Mobile Health for Breast Cancer

Recruiting at 387 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ECOG-ACRIN Cancer Research Group

Must be taking: CDK4/6 inhibitors

Disqualifiers: ECOG status >= 3, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

410 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on patients who are taking CDK4/6 inhibitors, so you should continue taking these as prescribed.

What data supports the effectiveness of the treatment Patient Navigation, Patient Navigation Services, Care Coordination, Healthcare Navigation for breast cancer?

Research shows that patient navigation can improve breast cancer care, especially for disadvantaged women, by helping them follow up on abnormal mammograms. Additionally, using patient navigators has been shown to improve the quality of breast cancer care, increasing adherence to care standards from 69% to 86%. ^{1 2 3 4 5}

Is patient navigation safe for humans?

The research articles do not provide specific safety data for patient navigation or mobile health apps, but they focus on improving care and access for breast cancer patients, suggesting that these programs are generally considered safe and beneficial. ^{4 5 6 7 8}

How is the treatment Patient Navigation unique for breast cancer patients?

Patient Navigation is unique because it focuses on guiding breast cancer patients through the healthcare system, improving care coordination and accessibility, especially for underserved populations. Unlike traditional treatments that directly target cancer cells, this approach uses mobile health (mHealth) apps to support patients and caregivers, ensuring timely and patient-centered care. ^{4 9 10 11 12}

Research Team

Gelareh Sadigh

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for metastatic breast cancer patients taking CDK4/6 inhibitors, fluent in English or Spanish, and healthcare providers involved with such patients. Patients must have started treatment within 30 days before joining or plan to start soon after. Providers need experience with a patient on CONCURxP who had less than 85% adherence.

Inclusion Criteria

I am fluent in English or Spanish, both written and spoken.

You are a non-patient and able to communicate in English.

I have had cancer treatments, but not CDK4/6 inhibitors.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the WiseBag medication dispenser and receive either enhanced usual care or the CONCURxP platform over 12 months

12 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for adherence, symptom burden, and quality of life after treatment

6 months

Treatment Details

Interventions

• Patient Navigation

Trial Overview The study tests the effectiveness of the CONCURxP platform, which includes a medication monitoring device (WiseBag) and text reminders, against enhanced usual care using only WiseBag to improve medication adherence in metastatic breast cancer patients.

Participant Groups

Group I: ARM C (Non-patient interview) Experimental Treatment 1 Intervention

Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment.

Group II: ARM B (CONCURxP program) Experimental Treatment 6 Interventions

Patients use the WiseBag medication dispenser and receive personalized text message reminders, medication tracking and healthcare provider follow ups as part of the CONCURxP platform over 12 months. Patients may complete an interview over 20-30 minutes within 6 months of study completion.

Group III: ARM A (Enhanced usual care) Experimental Treatment 4 Interventions

Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months.

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A patient navigation (PN) program significantly improved follow-up care for disadvantaged women with abnormal mammograms, with 90.4% receiving appropriate follow-up compared to 75.3% in practices without PN.

Women in the PN program also experienced quicker follow-up times, especially for BI-RADS 3 findings, where the likelihood of timely follow-up was more than double compared to non-PN practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. Percac-Lima, S., Ashburner, JM., McCarthy, AM., et al.[2018]

The implementation of a patient navigator program at a public hospital significantly improved adherence to breast cancer quality care indicators from 69% to 86% among 100 newly diagnosed patients (Stages I to III).

The program particularly enhanced the use of surveillance mammography, increasing adherence from 52% to 76%, demonstrating that patient navigators can effectively address barriers to care in uninsured populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving breast cancer quality of care with the use of patient navigators. Chen, F., Mercado, C., Yermilov, I., et al.[2010]

Breast cancer patients who received telephone-based consultations from oncology nurse navigators showed a significant increase in healthcare utilization (HCU) after their first consultation, with average annual costs rising from $8,857 to $44,130, primarily due to more outpatient visits and medication expenses.

The study found that more frequent consultations were linked to higher HCU, suggesting that proactive telemedical care may encourage patients to seek more healthcare services, which could improve their overall management of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare utilization of breast cancer patients following telephone-based consultations of oncology nurse navigator via telemedical care. Adler, G., Kaufman, G., Simon-Tuval, T.[2020]

A study involving 33 stakeholders, including patient navigators and breast cancer patients, identified key barriers in patient navigator workflows such as resource limitations, insurance issues, communication challenges, and logistical tasks that hinder effective breast cancer care.

Stakeholders emphasized the importance of user experience and specific app features in a mobile health (mHealth) app, suggesting that these elements could significantly improve patient navigators' ability to provide care to breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploration of facilitators and barriers to patient navigator core functions with breast cancer patients: Implications for the development of a human-centered mHealth app. Carr, AL., Vinod, N., Farha, P., et al.[2023]

A study assessing patient navigation programs at six Boston hospitals revealed significant variability in how these programs are structured and implemented, affecting their effectiveness in supporting breast cancer patients.

