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 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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{2 4 5 8 9}

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 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]

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]

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]

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]

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 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]

Citations

1. England 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. [2022]

2. England 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. [2022]

3. England 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. [2023]

4. United States 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. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

mHealth Technology as a Help Tool during Breast Cancer Treatment: A Content Focus Group. [2023]

6. England 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. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Development of a Smartphone Program to Support Adherence to Oral Chemotherapy in People with Cancer. [2022]

8. England 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. [2022]

9. Germany 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? [2022]