Mobile Health for Breast Cancer
Recruiting in Palo Alto (17 mi)
+387 other locations
Overseen ByGelareh Sadigh
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: ECOG-ACRIN Cancer Research Group
No Placebo Group
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.
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.
48101112Is 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.
236912What 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%.
157912Will 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.
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.
I am 18 years old or older.
My breast cancer is hormone receptor positive and HER2 negative.
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: ARM C (Non-patient interview)Experimental Treatment1 Intervention
Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment.
Group II: ARM B (CONCURxP program)Experimental Treatment6 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 Treatment4 Interventions
Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Fairbanks Memorial HospitalFairbanks, AK
Kingman Regional Medical CenterKingman, AZ
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, AR
Kaiser Permanente-AnaheimAnaheim, CA
More Trial Locations
Loading ...
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Improving breast cancer quality of care with the use of patient navigators. [2010]The continuum of breast cancer care requires multidisciplinary efforts. Patient navigators, who perform outreach, coordination, and education, have been shown to improve some areas of care. However, little research has assessed the impact of navigators on breast cancer treatment in uninsured populations. Our objective is to report on the impact of a patient navigator program on breast cancer quality of care at a public hospital. One hundred consecutive newly diagnosed patients with breast cancer (Stages I to III) were identified (2005 to 2007). Forty-nine patients were treated before the use of navigators and 51 after program implementation. Nine breast cancer quality indicators were used to evaluate quality of care. Overall adherence to the quality indicators improved from 69 to 86 per cent with the use of patient navigators (P
Cancer patient navigator tasks across the cancer care continuum. [2022]Cancer patient navigation (PN) programs have been shown to increase access to and utilization of cancer care for poor and underserved individuals. Despite mounting evidence of its value, cancer patient navigation is not universally understood or provided. We describe five PN programs and the range of tasks their navigators provide across the cancer care continuum (education and outreach, screening, diagnosis and staging, treatment, survivorship, and end-of-life). Tasks are organized by their potential to make cancer services understandable, available, accessible, affordable, appropriate, and accountable. Although navigators perform similar tasks across the five programs, their specific approaches reflect differences in community culture, context, program setting, and funding. Task lists can inform the development of programs, job descriptions, training, and evaluation. They also may be useful in the move to certify navigators and establish mechanisms for reimbursement for navigation services.
An assessment of patient navigator activities in breast cancer patient navigation programs using a nine-principle framework. [2021]To determine how closely a published model of navigation reflects the practice of navigation in breast cancer patient navigation programs.
[eHealth and mHealth: current developments in 2014 and perspectives in oncology]. [2014]New information technologies and communication in health or "eHealth" is a way of improvement for management of chronic diseases. EHealth can improve patient care and care coordination especially in cancer patients who require a multidisciplinary approach. Treatments in oncology are complex and can result in new toxicities. Information of patients and of caregivers is a crucial issue. The patients require to be monitored and the caregivers need up-to-date information. The mobile component of eHealth: the mobile health or "mHealth" could provide to this need. This paper proposes to expose the principles of eHealth and its mobile component mHealth then to discuss their place in the management of cancer, for patients and caregivers.
Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. [2018]Patient navigation (PN) can improve breast cancer care among disadvantaged women. We evaluated the impact of a PN program on follow-up after an abnormal mammogram.
Healthcare utilization, Medicare spending, and sources of patient distress identified during implementation of a lay navigation program for older patients with breast cancer. [2018]Despite benefits for patients, sustainability of breast cancer navigation programs is challenging due to the lack of reimbursement for navigators. This analysis describes distress reported by breast cancer patients to navigators and the impact of navigation on healthcare utilization for older adults with breast cancer.
Healthcare utilization of breast cancer patients following telephone-based consultations of oncology nurse navigator via telemedical care. [2020]To characterize breast cancer patients who received telephone-based consultations of oncology nurse navigator via telemedical care (TMC patients) and analyze their healthcare utilization (HCU) one year before and after receiving this service.
Mobile health applications for the care of patients with breast cancer: A scoping review. [2022]In recent years, the use of mobile health applications (mHealth apps) to deliver care for patients with breast cancer has increased exponentially. This study aimed to summarize the available evidence on developing mHealth apps to care for patients with breast cancer and identify the need for systematic efforts.
Assessment of patient navigation programs for breast cancer patients across the city of Boston. [2022]Healthcare systems contribute to disparities in breast cancer outcomes. Patient navigation is a widely cited system-based approach to improve outcomes among populations at risk for delays in care. Patient navigation programs exist in all major Boston hospitals, yet disparities in outcomes persist. The objective of this study was to conduct a baseline assessment of navigation processes at six Boston hospitals that provide breast cancer care in preparation for an implementation trial of standardized navigation across the city.
Lean Practices for Resource Use, Timeliness, and Coordination of Care in Breast Cancer Navigation. [2022]Cancer care is described as insufficiently patient-centered, requiring improved accessibility and coordination. Breast oncology nurse navigators may help provide timely patient care by improving care coordination.
Patient-Reported Measures of a Breast Cancer Nurse Navigator Program in an Underserved, Rural, and Economically Disadvantaged Patient Population. [2022]To assess the efficacy of the University of New Mexico Comprehensive Cancer Center's (UNMCCC's) breast cancer nurse navigator (BCNN) program in addressing gaps in cancer care for an underserved, rural, and economically disadvantaged population.
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]To understand the barriers to core functions and workflow among patient navigators (PN) who navigate people diagnosed with breast cancer (BC). To identify how a mobile health (mHealth) app could assist PNs in providing care to BC patients.