Status:
RECRUITING
Mobile Health for Adherence in Breast Cancer Patients
Lead Sponsor:
ECOG-ACRIN Cancer Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anatomic Stage IV Breast Cancer AJCC v8
Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 (...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT06112613
Start Date
January 26 2024
End Date
July 31 2027
Last Update
December 30 2025
Active Locations (400)
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1
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
2
Kingman Regional Medical Center
Kingman, Arizona, United States, 86401
3
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
4
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States, 72903