Mobile Health for Adherence in Breast Cancer Patients

April 9, 2024 updated by: ECOG-ACRIN Cancer Research Group

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

410

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Gelareh Sadigh
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Ilana Graetz
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Emmett, Idaho, United States, 83617
        • Recruiting
        • Walter Knox Memorial Hospital
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Idaho Urologic Institute-Meridian
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Cancer Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • Saint Anthony's Health
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Saint Mary's Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • Good Samaritan Regional Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-242-4600
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Boone, Iowa, United States, 50036
        • Recruiting
        • McFarland Clinic - Boone
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 319-365-4673
        • Principal Investigator:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Oncology Associates at Mercy Medical Center
        • Principal Investigator:
          • Deborah W. Wilbur
        • Contact:
          • Site Public Contact
          • Phone Number: 319-363-2690
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Recruiting
        • McFarland Clinic - Jefferson
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Cambridge, Minnesota, United States, 55008
        • Suspended
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Saint Louis Cancer and Breast Institute-Ballwin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7058
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Delbert Day Cancer Institute at PCRMC
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63109
        • Recruiting
        • Saint Louis Cancer and Breast Institute-South City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-353-1870
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Great Falls Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Suspended
        • Community Medical Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Recruiting
        • Saint Alphonsus Medical Center-Baker City
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Medical Center-Ontario
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Charissa K. Williams
      • Berlin, Wisconsin, United States, 54923
        • Recruiting
        • ThedaCare Cancer Care - Berlin
        • Contact:
        • Principal Investigator:
          • Charissa K. Williams
      • Neenah, Wisconsin, United States, 54956
        • Recruiting
        • ThedaCare Regional Medical Center - Neenah
        • Contact:
        • Principal Investigator:
          • Charissa K. Williams
      • New London, Wisconsin, United States, 54961
        • Recruiting
        • ThedaCare Cancer Care - New London
        • Contact:
        • Principal Investigator:
          • Charissa K. Williams
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Principal Investigator:
          • Pamala A. Pawloski
        • Contact:
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • ThedaCare Cancer Care - Oshkosh
        • Contact:
        • Principal Investigator:
          • Charissa K. Williams
      • Shawano, Wisconsin, United States, 54166
        • Recruiting
        • ThedaCare Cancer Care - Shawano
        • Contact:
        • Principal Investigator:
          • Charissa K. Williams
      • Waupaca, Wisconsin, United States, 54981
        • Recruiting
        • ThedaCare Cancer Care - Waupaca
        • Contact:
        • Principal Investigator:
          • Charissa K. Williams
    • Wyoming
      • Cody, Wyoming, United States, 82414
        • Recruiting
        • Billings Clinic-Cody
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sheridan, Wyoming, United States, 82801
        • Recruiting
        • Welch Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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: Survey Administration
Ancillary studies
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
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: Survey Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
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: 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
Procedure: Health Telemonitoring
Utilize the WiseBag medication dispenser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 months after initiation of medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 3, 6, and 12 months
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.
At 12 months after initiation of medication
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.
At baseline and 12 months
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.
At baseline, 3, 6, and 12 months
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.
At baseline, 3, 6, and12 months
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.
At baseline, 3, 6, and12 months
Symptom burden
Time Frame: At baseline, 3, 6 and 12 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, 3, 6 and 12 months
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.
At baseline, 3, 6, and12 months
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.
At 3 and 12 months
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.
At 3 and 12 months
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.
Up to 12 months
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gelareh Sadigh, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAQ221CD (Other Identifier: CTEP)
  • UG1CA189828 (U.S. NIH Grant/Contract)
  • NCI-2023-02646 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • ECOG-ACRIN-EAQ221CD (Other Identifier: DCP)
  • R01CA262312 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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