Mobile Health for Adherence in Breast Cancer Patients
Launched by ECOG-ACRIN CANCER RESEARCH GROUP · Oct 27, 2023
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to help breast cancer patients remember to take their medication as prescribed. It compares two methods: one group will use a special medication monitoring device called WiseBag along with reminders sent via text messages, while the other group will only use the WiseBag. The goal is to see if these reminders can improve how well patients stick to their treatment schedule when taking a specific type of medication known as CKD4/6 inhibitors. These medications are important for helping patients with metastatic breast cancer, which means their cancer has spread to other parts of the body.
To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of hormone receptor-positive, HER2-negative metastatic breast cancer. They should have started their CKD4/6 medication recently and must be able to use a mobile phone for text messages. Participants will be asked to monitor their medication adherence and might share their experiences through surveys. The trial is currently looking for participants, and it aims to find a better way to support patients in taking their medications regularly, which is crucial for their treatment success.
Gender
ALL
Eligibility 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 (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
About Ecog Acrin Cancer Research Group
The ECOG-ACRIN Cancer Research Group is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative clinical trials and rigorous scientific inquiry. As a collaborative network of researchers, healthcare professionals, and institutions, ECOG-ACRIN focuses on improving cancer treatment and patient outcomes by conducting high-quality, multicenter studies. Their research spans various cancer types and includes a wide array of therapeutic approaches, emphasizing the integration of cutting-edge methodologies and patient-centered care. Committed to fostering collaboration and sharing knowledge, ECOG-ACRIN plays a vital role in transforming cancer care and enhancing the understanding of cancer biology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brooklyn, New York, United States
Flint, Michigan, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Edina, Minnesota, United States
Waconia, Minnesota, United States
Baton Rouge, Louisiana, United States
Great Falls, Montana, United States
Saint Paul, Minnesota, United States
Kalamazoo, Michigan, United States
Traverse City, Michigan, United States
Bozeman, Montana, United States
Kalispell, Montana, United States
Sheridan, Wyoming, United States
Cincinnati, Ohio, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Lewes, Delaware, United States
Mount Vernon, Illinois, United States
Houma, Louisiana, United States
Yakima, Washington, United States
Coon Rapids, Minnesota, United States
Renton, Washington, United States
Urbana, Illinois, United States
Minneapolis, Minnesota, United States
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Shakopee, Minnesota, United States
Willmar, Minnesota, United States
Council Bluffs, Iowa, United States
Saint Joseph, Missouri, United States
Greenville, Ohio, United States
Bethlehem, Pennsylvania, United States
Wisconsin Rapids, Wisconsin, United States
Longmont, Colorado, United States
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Augusta, Georgia, United States
Detroit, Michigan, United States
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Las Vegas, Nevada, United States
Morristown, New Jersey, United States
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Green Bay, Wisconsin, United States
Marshfield, Wisconsin, United States
Reno, Nevada, United States
Cedar Rapids, Iowa, United States
Cedar Rapids, Iowa, United States
Warren, Michigan, United States
Lincoln, Nebraska, United States
Papillion, Nebraska, United States
Omaha, Nebraska, United States
Maplewood, Minnesota, United States
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Stillwater, Minnesota, United States
Great Falls, Montana, United States
Findlay, Ohio, United States
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Wilkes Barre, Pennsylvania, United States
Kalamazoo, Michigan, United States
Scranton, Pennsylvania, United States
Los Angeles, California, United States
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Richmond, Indiana, United States
New Orleans, Louisiana, United States
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Lafayette, Colorado, United States
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Richmond, Virginia, United States
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Norton Shores, Michigan, United States
Monticello, Minnesota, United States
Columbus, Mississippi, United States
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Southhaven, Mississippi, United States
Carson City, Nevada, United States
Henderson, Nevada, United States
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Brookfield, Wisconsin, United States
Eau Claire, Wisconsin, United States
Franklin, Wisconsin, United States
Oshkosh, Wisconsin, United States
London, Kentucky, United States
Port Townsend, Washington, United States
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Santa Maria, California, United States
Woodland, California, United States
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Tawas City, Michigan, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Bayamon, , Puerto Rico
Henderson, Nevada, United States
Pahrump, Nevada, United States
Beavercreek, Ohio, United States
Stevens Point, Wisconsin, United States
Bayamon, , Puerto Rico
Manati, , Puerto Rico
Winchester, Virginia, United States
Arroyo Grande, California, United States
Pompton, New Jersey, United States
Hazleton, Pennsylvania, United States
Collierville, Tennessee, United States
Ballwin, Missouri, United States
Washington, Missouri, United States
Denver, Colorado, United States
Worthington, Minnesota, United States
Mechanicsville, Virginia, United States
Wauwatosa, Wisconsin, United States
Fargo, North Dakota, United States
Chadds Ford, Pennsylvania, United States
Kingman, Arizona, United States
Centennial, Colorado, United States
Englewood, Colorado, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Colorado Springs, Colorado, United States
Englewood, Colorado, United States
Frankford, Delaware, United States
Burnsville, Minnesota, United States
Richmond, Virginia, United States
Chilton, Wisconsin, United States
Franklin, Wisconsin, United States
Newton, New Jersey, United States
San Juan, , Puerto Rico
Bozeman, Montana, United States
Jackson, Mississippi, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Kalamazoo, Michigan, United States
Thief River Falls, Minnesota, United States
Midlothian, Virginia, United States
Milwaukee, Wisconsin, United States
Neenah, Wisconsin, United States
New London, Wisconsin, United States
Shawano, Wisconsin, United States
Waupaca, Wisconsin, United States
Missoula, Montana, United States
Oshkosh, Wisconsin, United States
Little Rock, Arkansas, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
Baton Rouge, Louisiana, United States
Lexington, Kentucky, United States
Sheboygan, Wisconsin, United States
Hackettstown, New Jersey, United States
Berlin, Wisconsin, United States
Mount Sterling, Kentucky, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Centralia, Illinois, United States
Richmond, Virginia, United States
Neillsville, Wisconsin, United States
Paducah, Kentucky, United States
San Juan, , Puerto Rico
Danville, Illinois, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Merced, California, United States
Canton, Michigan, United States
Ladysmith, Wisconsin, United States
Osage Beach, Missouri, United States
Ankeny, Iowa, United States
Niles, Michigan, United States
Reed City, Michigan, United States
Saint Joseph, Michigan, United States
Des Moines, Iowa, United States
Lansing, Michigan, United States
Carmichael, California, United States
Grand Rapids, Michigan, United States
Saint Joseph, Michigan, United States
Pontiac, Michigan, United States
Silverdale, Washington, United States
Dayton, Ohio, United States
Grand Rapids, Michigan, United States
Sandpoint, Idaho, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Walnut Creek, California, United States
Patients applied
Trial Officials
Gelareh Sadigh
Principal Investigator
ECOG-ACRIN Cancer Research Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported