usage rate of the app (74% vs. 38%), suggesting that reminders can help patients manage their treatment better, potentially leading to better long-term outcomes in cancer survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial. Graetz, I., McKillop, CN., Stepanski, E., et al.[2020]

A study involving interviews with healthcare providers revealed that communication barriers, such as patients not disclosing medication discontinuation, significantly impact adherence to hormonal therapy in ER positive breast cancer patients.

The Digital Health Feedback System (DHFS) could improve medication adherence by providing better tracking and reminders, although concerns about the safety of ingesting the sensor were noted as a barrier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providers' Perspectives on Adherence to Hormonal Therapy in Breast Cancer Survivors. Is there a Role for the Digital Health Feedback System? de Mendoza, AH., Cabling, M., Dilawari, A., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Breast Cancer e-Support mobile app is designed to improve self-efficacy, social support, and symptom management for women undergoing chemotherapy, with a study involving 108 participants to assess its effectiveness over 6 months.

This study is the first in China to rigorously evaluate a mobile app intervention for breast cancer patients, aiming to enhance their quality of life and psychological well-being through tailored support and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Zhu, J., Ebert, L., Liu, X., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Xemio app, designed for breast cancer patients, was found to be beneficial for tracking side effects and providing reliable disease information, which can enhance patient knowledge and treatment adherence.

Participants highlighted the importance of ease of use and expressed a desire for healthcare providers to inform them about the app, indicating that accessibility and communication are crucial for the successful implementation of mHealth tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Technology as a Help Tool during Breast Cancer Treatment: A Content Focus Group. Fuentes, A., Amat, C., Lozano-Rubí, R., et al.[2023]

The WEBAPPAC trial is a phase 3 study involving 438 breast cancer patients that aims to evaluate the effectiveness of a web-application in improving adherence to hormone therapy, which is crucial for reducing the risk of disease recurrence.

The study will assess not only adherence rates but also the management of adverse drug reactions and overall quality of life, highlighting the importance of patient support in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of web application support versus standard management on adherence with adjuvant hormone therapy in patients treated for breast cancer: the WEBAPPAC study. Gernier, F., Grellard, JM., Dupont, C., et al.[2023]

A smartphone self-management program was developed to improve adherence to oral chemotherapy in cancer patients, addressing key issues like forgetfulness, side effects, and lack of knowledge about treatment.

The program includes features like medication reminders and tailored information delivery, primarily through simple text messages, based on feedback from end-users, which may enhance its effectiveness in supporting patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. Skrabal Ross, X., Gunn, KM., Patterson, P., et al.[2022]

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In this randomized clinical trial of 304 women, a remote monitoring app combined with text messages did not improve AET adherence in the first year.