Breast Cancer
EAQ221CD / CONCURxP
Mobile Health for Adherence in Breast Cancer Patients
STATUS: Closed to Accrual
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.
- 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 However, this is an outdated formulation and is rarely prescribed as a new start.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
United States
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Mercy Hospital
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Carle BroMenn Medical Center
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Advocate Christ Medical Center
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Advocate Lutheran General Hospital
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IN
KS
Garden City
Central Care Cancer Center - Garden City
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Central Care Cancer Center - Great Bend
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Pittsburg
Mercy Hospital Pittsburg
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Bardstown
CommonSpirit Saint Joseph Hospital - Bardstown
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Mount Sterling
CommonSpirit Saint Joseph Hospital Mount Sterling
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LA
Baton Rouge
Louisiana Hematology Oncology Associates
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New Orleans
Louisiana State University Health Science Center
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LSU Health Sciences Center at Shreveport
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MD
MI
Ann Arbor
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Brighton
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Canton
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Chelsea Hospital
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Clarkston
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Newland Medical Associates-Clarkston
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Escanaba
OSF Saint Francis Hospital and Medical Group
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Flint
Cancer Hematology Centers - Flint
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Beacon Kalamazoo
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Lansing
University of Michigan Health - Sparrow Lansing
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Henry Ford Saint John Hospital - Macomb Medical
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Marlette
Saint Mary's Oncology/Hematology Associates of Marlette
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MyMichigan Medical Center Mount Pleasant
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Cancer and Hematology Centers of Western Michigan - Norton Shores
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Hope Cancer Center
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MyMichigan Medical Center Saginaw
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Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Bhadresh Nayak MD PC-Sterling Heights
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Advanced Breast Care Center PLLC
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Saint Mary's Oncology/Hematology Associates of West Branch
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Huron Gastroenterology PC
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MN
Baxter
Essentia Health - Baxter Clinic
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Brainerd
Essentia Health Saint Joseph's Medical Center
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Coon Rapids
Mercy Hospital
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Minnesota Oncology - Coon Rapids
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Crosslake
Essentia Health - Saint Joseph's Crosslake Clinic
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Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
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Duluth
Essentia Health Cancer Center
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Miller-Dwan Hospital
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Edina
Fairview Southdale Hospital
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Ely
Essentia Health - Ely Clinic
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Hibbing
Essentia Health Hibbing Clinic
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International Falls
Essentia Health - International Falls Clinic
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Maple Grove
Fairview Clinics and Surgery Center Maple Grove
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Minnesota Oncology - Maple Grove
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Maplewood
Minnesota Oncology Hematology PA-Maplewood
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Saint John's Hospital - Healtheast
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Minneapolis
Abbott-Northwestern Hospital
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Health Partners Inc
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Moose Lake
Essentia Health - Moose Lake Clinic
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Essentia Health - Saint Joseph's Pequot Lakes Clinic
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Pine River
Essentia Health - Saint Joseph's Pine River Clinic
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Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
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Saint Paul
Regions Hospital
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United Hospital
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Staples
Essentia Health - Saint Joseph's Staples Clinic
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Sanford Thief River Falls Medical Center
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Minnesota Oncology Hematology PA-Woodbury
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Worthington
Sanford Cancer Center Worthington
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MO
Ballwin
Mercy Oncology and Hematology - Clayton-Clarkson
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Cox Cancer Center Branson
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Cape Girardeau
Mercy Cancer Center - Cape Girardeau
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Joplin
Freeman Health System
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Rolla
Mercy Clinic-Rolla-Cancer and Hematology
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Phelps Health Delbert Day Cancer Institute
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Saint Louis
Mercy Hospital Saint Louis
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Mercy Hospital South
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Mercy Infusion Center - Chippewa
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Springfield
