EveryDose App for Cancer

Overseen By Jessica MacIntyre, DNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: Oral anti-cancer

Disqualifiers: Under 18, Dementia, Major psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn about the experiences of cancer patients during treatment utilizing a mobile app called EveryDose© to track prescribed oral treatment for cancer. Based on these experiences, the study team will decide on expanding this pilot study to evaluate other methods that may prove to be beneficial in supporting cancer patient's ability to take cancer medications as prescribed (another common phrase used for this is adherence to treatment).

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it requires that you are prescribed an oral anti-cancer drug as your first treatment, so you may need to discuss your current medications with the study team.

What data supports the effectiveness of the EveryDose Mobile Application treatment for cancer?

Research shows that mobile apps can help patients stick to their cancer treatment plans and manage symptoms better, which can improve their quality of life and potentially increase survival rates. ^{1 2 3 4 5}

Is the EveryDose App for Cancer safe for use in humans?

The EveryDose App is designed to help detect and manage side effects from cancer treatments early, which can improve patient safety and outcomes. It has been tested in a study to see if it can help track and report side effects effectively, aiming to enhance the safety of cancer treatments. ^{4 6 7 8 9}

How does the EveryDose App for Cancer differ from other treatments for cancer?

The EveryDose App for Cancer is unique because it leverages mobile technology to support cancer treatment, focusing on early diagnosis and managing side effects, which is different from traditional drug-based treatments. This app-based approach allows for remote monitoring and personalized care, offering a novel way to enhance patient engagement and adherence to treatment plans. ^{4 10 11 12 13}

Research Team

Frank Penedo, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for cancer patients who are currently prescribed oral chemotherapy. Participants should be willing to use the EveryDose mobile app to track their medication intake and share their experiences with the research team.

Inclusion Criteria

I am starting my first oral cancer drug as the only treatment.

Internet access on a smartphone, tablet, or computer

I can sign a consent form.

Exclusion Criteria

I can read and understand either English or Spanish.

Unable to provide written informed consent

History of dementia or major psychiatric disease that would interfere with study participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the EveryDose mobile application to track prescribed oral treatment for cancer

12 weeks

Regular app usage

Follow-up

Participants are monitored for satisfaction and adherence post-intervention

4 weeks

Treatment Details

Interventions

• EveryDose Mobile Application

Trial Overview The FOCUS study is testing how effective the EveryDose mobile application is in helping cancer patients manage and adhere to their oral chemotherapy treatment schedules.

Participant Groups

Group I: EveryDose Mobile Application Group Experimental Treatment 1 Intervention

Participants in this group will use the EveryDose mobile application for up to 12 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

A study involving 4475 breast cancer patients showed that using a smartphone app significantly improved adherence to multidisciplinary treatment (MDT) recommendations, with a notable reduction in noncompliance rates from 27.4% in 2013 to 8.8% in 2019.

Patients who used the app were 39% less likely to deviate from MDT recommendations compared to those who did not use the app, particularly improving compliance with adjuvant chemotherapy and radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone-Based App to Improve Adjuvant Treatment Adherence to Multidisciplinary Decisions in Patients With Early-Stage Breast Cancer: Observational Study. Yu, J., Wu, J., Huang, O., et al.[2021]

The self-assessment smartphone app alerted 72.6% of users about concerning symptoms related to tobacco-induced diseases, with current smokers showing a higher incidence of symptoms like fatigue and cough, indicating a significant awareness of health issues.

During the study, the incidence of early-stage lung cancer (stages 1 and 2) increased to 24% among users, compared to 9% in the previous year, suggesting that the app may enhance early detection of lung cancer and encourage smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. Stavaux, E., Goupil, F., Barreau, G., et al.[2023]

A pilot study involving 40 women with breast cancer showed that using a symptom management mobile application alongside usual care led to better quality of life and lower severity of depression compared to those receiving only usual care.

The intervention group experienced less decline in general health and physical functioning during chemotherapy, suggesting that the mobile app may effectively support emotional and physical well-being during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Application for Symptom Management in Patients With Breast Cancer. Seven, M., Paşalak, Ş., Bagcivan, G., et al.[2022]

A systematic review of 54 articles over the last 10 years found that mobile apps for cancer management are increasingly being researched, particularly for early detection, with a focus on melanoma.

