App for Monitoring Chemotherapy Side Effects in Breast Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Julie Lemieux

Must be taking: Palbociclib, Everolimus, Capecitabine

Disqualifiers: Cognitive impairments

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app designed to help patients track side effects from oral chemotherapy treatments for breast cancer. The app aims to simplify reporting of symptoms and assist healthcare providers in managing issues, potentially improving patient care and treatment adherence. Individuals with metastatic breast cancer who are currently taking oral chemotherapy and have access to a smartphone, tablet, or computer may be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to innovative solutions that could enhance their treatment experience.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it requires participants to be receiving oral chemotherapy like palbociclib, everolimus, or capecitabine.

What prior data suggests that this app is safe for monitoring chemotherapy side effects?

Research shows that smartphone apps for tracking chemotherapy side effects can make oral cancer drugs safer for patients. One study found that an app called eOncosalud allowed for close, real-time monitoring. This app used smart technology to provide automatic advice, which improved side effect management.

Another study, ENABLE, used a mobile app to record patients' quality of life and any side effects they experienced. While these apps help track side effects, solid proof is lacking that they improve adherence to treatment plans.

Overall, these apps are generally easy for patients to use without major problems. Although more research is needed to fully understand their benefits, current evidence suggests they are safe for monitoring side effects in cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the app for monitoring chemotherapy side effects in breast cancer because it offers a new approach to managing treatment. Unlike traditional methods that rely on patients verbally reporting side effects during doctor visits, this app allows for real-time tracking and reporting of adverse events from oral chemotherapy. This can lead to more timely interventions and personalized care, potentially improving patient outcomes and comfort. By leveraging digital technology, the app aims to enhance communication between patients and healthcare providers, making cancer treatment more responsive and efficient.

What evidence suggests that this app is effective for monitoring chemotherapy side effects in breast cancer?

Research shows that using an app to manage side effects from oral chemotherapy can help patients take a more active role in their treatment. This trial will evaluate an app specifically designed for monitoring adverse events related to oral chemotherapy. Some studies have found that these types of apps can improve how patients report and manage symptoms related to their treatment. For example, one study found that a well-designed mobile app helped patients stick to their treatment plan and manage symptoms better. Although some apps did not significantly improve overall adherence, they still aided patients who struggled with following their treatment plan. Overall, these digital tools can support patients in managing their health more effectively. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic breast cancer who are currently taking oral chemotherapy drugs like palbociclib, everolimus, or capecitabine. Participants need to have a smartphone, tablet, or computer. Those with cognitive impairments cannot join.

Inclusion Criteria

You must have breast cancer that has spread to other parts of the body.

Possess a smartphone, a tablet, or a personal computer

You have been diagnosed with advanced breast cancer that has spread to other parts of the body.

Exclusion Criteria

You have problems with memory or thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use an app to self-report side effects of oral chemotherapy for breast cancer

3 months

Regular app usage and self-reporting

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• App for Adverse Events to Oral Chemotherapy

Trial Overview The study is testing an app designed to help patients self-report side effects from oral chemotherapy treatments. The goal is to see if this can improve patient care and safety by providing systematic monitoring outside of the hospital setting.

How Is the Trial Designed?

Group I: Application Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Julie Lemieux

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK596248/

Does a Smartphone App Help Patients with Cancer Take Oral ... Across all patients, the mobile app was not efficacious in improving adherence or symptoms. However, patients at greater risk for nonadherence may benefit.

2. researchprotocols.org researchprotocols.org/2025/1/e69855

ENABLE—App-Based Digital Capture and Intervention of ... The ENABLE trial digitally recorded the health-related quality of life (HRQoL), adverse events (AEs), and patient satisfaction using a mobile smartphone app.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6054536/

Use of a Web-based App to Improve Breast Cancer ... Our study found that a web-based mobile app with weekly reminders for real-time reporting of AI adherence and treatment-related adverse symptoms was feasible ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820436

Remote Monitoring App for Endocrine Therapy Adherence ... There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388921000752

The effect of a mobile application on treatment adherence ... The present study results showed that the mobile application is effective in managing symptoms and increasing treatment adherence. A well-designed mobile health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9672512/

A smartphone app to improve the safety of patients ... The eOncosalud app enables close, real-time monitoring of patients treated with OAA. The automatic recommendations through the app's algorithm ...

7. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074825003038

ENABLE—App-Based Digital Capture and Intervention of ... ENABLE—App-Based Digital Capture and Intervention of Patient-Reported Quality of Life, Adverse Events, and Treatment Satisfaction in Breast ...