CoxHealth South Hospital
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Washington
Mercy Hospital Washington
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MS
Columbus
Baptist Memorial Hospital and Cancer Center-Golden Triangle
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New Albany
Baptist Memorial Hospital and Cancer Center-Union County
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Baptist Memorial Hospital and Cancer Center-Oxford
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Baptist Memorial Hospital and Cancer Center-Desoto
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MT
Great Falls
Benefis Sletten Cancer Institute
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Great Falls Clinic
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NC
Hendersonville
Margaret R Pardee Memorial Hospital
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Lincolnton
CaroMont Health - Lincoln Cancer Center
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ND
Fargo
Essentia Health Cancer Center-South University Clinic
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Omaha
Alegent Health Bergan Mercy Medical Center
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NJ
Hackettstown
Hackettstown Medical Center
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Morristown
Morristown Medical Center
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Newton
Newton Medical Center
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Pompton
Chilton Medical Center
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Summit
Overlook Hospital
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NM
Albuquerque
University of New Mexico Cancer Center
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NV
Henderson
Cancer and Blood Specialists-Henderson
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Comprehensive Cancer Centers of Nevada - Henderson
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Las Vegas Urology - Green Valley
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Urology Specialists of Nevada - Green Valley
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Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Ann M Wierman MD LTD
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Comprehensive Cancer Centers of Nevada
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Hope Cancer Care of Nevada
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Las Vegas Prostate Cancer Center
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Las Vegas Urology - Cathedral Rock
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Las Vegas Urology - Smoke Ranch
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Las Vegas Urology - Sunset
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Oncology Las Vegas - Tenaya
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OptumCare Cancer Care at Charleston
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OptumCare Cancer Care at Fort Apache
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OptumCare Cancer Care at MountainView
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Radiation Oncology Centers of Nevada Central
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Radiation Oncology Centers of Nevada Southeast
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Summerlin Hospital Medical Center
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University Cancer Center
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University Medical Center of Southern Nevada
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Urology Specialists of Nevada - Central
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Urology Specialists of Nevada - Northwest
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Urology Specialists of Nevada - Southwest
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Reno
Radiation Oncology Associates
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Renown Regional Medical Center
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Saint Mary's Regional Medical Center
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NY
Bronx
Montefiore Medical Center - Moses Campus
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Montefiore Medical Center-Einstein Campus
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Montefiore Medical Center-Weiler Hospital
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Brooklyn
Maimonides Medical Center
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East Hills
The Cancer Institute at Saint Francis Hospital
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West Islip
Good Samaritan University Hospital
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OH
Centerville
Dayton Physicians LLC-Miami Valley South
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Cincinnati
Bethesda North Hospital
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Good Samaritan Hospital - Cincinnati
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Oncology Hematology Care Inc-Kenwood
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TriHealth Cancer Institute-Anderson
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TriHealth Cancer Institute-Westside
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Findlay
Armes Family Cancer Center
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Blanchard Valley Hospital
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Orion Cancer Care
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Greenville
Dayton Physicians LLC-Wayne
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Wayne Hospital
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Kettering
Greater Dayton Cancer Center
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Kettering Medical Center
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OK
Oklahoma City
Mercy Hospital Oklahoma City
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OR
Baker City
Saint Alphonsus Cancer Care Center-Baker City
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Ontario
Saint Alphonsus Cancer Care Center-Ontario
Contact: Site Public Contact
Email: [email protected]
PA
Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: [email protected]
Dickson City
Geisinger Cancer Center Dickson City
Contact: Site Public Contact
Email: [email protected]
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Contact: Site Public Contact
Email: [email protected]
Lehigh Valley Hospital-Hazleton
Contact: Site Public Contact
Email: [email protected]
Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
Contact: Site Public Contact
Email: [email protected]
PR
Bayamon
Cancer Center-Metro Medical Center Bayamon
Contact: Site Public Contact
Puerto Rico Hematology Oncology Group
Contact: Site Public Contact
Manati
Doctors Cancer Center
Contact: Site Public Contact
San Juan
Centro Comprensivo de Cancer de UPR
