Mobile Health App for Breast Cancer

Overseen By Lauren Matthews

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Dementia, Psychiatric condition, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app (mHealth app) to evaluate its effectiveness in assisting Black or African American women with breast cancer during their treatment journey. The app educates users about clinical trials and connects them to nearby trial opportunities. Participants will use the app alongside their usual care resources. The trial seeks African American women diagnosed with breast cancer who speak English and have access to a smartphone or computer. As an unphased trial, participants contribute to innovative research that may enhance access to clinical trials for others.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this app is safe for use in breast cancer patients?

Research shows that mobile health (mHealth) apps for breast cancer are generally well-received. No direct evidence of safety concerns exists for the specific app in this study. However, similar apps have been researched before, focusing on usability and patient effects, without finding major safety issues.

For example, one study found that a breast cancer management app was practical and helped boost patients' confidence in managing their health. Another study showed that mobile apps for breast cancer can effectively provide medical information and social support during treatment.

Although specific safety data for this app is unavailable, the absence of common safety issues in similar apps suggests it is likely safe to use. This mHealth app primarily facilitates information sharing and communication, which usually involves low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth app for breast cancer because it offers a personalized and tech-savvy approach to managing the disease. Unlike traditional treatments, which generally involve chemotherapy, radiation, or surgery, this app empowers patients by providing easy access to a list of clinical trials within a 50-mile radius of their location. It supplements the existing standard of care by integrating digital resources, making it easier for patients to navigate their treatment options and find additional support. This innovative use of mobile technology aims to enhance patient engagement and potentially improve outcomes by connecting them to cutting-edge research opportunities.

What evidence suggests that the mHealth app is effective for breast cancer?

Research shows that mobile health apps can greatly assist people in managing breast cancer. Studies have found that these apps boost confidence in handling health. They provide personalized information and help track symptoms, which benefits patients. In this trial, participants will access the "mHealth" app, offering a list of available clinical trials within a 50-mile radius of their zip code, along with the standard care packet of cancer center resources. One app, CAMA, has been particularly effective in supporting patients with self-care routines. Overall, these apps offer valuable support that can positively impact those dealing with breast cancer. ^{4 5 6 7 8}

Who Is on the Research Team?

Marjory Charlot, MD, MPH, MSc

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is specifically for Black or African American women who have been diagnosed with breast cancer. It aims to understand how a mobile health app can fit into clinical settings and help these women learn about and participate in breast cancer trials.

Inclusion Criteria

Identify as African American

Have access to a mobile device or computer

I am willing and able to complete the survey.

Exclusion Criteria

I am mentally capable of understanding and giving informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive access to the mHealth app and a list of available clinical trials, along with standard care resources

Up to 1 year

Follow-up

Participants are monitored for feasibility and satisfaction with the mHealth app

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• mHealth app

Trial Overview

The study is testing the 'mHealth app,' which provides educational resources and communication tools about breast cancer clinical trials. The focus is on its practicality, effect on clinic operations, and user satisfaction among participants.

How Is the Trial Designed?

Group I: mHealth app Experimental Treatment 2 Interventions

Women enrolled in the mHealth app study will receive access to the "mHealth" app, a list of available clinical trials within a 50-mile radius of their zip code, and the existing standard of care packet of cancer center resources.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Conquer Cancer Foundation

Collaborator

Trials

22

Recruited

4,000+

Published Research Related to This Trial

A systematic review identified 599 breast cancer apps from major smartphone app stores, with the majority being free and primarily focused on disease information, management, and awareness.

Most apps lack a solid evidence base, with only 24.54% including usage disclaimers and less than 20% citing references, highlighting the need for expert involvement in app development to ensure safety and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A biopsy of Breast Cancer mobile applications: state of the practice review. Giunti, G., Giunta, DH., Guisado-Fernandez, E., et al.[2022]

Out of 302 breast cancer apps identified, only 30 (9.9%) effectively supported behavior change, primarily focusing on early detection rather than comprehensive cancer care management.

Apps with star ratings were found to include significantly more behavior change techniques, highlighting a potential link between user ratings and the effectiveness of the app's design in promoting health behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Evidence-Based Best Practices and Behavior Change Techniques in Breast Cancer Apps: Systematic Analysis. Kalke, K., Ginossar, T., Bentley, JM., et al.[2021]

The study reviewed 676 research articles and identified 8 relevant studies, highlighting the importance of involving patients and healthcare professionals in the design and development of mobile health applications (mHealth apps) for breast cancer care.

There is a promising potential for mHealth apps to improve care for breast cancer patients, but systematic efforts are needed to develop and validate these apps, focusing on patient characteristics and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health applications for the care of patients with breast cancer: A scoping review. Cai, T., Huang, Y., Zhang, Y., et al.[2022]

An educational m-Health app designed to improve resilience in breast cancer patients received a high usability score of 83.20, indicating strong user satisfaction and potential for recommendation among cancer survivors.

The app was found to be effective and usable across all age groups and educational backgrounds, suggesting it can be a valuable resource for a diverse range of breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, usability and quality evaluation of the resilient mobile application for women with breast cancer. Rezaee, R., Asadi, S., Yazdani, A., et al.[2022]

A review of 101 breast cancer-related mobile apps revealed that while they provide valuable educational content, the majority focus on outdated practices like breast self-examination, which is no longer recommended as a primary screening method.

Most apps did not adhere to usability and health literacy standards, indicating a need for improvement in app design to ensure they are accessible and informative for diverse populations, particularly in areas like survivorship and end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content, Usability, and Utilization of Plain Language in Breast Cancer Mobile Phone Apps: A Systematic Analysis. Ginossar, T., Shah, SF., West, AJ., 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]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., 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]

Breast cancer patients often engage in low levels of physical activity during chemotherapy, which can negatively impact their health and recovery.

A Mobile Physical Activity Program was developed to encourage physical activity through a mobile app, offering features like disease tracking and health behavior recording, which could help improve patient engagement and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Physical Activity Intervention for Breast Cancer Patients During Chemotherapy. Geng, Z., Wu, F., Zhang, Y., et al.[2018]

The mobile app 'AMOR Mama' was evaluated by 8 healthcare professionals and was found to be suitable for guiding and monitoring breast cancer patients undergoing radiation therapy, with a high concordance index of 80% for most features.

The app's usability for users of different educational levels was the only area needing improvement, indicating that while the app is effective, further refinements could enhance accessibility for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App (AMOR Mama) for Women With Breast Cancer Undergoing Radiation Therapy: Functionality and Usability Study. Cruz, FOAMD., Faria, ET., Ghobad, PC., et al.[2021]

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]

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]

Mobile health (mHealth) applications have shown a high usage rate of over 80% among cancer patients, particularly benefiting adherence and health outcomes through features like guided supervision and personalized suggestions.

Despite their potential, challenges such as cancer progression and technical difficulties can lead to dropouts, highlighting the need for improved design and verification of mHealth interventions to better support cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review and a Taxonomy to Assess the Impact of Mobile Apps on Cancer Care Management. Dhar, E., Bah, AN., Chicchi Giglioli, IA., et al.[2023]

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