Mobile Health for Adherence in Breast Cancer Patients

Official title

Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Overview

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.

Detailed description

PRIMARY OBJECTIVE:

I. To compare CDK4/6 inhibitors (CDK4/6i) adherence at 12 months after completion of the baseline survey 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 completion of the baseline survey captured through self-report between the EUC (Arm A) and CONCURxP (Arm B) arms.

II. To compare CDK4/6i persistence at 12 months after completion of the baseline survey captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms.

III. To compare symptom burden at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

IV. To compare quality of life at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

V. To compare patient-provider communication at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

VI. To compare self-efficacy for managing symptoms at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

VII. To compare financial worry at 12 months 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 the EUC (Arm A) and CONCURxP (Arm B) arms.

II. To compare healthcare utilization at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

III. To compare progression-free survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

IV. To compare overall survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

V. To describe CONCURxP (Arm B) patients and their provider experience with various implementation outcomes.

OUTLINE: Patients are randomized into 1 of 2 arms. Non-patient participants are assigned to arm C.

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.

ARM C: Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment.

After completion of study intervention, patients may be followed up to 6 months.

Interventions

• Other Electronic Health Record Review
  Ancillary studies
• Other Health Promotion and Education
  Receive access to educational materials
• Procedure Health Telemonitoring
  Utilize the WiseBag medication dispenser
• Other Interview
  Complete an interview
• Behavioral Patient Navigation
  Receive healthcare provider follow ups as part of the CONCURxP program
• Other Survey Administration
  Ancillary studies
• Other Text Message-Based Navigation Intervention
  Receive personalized text message reminders related to their medication tracking as part of the CONCURxP program

Primary outcome measures

• Adherence using electronic monitoring [Time frame: At 12 months after initiation of medication]

Secondary outcome measures (7)

• Adherence using self-report [Time frame: At 3, 6, and 12 months]
• CDK4/6i persistence [Time frame: At 12 months after initiation of medication]
• Symptom burden [Time frame: At baseline, 3, 6 and 12 months]
• Quality of life [Time frame: At baseline and 12 months]
• Patient-provider communication [Time frame: At baseline, 3, 6, and 12 months]
• Self-efficacy for managing symptoms [Time frame: At baseline, 3, 6, and12 months]
• Financial worry [Time frame: At baseline, 3, 6, and12 months]

Eligibility criteria

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 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: Patients 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: Patients must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors
• PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at an NCORP site
• PATIENT STEP 0: Patient must have a personal mobile phone in which they are able and willing to send and receive text messages

• NOTE: The restriction to those with mobile phone access with text messaging is based on the primary intention of the study which involves the use of text messaging to improve adherence
• PATIENT STEP 0: Patient must have an email address

• NOTE: The restriction to those with an email address is based on the primary intention of the study which involves patients responding to questions regarding their reasons for non-adherence after every missed dose to improve adherence
• 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 of the date of Step 0 Registration
• PATIENT STEP 1: Patients must have initiated their CDK 4/6 inhibitors within 30 days of the date of Step 0 registration

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 499 centers

• Fairbanks Memorial Hospital — Fairbanks
• Kingman Regional Medical Center — Kingman
• Cancer Center at Saint Joseph's — Phoenix
• Mercy Hospital Fort Smith — Fort Smith
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro
• CARTI Cancer Center — Little Rock
• Kaiser Permanente-Anaheim — Anaheim
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande
• … and 491 more centers

Puerto Rico · 7 centers

Center list to be confirmed — check the primary protocol.

Publications

• Sadigh G, Duan F, Gareen IF, Hancock J, Sicks JD, Thangarajah M, Meisel JL, Torres MA, Ramsey SD, Wolff AC, Wagner LI, Carlos RC, Graetz I. Improving CDK4/6 inhibitors adherence in breast cancer using the CONnected CUstomized Treatment Platform (CONCURxP) mobile health intervention: Study protocol for ECOG-ACRIN EAQ221CD. Contemp Clin Trials. 2026 Jan;160:108145. doi: 10.1016/j.cct.2025.108145. Ep PMID 41265834

Identifiers

NCT: NCT06112613 · EAQ221CD · NCI-2023-02646 · EAQ221CD · ECOG-ACRIN-EAQ221CD · EAQ221CD · R01CA262312 · UG1CA189828

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