Mobile Health for Adherence in Breast Cancer Patients (NCT06112613) | Clinical Trial Compass
RecruitingNot Applicable
Mobile Health for Adherence in Breast Cancer Patients
United States, Puerto Rico410 participantsStarted 2024-01-26
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* NON-PATIENT: Participants must be an oncology healthcare provider (i.e., oncologist, advanced practice provider, or oncology nurse)
* NON-PATIENT: Participants must have taken care of at least one patient randomized to Arm B (CONCURxP) who had less than 85% adherence rate at 12 months as measured by the WiseBag
* NON-PATIENT: Participant must speak English
* NON-PATIENT: Participant must be employed at an National Cancer Institute Community Oncology Research Program (NCORP) site for at least 6 months
* NON-PATIENT: Participant must be able to provide informed consent to participate in this study
* PATIENT STEP 0: Patient must be \>= 18 years of age
* PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish
* PATIENT STEP 0: Patient must present with new or established pathologically proven hormone receptor (HR)+ HER2- metastatic breast cancer at the time of Step 0
* PATIENT STEP 0: Patient must have initiated any of the CKD4/6 inhibitors (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) within 30 days prior to consenting to Step 0 or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent
* NOTE: Patients who have been treated previously with anticancer treatments other than CDK4/6 inhibitors are eligible
* NOTE: CDK4/6 inhibitors must be provided/supplied as a single agent blister pack. If the medication is s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on tracking whether I take my medications correctly using electronic monitoring — does that mean it's studying my behavior around adherence rather than testing a new drug, and how would that affect my current hormone therapy treatment plan?
2Since this trial is for stage IV hormone receptor-positive, HER2-negative breast cancer, can you help me understand whether joining would change anything about the actual medications I'd be taking, or would I continue on whatever treatment you'd already recommend for me?
3What does the electronic monitoring for adherence actually involve day-to-day — like a special pill bottle, an app, or check-ins — and is that something that would realistically fit into my life right now given everything else I'm managing?
4This trial is listed as 'Phase NA,' which suggests it's more of a behavioral or observational study than a drug trial — does that mean the safety risks of participating are lower, and are there any risks I should still be aware of?
5If I'm already struggling with remembering to take my medications or dealing with side effects that make adherence hard, is this trial designed to help with that, or is it mainly collecting data, and either way, would you recommend it for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence using electronic monitoring
Timeframe: At 12 months after initiation of medication