History of Changes for Study: NCT06112613

Version	Submitted Date	Changes
1	October 27, 2023	None (earliest Version on record)
2	December 14, 2023	Recruitment Status, Study Status, Arms and Interventions, Study Description, Contacts/Locations, Eligibility, Outcome Measures and Sponsor/Collaborators
3	April 9, 2024	Study Status and Sponsor/Collaborators

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.

Arms

Assigned Interventions

Experimental: ARM A (Enhanced usual care)

Patients use the Wisebag medication dispenser and receive access to educational materials every 4 weeks over 12 months.

Electronic Health Record Review

Ancillary studies

Health Promotion and Education

Receive access to educational materials

Procedure: Health Telemonitoring

Utilize the Wisebag medication dispenser

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.

Electronic Health Record Review

Ancillary studies

Procedure: Health Telemonitoring

Utilize the Wisebag medication dispenser

Interview

Complete an interview

Behavioral: Patient Navigation

Receive healthcare provider follow ups as part of the CONCURxP program

Other Names:

Patient Navigator Program

Survey Administration

Ancillary studies

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.

Interview

Complete an interview

Outcome Measures


Primary Outcome Measures:
1.	Adherence using electronic monitoring [ Time Frame: At 12 months after initiation of medication ] 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.
Secondary Outcome Measures:
1.	Adherence using self-report [ Time Frame: At 3, 6, and 12 months ] 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.
2.	CDK4/6i persistence [ Time Frame: At 12 months after initiation of medication ] Defined 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.
3.	Symptom burden [ Time Frame: At baseline, 3, 6 and 12 months ] Using the 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.
4.	Quality of life [ Time Frame: At baseline and 12 months ] 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.
5.	Patient-provider communication [ Time Frame: At baseline, 3, 6, and 12 months ] 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.
6.	Self-efficacy for managing symptoms [ Time Frame: At baseline, 3, 6, and12 months ] 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.
7.	Financial worry [ Time Frame: At baseline, 3, 6, and12 months ] 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.
Other Outcome Measures:
1.	Longitudinal changes of patient-reported outcomes [ Time Frame: At baseline, 3, 6 and 12 months ] Generalized estimating equation will be used to assess the longitudinal change over time.
2.	Healthcare utilization [ Time Frame: At baseline, 3, 6, and12 months ] The difference of healthcare utilization between two arms will first be evaluated using the two sample t test for the continuous variables (e.g., length of stay or number of emergency department visits), and then be modeled through the regressions to allow for the control of other covariates if needed.
3.	Progression-free survival [ Time Frame: At 3 and 12 months ] Kaplan-Meier curves and log-rank testing will be used to visualize and compare progression free survival between the connected customized treatment platform (CONCURxP) patient group and enhanced usual care group, and Cox proportional hazards model will be fit to evaluate the impact of potential moderators on the associations of progression-free survival with arms.
4.	Overall survival [ Time Frame: At 3 and 12 months ] Kaplan-Meier curves and log-rank testing will be used to visualize and compare overall survival between the CONCURxP patient group and enhanced usual care group, and Cox proportional hazards model will be fit to evaluate the impact of potential moderators on the associations of overall survival with arms.
5.	CONCURxP arm patients and their provider experience [ Time Frame: Up to 12 months ] We will measure portal usability using patient-reported survey and will report mean and SD. For qualitative interviews, we will use conventional content analysis methods.
6.	Characteristics of National Cancer Institute Community Oncology Research Program (NCORP) site patient population and the enrollees in EAQ221CD. [ Time Frame: Up to 12 months ] Cox proportional hazards model will be fit to evaluate the impact of potential moderators (e.g., sociodemographic, insurance, cancer variables, endocrine therapy adherence, health literacy, health belief, medical history and NCORP practice characteristics.

Minimum Age:

18 Years

Maximum Age:

Sex:

All

Gender Based:

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 (Kisgali) 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