Contact: Site Public Contact
Email: [email protected]
PROncology
Contact: Site Public Contact
Email: [email protected]
San Juan City Hospital
Contact: Site Public Contact
San Juan Community Oncology Group
Contact: Site Public Contact
SC
Bluffton
Saint Joseph's/Candler - Bluffton Campus
Contact: Site Public Contact
Email: [email protected]
Greenville
Saint Francis Cancer Center
Contact: Site Public Contact
Email: [email protected]
Saint Francis Hospital
Contact: Site Public Contact
Email: [email protected]
Hilton Head Island
South Carolina Cancer Specialists PC
Contact: Site Public Contact
Email: [email protected]
SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: [email protected]
Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: [email protected]
TN
Collierville
Baptist Memorial Hospital and Cancer Center-Collierville
Contact: Site Public Contact
Email: [email protected]
Johnson City
Regional Cancer Center at Johnson City Medical Center
Contact: Site Public Contact
Email: [email protected]
Kingsport
Ballad Health Cancer Care - Kingsport
Contact: Site Public Contact
Email: [email protected]
Wellmont Holston Valley Hospital and Medical Center
Contact: Site Public Contact
Email: [email protected]
Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Contact: Site Public Contact
Email: [email protected]
Baptist Memorial Hospital for Women
Contact: Site Public Contact
Email: [email protected]
VA
Mechanicsville
Bon Secours Memorial Regional Medical Center
Contact: Site Public Contact
Email: [email protected]
Midlothian
Bon Secours Saint Francis Medical Center
Contact: Site Public Contact
Email: [email protected]
Bon Secours Westchester Emergency Center
Contact: Site Public Contact
Email: [email protected]
Richmond
Bon Secours Cancer Institute at Reynolds Crossing
Contact: Site Public Contact
Email: [email protected]
Bon Secours Richmond Community Hospital
Contact: Site Public Contact
Email: [email protected]
Bon Secours Saint Mary's Hospital
Contact: Site Public Contact
Email: [email protected]
VCU Massey Cancer Center at Stony Point
Contact: Site Public Contact
Email: [email protected]
VCU Massey Comprehensive Cancer Center
Contact: Site Public Contact
Email: [email protected]
WA
Port Townsend
Jefferson Healthcare
Contact: Site Public Contact
Silverdale
Saint Joseph Medical Center Hematology and Oncology - Silverdale
Contact: Site Public Contact
Email: [email protected]
Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Contact: Site Public Contact
Email: [email protected]
WI
Appleton
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Contact: Site Public Contact
Email: [email protected]
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: [email protected]
Ashland
Duluth Clinic Ashland
Contact: Site Public Contact
Email: [email protected]
Northwest Wisconsin Cancer Center
Contact: Site Public Contact
Email: [email protected]
Brookfield
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Contact: Site Public Contact
Email: [email protected]
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: [email protected]
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: [email protected]
Franklin
Ascension Southeast Wisconsin Hospital - Franklin
Contact: Site Public Contact
Email: [email protected]
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
Contact: Site Public Contact
Email: [email protected]
Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: [email protected]
Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: [email protected]
Saint Vincent Hospital Cancer Center Green Bay
Contact: Site Public Contact
Email: [email protected]
Saint Vincent Hospital Cancer Center at Saint Mary's
Contact: Site Public Contact
Email: [email protected]
Hayward
Essentia Health-Hayward Clinic
Contact: Site Public Contact
Email: [email protected]
Tamarack Health Hayward Medical Center
Contact: Site Public Contact
Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: [email protected]
Mequon
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
Contact: Site Public Contact
Email: [email protected]
Milwaukee
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
Contact: Site Public Contact
Email: [email protected]
Ascension Saint Francis Hospital-Milwaukee
Contact: Site Public Contact
Email: [email protected]
Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee
Contact: Site Public Contact
Email: [email protected]
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: [email protected]
Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: [email protected]
Aurora Sinai Medical Center
Contact: Site Public Contact
Email: [email protected]
Neenah
ThedaCare Regional Medical Center - Neenah
Contact: Site Public Contact
Email: [email protected]
Neillsville
Marshfield Medical Center - Neillsville
Contact: Site Public Contact
Email: [email protected]
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Contact: Site Public Contact
Email: [email protected]
Oshkosh
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
Contact: Site Public Contact
Email: [email protected]
ThedaCare Cancer Care - Oshkosh
Contact: Site Public Contact
Email: [email protected]
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: [email protected]
Racine
Ascension All Saints Hospital-Spring Street-Racine
Contact: Site Public Contact
Email: [email protected]
Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: [email protected]
Sheboygan
Saint Vincent Hospital Cancer Center at Sheboygan
Contact: Site Public Contact
Email: [email protected]
Sheboygan Physicians Group
Contact: Site Public Contact
Email: [email protected]
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: [email protected]
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: [email protected]
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Contact: Site Public Contact
Email: [email protected]
Superior
Essentia Health Saint Mary's Hospital - Superior
Contact: Site Public Contact
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: [email protected]
Wauwatosa
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
Contact: Site Public Contact
Email: [email protected]
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: [email protected]
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Contact: Site Public Contact
Email: [email protected]
WY
Cheyenne
Cheyenne Regional Medical Center-West
Contact: Site Public Contact
Email: [email protected]
Memorial Hospital of Laramie County
Contact: Site Public Contact
Email: [email protected]
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.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed and conducted this trial with funding from the National Cancer Institute through its NCI Community Oncology Research Program (NCORP).


Drs. Gelareh Sadigh and Ilana Graetz, and advocate Mary Lou Smith discuss the goal of improving medication adherence for breast cancer patients.