Despite all hospitals offering navigation services, inconsistencies in funding, targeted patient populations, and the continuity of services highlight critical gaps that could be addressed to improve care and reduce disparities in breast cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of patient navigation programs for breast cancer patients across the city of Boston. LeClair, AM., Battaglia, TA., Casanova, NL., et al.[2022]

A study involving 1,552 breast cancer patients (776 navigated and 776 control) found that lay navigation significantly reduced Medicare spending by $528 per quarter for older adults, particularly benefiting those with early-stage breast cancer.

Patients receiving navigation reported lower rates of hospitalizations and ER visits, highlighting the program's effectiveness in managing healthcare utilization and addressing patient distress, especially in early-stage cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare utilization, Medicare spending, and sources of patient distress identified during implementation of a lay navigation program for older patients with breast cancer. Rocque, GB., Williams, CP., Jones, MI., et al.[2018]

Cancer patient navigation (PN) programs significantly improve access to and utilization of cancer care for underserved populations, highlighting their importance in addressing healthcare disparities.

The study outlines five PN programs that perform similar tasks across the cancer care continuum, suggesting that standardized task lists can aid in developing effective navigation programs and potentially lead to certification and reimbursement for navigators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer patient navigator tasks across the cancer care continuum. Braun, KL., Kagawa-Singer, M., Holden, AE., et al.[2022]

The study analyzed patient navigator activities in 10 breast cancer navigation programs, revealing that individual-level tasks were consistently aligned with the published navigation model, emphasizing the importance of personalized support for patients.

However, there was significant variation in program-level principles, suggesting that factors like the use of volunteer versus clinical navigators influenced how closely programs adhered to the model, indicating a need for tailored guidance to meet community-specific needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of patient navigator activities in breast cancer patient navigation programs using a nine-principle framework. Gunn, CM., Clark, JA., Battaglia, TA., et al.[2021]

The implementation of a breast cancer navigation (BCN) program significantly improved the timeliness of biopsy result disclosures and initial consultations for patients, enhancing overall patient care coordination.

Patients experienced fewer outpatient visits and increased referrals to cancer specialists within a month of biopsy, indicating more efficient use of healthcare resources and better management of their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lean Practices for Resource Use, Timeliness, and Coordination of Care in Breast Cancer Navigation. Hung, DY., Kim, P., Li, M., et al.[2022]

The breast cancer nurse navigator (BCNN) program at the University of New Mexico Comprehensive Cancer Center significantly improved patient preparedness and engagement for treatment among 54 navigated patients compared to 32 non-navigated patients.

Patients who received navigation reported higher satisfaction with their care, as evidenced by a decreased desire for after-treatment summaries, suggesting that the BCNN program effectively addresses gaps in cancer care for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Measures of a Breast Cancer Nurse Navigator Program in an Underserved, Rural, and Economically Disadvantaged Patient Population. Williams, MA., Nielsen, DR., Dayao, Z., et al.[2022]

eHealth technologies can significantly enhance the management of chronic diseases, particularly in cancer care, by improving patient care and coordination among healthcare providers.

Mobile health (mHealth) tools are essential for providing timely information to both patients and caregivers, helping to monitor treatment and manage the complexities and toxicities associated with cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[eHealth and mHealth: current developments in 2014 and perspectives in oncology]. Brouard, B., Bardo, P., Vignot, M., et al.[2014]

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]

References

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

Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. [2018]

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

Improving breast cancer quality of care with the use of patient navigators. [2010]

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

Healthcare utilization of breast cancer patients following telephone-based consultations of oncology nurse navigator via telemedical care. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

An exploration of facilitators and barriers to patient navigator core functions with breast cancer patients: Implications for the development of a human-centered mHealth app. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Assessment of patient navigation programs for breast cancer patients across the city of Boston. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Healthcare utilization, Medicare spending, and sources of patient distress identified during implementation of a lay navigation program for older patients with breast cancer. [2018]

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

Cancer patient navigator tasks across the cancer care continuum. [2022]

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

An assessment of patient navigator activities in breast cancer patient navigation programs using a nine-principle framework. [2021]

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

Lean Practices for Resource Use, Timeliness, and Coordination of Care in Breast Cancer Navigation. [2022]

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

Patient-Reported Measures of a Breast Cancer Nurse Navigator Program in an Underserved, Rural, and Economically Disadvantaged Patient Population. [2022]

11. France pubmed.ncbi.nlm.nih.gov

[eHealth and mHealth: current developments in 2014 and perspectives in oncology]. [2014]

12. China pubmed.ncbi.nlm.nih.gov

Mobile health applications for the care of patients with breast cancer: A scoping review. [2022]