Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ARM A (Enhanced usual care)
Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months.
  • 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: Survey Administration
    Ancillary studies
Experimental
ARM B (CONCURxP program)
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.
  • Other: Electronic Health Record Review
    Ancillary studies
  • 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 names:
    • Patient Navigator 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
    Other names:
    • Automated Text Message-Based Navigation
    • Text Message-Based Navigation
Experimental
ARM C (Non-patient interview)
Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment.
  • Other: Interview
    Complete an interview

Recruiting Locations

MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
Contact:
Site Public Contact
202-444-2223

More Details

Status
Recruiting
Sponsor
ECOG-ACRIN Cancer Research Group

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.