Despite the growth in studies, many of the apps developed for cancer management tend to be removed from app stores after the research is completed, making it difficult for users to access them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications in oncology: A systematic review of health science databases. Ana, FA., Loreto, MS., José, LM., et al.[2020]

Mobile health monitoring allows patients with long-term conditions, like type 2 diabetes and cancer, to actively manage their medication dosages, leading to better patient care.

Studies showed that patients could effectively self-titrate their oral glucose-lowering medications and insulin, as well as adjust chemotherapy doses, with high compliance and safety through regular monitoring of their health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health for drug dose optimisation. Larsen, ME., Farmer, A., Weaver, A., et al.[2020]

The study aims to evaluate a smartphone application designed for real-time reporting of adverse events in cancer treatments, which could enhance early detection and management of side effects, ultimately improving patient safety and treatment outcomes.

The trial will involve 66 patients over six months, assessing the feasibility of the app and comparing the quality of life and therapy doses between those using the app and those receiving standard care, highlighting the importance of patient-reported symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. Kestler, AMR., Kühlwein, SD., Kraus, JM., et al.[2021]

The eOncosalud app was used by 186 cancer outpatients receiving oral antineoplastic agents, allowing for real-time monitoring and early detection of adverse effects (AEs), with a total of 1,368 AEs recorded, including fatigue and diarrhea as the most common.

The app's algorithm provided automatic recommendations for managing AEs, with a positive predictive value of 51% for emergency room visits, demonstrating its effectiveness in optimizing healthcare resources and improving patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone app to improve the safety of patients undergoing treatment with oral antineoplastic agents: 4 years of experience in a university hospital. Villanueva-Bueno, C., Collado-Borrell, R., Escudero-Vilaplana, V., et al.[2023]

Mobile applications can effectively help manage chemotherapy-related side effects in early breast cancer patients, as shown in four out of six apps reviewed, leading to improved quality of life and reduced symptom burden.

While these apps show promise in enhancing symptom monitoring during treatment, further research is necessary to confirm their effectiveness and safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications for early breast cancer chemotherapy-related symptoms reporting and management: A scoping review. Suchodolska, G., Senkus, E.[2022]

Out of 776 health apps identified for supporting breast cancer treatment and aftercare, only 12 were classified as partially recommended and just 3 as recommended, indicating that most apps do not meet quality standards for patient support.

The evaluation criteria included user assessments and scientific benefits, highlighting that while some apps may offer potential benefits for breast cancer patients, the majority lack sufficient quality and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications Available in Germany Supporting Breast Cancer Patients During Treatment and Aftercare: a Systematic Review. Gomm, SIM., Ebner, FK., Lukac, S., et al.[2023]

A study evaluated 457 mobile health applications (MHAs) for prostate cancer antigen (PSA) dosage, finding that only 24 met the criteria for quality assessment, with an overall mean score below the acceptable threshold.

The quality of these apps was generally low, but well-developed MHAs could enhance PSA screening efforts and improve access to care, especially for patients in rural areas, potentially leading to earlier detection and treatment of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile health application for prostate cancer antigen dosage: is it time to say goodbye to classic screening methods? Di Bello, F., di Mauro, E., Fusco, GM., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Smartphone-Based App to Improve Adjuvant Treatment Adherence to Multidisciplinary Decisions in Patients With Early-Stage Breast Cancer: Observational Study. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Mobile Application for Symptom Management in Patients With Breast Cancer. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Mobile applications in oncology: A systematic review of health science databases. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Mobile health for drug dose optimisation. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility study of a web application for self-report of anticancer treatment toxicities. [2013]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A smartphone app to improve the safety of patients undergoing treatment with oral antineoplastic agents: 4 years of experience in a university hospital. [2023]

9. Spain pubmed.ncbi.nlm.nih.gov

[Utility of the Abeona Health® app for patient participation in the identification of chemotherapy-induced toxicity according to the CTCAE classification]. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Landscape Analysis of Oncology Mobile Health Applications. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile applications for early breast cancer chemotherapy-related symptoms reporting and management: A scoping review. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Mobile Applications Available in Germany Supporting Breast Cancer Patients During Treatment and Aftercare: a Systematic Review. [2023]

13. England pubmed.ncbi.nlm.nih.gov

A mobile health application for prostate cancer antigen dosage: is it time to say goodbye to classic screening methods? [2023]