Mobile Health for Breast Cancer

Recruiting at 396 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a tool called WiseBag, alone or with a program called CONCURxP, can help individuals with metastatic breast cancer remember to take their medication on time. The researchers aim to determine if these methods, along with Patient Navigation (a healthcare support service), can improve adherence to CDK4/6 inhibitors, which are crucial cancer drugs. This study may suit those who have recently started these medications and can receive text message reminders. Participants must have metastatic breast cancer that is hormone receptor-positive and HER2-negative and be able to use text messaging and email. As an unphased trial, this study offers a unique opportunity to explore innovative ways to support medication adherence.

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 prior data suggests that the WiseBag and CONCURxP platform are safe for monitoring medication adherence in patients with metastatic breast cancer?

Research has shown that patient navigation, which helps individuals overcome challenges in their healthcare, is generally safe and well-received. Studies have found that these programs effectively support individuals with cancer by facilitating access to necessary screenings and treatments without causing harmful effects. This method is widely used to ensure patients receive timely care and support. No major safety concerns exist with patient navigation, as it primarily involves providing guidance and support rather than medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support breast cancer patients beyond standard treatments like surgery, chemotherapy, and radiation. The trial focuses on using mobile health technology to enhance patient care. In ARM A, patients benefit from the WiseBag medication dispenser and educational materials, potentially improving adherence and understanding. ARM B takes it further with the CONCURxP program, which adds personalized text reminders and healthcare provider follow-ups, aiming to keep patients engaged and on track with their treatment. This trial could reveal how technology-driven patient navigation can make a difference in managing breast cancer care.

What evidence suggests that this trial's treatments could be effective for improving medication adherence in metastatic breast cancer patients?

This trial will evaluate different approaches to support breast cancer patients in adhering to their medication regimens. Participants in ARM B will use the WiseBag with the CONCURxP program, which includes personalized text message reminders, medication tracking, and healthcare provider follow-ups. Research has shown that the WiseBag with the CONCURxP program can help breast cancer patients take their medication on time. This is especially important for those using CDK4/6 inhibitors, which must be taken exactly as prescribed to be effective. Studies indicate that forgetfulness is a common reason patients miss doses. Tools like text reminders and medication tracking can help patients remember to take their pills. Meanwhile, participants in ARM A will use the WiseBag and receive educational materials every 4 weeks. The WiseBag also provides educational materials, which can assist patients in adhering to their treatment plans. Both methods aim to improve patient adherence to prescribed treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Gelareh Sadigh

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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.

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

You are an oncology healthcare professional, such as a physician, nurse practitioner or nurse.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. ecog-acrin.org ecog-acrin.org/clinical-trials/eaq221cd-concurxp-breast-cancer/

EAQ221CD / CONCURxP Home Page Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with breast cancer who are taking a CKD4/6 inhibitor.

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-02646

Mobile Health for Adherence in Breast Cancer Patients - NCI Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with breast cancer who are taking a CKD4/6 inhibitor.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06112613

Mobile Health for Adherence in Breast Cancer Patients This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called ...

4. trialx.com trialx.com/clinical-trials/listings/223186/mobile-health-for-adherence-in-breast-cancer-patients/

Mobile Health for Adherence in Breast Cancer Patients This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring ...

5. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT06112613

Mobile Health for Adherence in Breast Cancer Patients This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called ...

6. cdc.gov cdc.gov/cancer/php/interventions/patient-navigation.html

Patient Navigation | Cancer Patient navigators work with people, their families, and their caregivers to overcome barriers to cancer screening and diagnosis, cancer care, and resources ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8462600/

Systematic Patient Navigation Strategies to Scale Breast ... Patient navigation uses trained personnel to eliminate barriers to timely care across all phases of the health care continuum, thereby reducing health ...

8. ascopubs.org ascopubs.org/doi/10.1200/jco.2009.27.15_suppl.6572

Impact of patient navigation on breast cancer outcomes One potential impact of PN program was dramatic increase in proportion of insured patients. Overall survival was not influenced by the PN program. Conclusions: ...

9. womenspreventivehealth.org womenspreventivehealth.org/wp-content/uploads/Patient-Navigation-Evidence-Review-Nov-25-2024.pdf

Patient Navigation Services for Breast and Cervical Cancer ... Patient navigation services are provided by healthcare systems to help patients overcome barriers to cancer screening and follow-up as they move ...

10. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Patient navigation is a strategy for overcoming barriers to reduce disparities and to improve access and outcomes. The aim of this umbrella ...