Mobile Health for Adherence in Breast Cancer Patients

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112613
• Other study ID #: EAQ221CD
• Secondary ID: NCI-2023-02646EA
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: July 31, 2027

Study information

• Verified date: May 2024
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma

Intervention

Other:
• Electronic Health Record Review
Ancillary studies
• Health Promotion and Education
Receive access to educational materials

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:
• 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

Locations

Country	Name	City	State
United States	Saint Anthony's Health	Alton	Illinois
United States	Mary Greeley Medical Center	Ames	Iowa
United States	McFarland Clinic - Ames	Ames	Iowa
United States	Community Hospital of Anaconda	Anaconda	Montana
United States	ThedaCare Regional Cancer Center	Appleton	Wisconsin
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia
United States	Rush - Copley Medical Center	Aurora	Illinois
United States	Saint Alphonsus Medical Center-Baker City	Baker City	Oregon
United States	Saint Louis Cancer and Breast Institute-Ballwin	Ballwin	Missouri
United States	ThedaCare Cancer Care - Berlin	Berlin	Wisconsin
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho
United States	Central Care Cancer Center - Bolivar	Bolivar	Missouri
United States	McFarland Clinic - Boone	Boone	Iowa
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Cox Cancer Center Branson	Branson	Missouri
United States	Minnesota Oncology - Burnsville	Burnsville	Minnesota
United States	Saint Alphonsus Cancer Care Center-Caldwell	Caldwell	Idaho
United States	Cambridge Medical Center	Cambridge	Minnesota
United States	Mercy Hospital	Cedar Rapids	Iowa
United States	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa
United States	Saint Mary's Hospital	Centralia	Illinois
United States	Billings Clinic-Cody	Cody	Wyoming
United States	Kootenai Health - Coeur d'Alene	Coeur d'Alene	Idaho
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Carle at The Riverfront	Danville	Illinois
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Carle Physician Group-Effingham	Effingham	Illinois
United States	Walter Knox Memorial Hospital	Emmett	Idaho
United States	McFarland Clinic - Trinity Cancer Center	Fort Dodge	Iowa
United States	Mercy Hospital Fort Smith	Fort Smith	Arkansas
United States	Central Care Cancer Center - Garden City	Garden City	Kansas
United States	Central Care Cancer Center - Great Bend	Great Bend	Kansas
United States	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana
United States	Great Falls Clinic	Great Falls	Montana
United States	McFarland Clinic - Jefferson	Jefferson	Iowa
United States	Freeman Health System	Joplin	Missouri
United States	Mercy Hospital Joplin	Joplin	Missouri
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	CARTI Cancer Center	Little Rock	Arkansas
United States	Fairview Clinics and Surgery Center Maple Grove	Maple Grove	Minnesota
United States	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	McFarland Clinic - Marshalltown	Marshalltown	Iowa
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Idaho Urologic Institute-Meridian	Meridian	Idaho
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Health Partners Inc	Minneapolis	Minnesota
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Community Medical Hospital	Missoula	Montana
United States	Monticello Cancer Center	Monticello	Minnesota
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Saint Alphonsus Cancer Care Center-Nampa	Nampa	Idaho
United States	ThedaCare Regional Medical Center - Neenah	Neenah	Wisconsin
United States	ThedaCare Cancer Care - New London	New London	Wisconsin
United States	Cancer Center of Western Wisconsin	New Richmond	Wisconsin
United States	New Ulm Medical Center	New Ulm	Minnesota
United States	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma
United States	Saint Alphonsus Medical Center-Ontario	Ontario	Oregon
United States	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California
United States	Lake Regional Hospital	Osage Beach	Missouri
United States	ThedaCare Cancer Care - Oshkosh	Oshkosh	Wisconsin
United States	Kootenai Clinic Cancer Services - Post Falls	Post Falls	Idaho
United States	Fairview Northland Medical Center	Princeton	Minnesota
United States	North Memorial Medical Health Center	Robbinsdale	Minnesota
United States	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri
United States	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Mercy Hospital South	Saint Louis	Missouri
United States	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Kootenai Cancer Clinic	Sandpoint	Idaho
United States	Saint Francis Regional Medical Center	Shakopee	Minnesota
United States	ThedaCare Cancer Care - Shawano	Shawano	Wisconsin
United States	Welch Cancer Center	Sheridan	Wyoming
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Lakeview Hospital	Stillwater	Minnesota
United States	Carle Cancer Center	Urbana	Illinois
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Mercy Hospital Washington	Washington	Missouri
United States	ThedaCare Cancer Care - Waupaca	Waupaca	Wisconsin
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota
United States	Fairview Lakes Medical Center	Wyoming	Minnesota
United States	Rush-Copley Healthcare Center	Yorkville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Longitudinal changes of patient-reported outcomes	Generalized estimating equation will be used to assess the longitudinal change over time.	At baseline, 3, 6 and 12 months
Other	Healthcare utilization	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.	At baseline, 3, 6, and12 months
Other	Progression-free survival	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.	At 3 and 12 months
Other	Overall survival	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.	At 3 and 12 months
Other	CONCURxP arm patients and their provider experience	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.	Up to 12 months
Other	Characteristics of National Cancer Institute Community Oncology Research Program (NCORP) site patient population and the enrollees in EAQ221CD.	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.	Up to 12 months
Primary	Adherence using electronic monitoring	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.	At 12 months after initiation of medication
Secondary	Adherence using self-report	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.	At 3, 6, and 12 months
Secondary	CDK4/6i persistence	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.	At 12 months after initiation of medication
Secondary	Symptom burden	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.	At baseline, 3, 6 and 12 months
Secondary	Quality of life	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.	At baseline and 12 months
Secondary	Patient-provider communication	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.	At baseline, 3, 6, and 12 months
Secondary	Self-efficacy for managing symptoms	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.	At baseline, 3, 6, and12 months
Secondary	Financial worry	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.	At baseline, 3, 6, and12 months