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 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 breast cancer who are taking a CKD4/6 inhibitor.
Brief Title
Mobile Health for Adherence in Breast Cancer Patients
Detailed Description
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
BREAST CARCINOMA
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06112613
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
EAQ221CD
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Improving Medication Adherence in Breast Cancer Using a CONnected CUstomized Treatment Platform (CONCURxP)
Primary Outcomes
Outcome Description
For 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.
Outcome Measure
Adherence using electronic monitoring
Outcome Time Frame
At 12 months after randomization
Secondary Ids
Secondary Id
NCI-2023-02646
Secondary Id
EAQ221CD
Secondary Id
ECOG-ACRIN-EAQ221CD
Secondary Id
EAQ221CD
Secondary Id
R01CA262312
Secondary Id
UG1CA189828
Secondary Outcomes
Outcome Description
Using 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.
Outcome Time Frame
At 12 months after randomization
Outcome Measure
Adherence using self-report
Outcome Description
Defined as duration from randomization to discontinuation of medication against medical advice, measured as the number of days from randomization 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.
Outcome Time Frame
At 12 months after randomization
Outcome Measure
CDK4/6i persistence
Outcome Description
Using 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.
Outcome Time Frame
At 12 months after randomization
Outcome Measure
Symptom burden
Outcome Description
Using 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.
Outcome Time Frame
At 12 months after randomization
Outcome Measure
Quality of life
Outcome Description
Using 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.
Outcome Time Frame
At 12 months after randomization
Outcome Measure
Patient-provider communication
Outcome Description
Using 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.
Outcome Time Frame
At 12 months after randomization
Outcome Measure
Self-efficacy for managing symptoms
Outcome Description
Using 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.
Outcome Time Frame
At 12 months after randomization
Outcome Measure
Financial worry
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Della Makower
Investigator Email
DMAKOWER@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Breast Cancer --- BREAST NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
MeSH Terms
BREAST NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
BREAST DISEASES
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
HEALTH PROMOTION
EDUCATIONAL STATUS
PATIENT NAVIGATION
HEALTH EDUCATION
PREVENTIVE HEALTH SERVICES
HEALTH SERVICES
HEALTH CARE FACILITIES WORKFORCE AND SERVICES
SOCIOECONOMIC FACTORS
POPULATION CHARACTERISTICS
PATIENT-CENTERED CARE
PRIMARY HEALTH CARE
COMPREHENSIVE HEALTH CARE
PATIENT CARE MANAGEMENT
HEALTH SERVICES ADMINISTRATION