Breast Carcinoma
Conditions
Brief 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 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 breast cancer who are taking a CKD4/6 inhibitor.
Detailed description
PRIMARY OBJECTIVE: I. To compare CDK4/6 inhibitors (CDK4/6i) adherence at 12 months after randomization captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms. SECONDARY OBJECTIVES: I. To compare CDK4/6i adherence at 12 months after randomization captured through self-report between the EUC (Arm A) and CONCURxP (Arm B) arms. II. To compare CDK4/6i persistence at 12 months after randomization captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms. III. To compare symptom burden at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. IV. To compare quality of life at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. V. To compare patient-provider communication at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. VI. To compare self-efficacy for managing symptoms at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. VII. To compare financial worry at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. EXPLORATORY OBJECTIVES: I. To assess longitudinal changes of patient-reported outcomes (self reported adherence, symptom burden, quality of life, and financial worry) from randomization to 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. II. To compare healthcare utilization at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. III. To describe CONCURxP (Arm B) patients experience with various implementation outcomes. OUTLINE: Patients are randomized into 1 of 2 arms. ARM A: Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months. ARM B: 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. After completion of study intervention, patients may be followed up to 6 months.
Interventions
Ancillary studies
Receive access to educational materials
Utilize the WiseBag medication dispenser
Receive healthcare provider follow ups as part of the CONCURxP program
Ancillary studies
Receive personalized text message reminders related to their medication tracking as part of the CONCURxP program
Sponsors
Study design
Eligibility
Inclusion criteria
* 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 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 60 days prior to registration to Step 0 or have received a prescription order with stated intent to initiate within 30 days following registration to Step 0 * 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 supplied as capsules in a pill bottle (e.g., Ibrance capsules), patient is not eligible * NOTE: Ribociclib (Kisqali) and abemaciclib (Verzenio) are only available in blister packs. Palbociclib (Ibrance) is the only CDK4/6 inhibitor that might be available in a capsule formulation. However, this is an outdated formulation and is rarely prescribed as a new start. The format of ordered palbociclib can be determined based on the prescription order * PATIENT STEP 0: Patient must not have been previously treated with any of the following CDK4/6 inhibitors: Palbociclib or Ibrance, ribociclib or Kisqali, and abemaciclib or Verzenio * PATIENT STEP 0: Patient must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors * PATIENT STEP 0: Patient must not be enrolled in a symptom science clinical trial that monitors or intervenes on symptoms related to CDK4/6 inhibitors * NOTE: If NRG-CC012CD is activated in a participating practice, and a patient meets the eligibility criteria for both EAQ221CD and NRG-CC012CD, then EAQ221CD should be offered first to patients. Only if a patient is not eligible or not interested in participating in EAQ221CD, the NRG-CC012CD can be offered * PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at a National Cancer Institute Community Oncology Research Program (NCORP) site or one of the following two NCI designated Comprehensive Cancer Centers: Emory University Winship Cancer Institute or University of California Irvine Chao Family Comprehensive Cancer Center * PATIENT STEP 0: Patient must have either a personal smartphone in which they agree to receive text messages or an email address in addition to a non-smart mobile phone in which they agree to receive text messages * NOTE: Since mobile phones that are not smart phones cannot follow web links in a text message, people with non-smart mobile phones will also need an email address * PATIENT STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document * NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible * PATIENT STEP 0: Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status \>= 3 OR patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice) * PATIENT STEP 0: Patient must not be enrolled in other trials offering financial assistance * NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance * PATIENT STEP 1: Patient must meet all the eligibility criteria for step 0 * PATIENT STEP 1: Patient must have signed a written informed consent form * PATIENT STEP 1: Patient must have completed baseline survey within 30 days after Oncology Patient Enrollment Network (OPEN) screening registration (step 0) * PATIENT STEP 1: Patients must have initiated their CDK 4/6 inhibitors either 60 days prior to or 30 days after the date of OPEN Screening Registration (Step 0) * PATIENT STEP 1: Step 1 registration must occur within 45 days of Step 0 registration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence using electronic monitoring | At 12 months after randomization | For each arm, mean and standard deviation (SD) adherence rates for all patients will be calculated. A two-sample t-test will be used to compare CDK4/6 inhibitor (CDK4/6i) adherence between the two arms at 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Financial worry | At 12 months after randomization | Using the Comprehensive Score for Financial Toxicity compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests. |
| Adherence using self-report | At 12 months after randomization | Using the12-item Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests. |
| CDK4/6i persistence | At 12 months after randomization | Defined as duration from randomization to discontinuation of medication against medical advice, measured as the number of days from randomization until the first day of a gap that is 30 days or longer. For each arm, mean days of persistence, and the proportion of patients who discontinue the medication earlier than 12-month will be calculated and compared between the two arms using the two-sample t-test and chi-squared test, respectively. |
| Symptom burden | At 12 months after randomization | Using the 16-item National-Comprehensive Cancer Network Functional Assessment of Cancer Therapy Breast Cancer Symptom index compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests. |
| Quality of life | At 12 months after randomization | Using the PROMIS-10- version (v)1.2-Global Health compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests. |
| Self-efficacy for managing symptoms | At 12 months after randomization | Using PROMIS Item Bank v1.0 - Self-Efficacy for Managing Symptoms compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests. |
| Patient-provider communication | At 12 months after randomization | Using the Consumer Assessment of Healthcare Providers and Systems compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests. |
Countries
Puerto Rico, United States
Contacts
ECOG-ACRIN Cancer Research Group