Mobile Health for Adherence in Breast Cancer Patients

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.

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