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Mobile Health for Adherence in Breast Cancer Patients

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06112613
Enrollment
410
Registered
2023-11-01
Start date
2024-01-26
Completion date
2027-07-31
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma

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 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

OTHERElectronic Health Record Review

Ancillary studies

OTHERHealth Promotion and Education

Receive access to educational materials

Utilize the WiseBag medication dispenser

OTHERInterview

Complete an interview

BEHAVIORALPatient Navigation

Receive healthcare provider follow ups as part of the CONCURxP program

OTHERSurvey Administration

Ancillary studies

Receive personalized text message reminders related to their medication tracking as part of the CONCURxP program

Sponsors

ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence using electronic monitoringAt 12 months after initiation of medicationFor 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

MeasureTime frameDescription
Adherence using self-reportAt 3, 6, and 12 monthsUsing 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 persistenceAt 12 months after initiation of medicationDefined as duration from CDK4/6i initiation to discontinuation of medication against medical advice, measured as the number of days from initiation 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 burdenAt baseline, 3, 6 and 12 monthsUsing 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 lifeAt baseline and 12 monthsUsing 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.
Patient-provider communicationAt baseline, 3, 6, and 12 monthsUsing 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.
Self-efficacy for managing symptomsAt baseline, 3, 6, and12 monthsUsing 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.
Financial worryAt baseline, 3, 6, and12 monthsUsing 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.

Countries

Puerto Rico, United States

Contacts

PRINCIPAL_INVESTIGATORGelareh Sadigh

ECOG-ACRIN Cancer Research Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026