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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04379570
Other study ID # A191901
Secondary ID NCI-2020-02479UG
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 15, 2021
Est. completion date October 2025

Study information

Verified date May 2024
Source Alliance for Clinical Trials in Oncology
Contact Katherine E. Reeder-Hayes, MD
Phone 919-445-6147
Email kreeder@med.unc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.


Description:

PRIMARY OBJECTIVES: I. Compare endocrine therapy (ET) adherence at 12 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care. SECONDARY OBJECTIVES: l. Compare endocrine therapy (ET) adherence at 24 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care. OUTLINE: Patients are randomized to 1 of 4 arms. ARM I (TMR): Patients receive online educational information about ET at the start of their ET medication. Patients also receive daily text message reminders to take their ET medication and monthly text messages about how they are doing with taking their ET medication. These text messages continue for 9 months. ARM II (MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive a total of 5 motivational interviewing counseling sessions via telephone over 30-90 minutes for up to 9 months. These sessions are designed to support patients while they take their ET medication, develop health goals, and stay on track in achieving those goals. ARM III (TMR + MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive text messages as in Arm I and motivational interviewing counseling sessions as in Arm II. ARM IV (ENHANCED USUAL CARE): Patients attend usual care clinic visits every 3-6 months and receive online educational information about ET at the start of their ET medication. Patients also receive optional online information about living a healthy life after breast cancer. After completion of study participation, patients are followed up for up to 24 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 1180
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility - Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months prior to enrollment - Women who have undergone neo-adjuvant chemotherapy who have no residual invasive disease post-surgery are eligible based on an initial pathologically confirmed diagnosis - Hormone receptor positive is defined as estrogen receptor (ER) and/or progesterone receptor (PR) of > 1% - HER2-neu negative is defined as 0-1+ by immunohistochemical (IHC) analysis, or non-amplified by fluorescence in situ hybridization (FISH) analysis - Patients must have received cancer-directed surgery, and/or completed all other adjuvant therapy, except reconstruction - Patients must have initiated an endocrine therapy drug within the 6 months prior to registration, OR have received a prescription with stated intent to initiate within 6 weeks after registration - No history of previous cancer as follows: - Invasive or non-invasive breast cancer at any time - Non-breast cancer, within the past 5 years, excluding non-melanoma skin cancer - Patients must be willing to use a smart phone for study activities - Patient is NOT to be deemed ineligible during the recruitment process if they do not have a smart phone - If a participant does not own a smart phone or has limited data or texting capabilities or their smart phone cannot support the Alliance electronic patient reported outcomes (ePRO) survey application (app), a smart phone and service can be provided to the participant at no cost through the Ohio State University (OSU) partnership with Verizon Wireless for the duration of the study activities - The CRP is ONLY to discuss this option with those patients who self-identify a phone-related barrier to participation, including: lack of a smart phone, insufficient phone plan (minutes/text/data), or a smart phone incompatible with the Alliance ePRO app - For OSU -provided phones, charges will be paid by the grant through the intervention period. At the end of the 12-month intervention period, patients will be responsible for paying monthly fees, if continued service is desired. The physical phones will belong to the patients at the end of their study activities - Patients must be willing to use a Pillsy medication event monitoring system for the duration of study participation - In order to complete the mandatory patient-completed measures, participants must be able to speak and read English

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational Intervention
Receive online educational information about ET medication
Text Message-based Navigation Intervention
Receive text messages
Behavioral:
Motivational Interviewing
Receive motivational interviewing counseling sessions
Other:
Best Practice
Attend usual care clinic visits
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies

Locations

Country Name City State
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Summa Health System - Akron Campus Akron Ohio
United States Phoebe Putney Memorial Hospital Albany Georgia
United States Mayo Clinic Health System in Albert Lea Albert Lea Minnesota
United States Presbyterian Kaseman Hospital Albuquerque New Mexico
United States Aultman Alliance Community Hospital Alliance Ohio
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 Kaiser Permanente-Anaheim Anaheim California
United States AnMed Health Cancer Center Anderson South Carolina
United States UTMB Health Angleton Danbury Campus Angleton Texas
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States Luminis Health Anne Arundel Medical Center Annapolis Maryland
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Ascension Saint Elizabeth Hospital Appleton Wisconsin
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Duluth Clinic Ashland Ashland Wisconsin
United States Hematology Oncology Associates of Central New York-Auburn Auburn New York
United States MultiCare Auburn Medical Center Auburn Washington
United States Sutter Auburn Faith Hospital Auburn California
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Mercy Medical Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Summa Health System - Barberton Campus Barberton Ohio
United States Advocate Good Shepherd Hospital Barrington Illinois
United States Bronson Battle Creek Battle Creek Michigan
United States Baptist Hospitals of Southeast Texas Cancer Center Beaumont Texas
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States UM Upper Chesapeake Medical Center Bel Air Maryland
United States Kaiser Permanente-Bellflower Bellflower California
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States UCSF Cancer Center - Berkeley Berkeley California
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Beverly Hospital Beverly Massachusetts
United States Billings Clinic Cancer Center Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States McFarland Clinic - Boone Boone Iowa
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Bristol Regional Medical Center Bristol Tennessee
United States Wellmont Medical Associates-Bristol Bristol Virginia
United States Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield Wisconsin
United States Maimonides Medical Center Brooklyn New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States Fairview Ridges Hospital Burnsville Minnesota
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 Aultman Health Foundation Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Trinity Health Medical Center - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Waverly Hematology Oncology Cary North Carolina
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Physicians' Clinic of Iowa PC Cedar Rapids Iowa
United States Rocky Mountain Cancer Centers - Centennial Centennial Colorado
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Cancer Specialists of Tidewater Limited Chesapeake Virginia
United States Advocate Illinois Masonic Medical Center Chicago Illinois
United States Adventist Health Cancer Care Center Chico Chico California
United States Enloe Medical Center Chico California
United States Ascension Calumet Hospital Chilton Wisconsin
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Main Line Health Center-Collegeville Collegeville Pennsylvania
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Cookeville Regional Medical Center Cookeville Tennessee
United States Mercy Hospital Coon Rapids Minnesota
United States AMG Crystal Lake - Oncology Crystal Lake Illinois
United States Danbury Hospital Danbury Connecticut
United States Carle at The Riverfront Danville Illinois
United States Genesis Cancer Care Institute Davenport Iowa
United States Genesis Medical Center - East Campus Davenport Iowa
United States Iowa Cancer Specialists Davenport Iowa
United States Dayton Physician LLC - Englewood Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Broward Health North Deerfield Beach Florida
United States Kaiser Permanente-Franklin Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Illinois CancerCare-Dixon Dixon Illinois
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Advocate Good Samaritan Hospital Downers Grove Illinois
United States Columbus Oncology and Hematology Associates Dublin Ohio
United States Kaiser Permanente Dublin Dublin California
United States Essentia Health Cancer Center Duluth Minnesota
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Advocate Sherman Hospital Elgin Illinois
United States Walter Knox Memorial Hospital Emmett Idaho
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Rocky Mountain Cancer Centers - Swedish Englewood Colorado
United States Illinois CancerCare-Eureka Eureka Illinois
United States Main Line Health Center-Exton Exton Pennsylvania
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Medical Center Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Southpointe-Sanford Medical Center Fargo Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Augusta Health Center for Cancer and Blood Disorders Fishersville Virginia
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Kaiser Permanente-Fontana Fontana California
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Broward Health Medical Center Fort Lauderdale Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Essentia Health - Fosston Fosston Minnesota
United States Beebe South Coastal Health Campus Frankford Delaware
United States Ascension Saint Francis - Reiman Cancer Center Franklin Wisconsin
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States CentraState Medical Center Freehold New Jersey
United States Kaiser Permanente-Fremont Fremont California
United States Palo Alto Medical Foundation-Fremont Fremont California
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States University of Texas Medical Branch Galveston Texas
United States CaroMont Regional Medical Center Gastonia North Carolina
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Arizona Center for Cancer Care - Gilbert Gilbert Arizona
United States UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Peninsula Cancer Institute-Gloucester Gloucester Virginia
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Banner North Colorado Medical Center Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States East Carolina University Greenville North Carolina
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Kaiser Permanente - Harbor City Harbor City California
United States Ingalls Memorial Hospital Harvey Illinois
United States Advocate South Suburban Hospital Hazel Crest Illinois
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States Cancer Center of Kansas-Independence Independence Kansas
United States Kaiser Permanente-Irvine Irvine California
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States McFarland Clinic - Jefferson Jefferson Iowa
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Ascension Borgess Cancer Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Ballad Health Cancer Care - Kingsport Kingsport Tennessee
United States Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee
United States Marshfield Medical Center - Ladysmith Ladysmith Wisconsin
United States Kaiser Permanente-Rock Creek Lafayette Colorado
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Doctor's Hospital of Laredo Laredo Texas
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States UTMB Cancer Center at Victory Lakes League City Texas
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States AMG Libertyville - Oncology Libertyville Illinois
United States Condell Memorial Hospital Libertyville Illinois
United States CaroMont Health - Lincoln Cancer Center Lincolnton North Carolina
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Kaiser Permanente-Lone Tree Lone Tree Colorado
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
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United States Kaiser Permanente West Los Angeles Los Angeles California
United States Banner McKee Medical Center Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
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 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Fremont - Rideout Cancer Center Marysville California
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Redeemer Health Meadowbrook Pennsylvania
United States Bon Secours Memorial Regional Medical Center Mechanicsville Virginia
United States Aspirus Medford Hospital Medford Wisconsin
United States Riddle Memorial Hospital Media Pennsylvania
United States Summa Health Medina Medical Center Medina Ohio
United States Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin
United States Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Center Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States Trinity Medical Center Moline Illinois
United States Monticello Cancer Center Monticello Minnesota
United States Virtua Samson Cancer Center Moorestown New Jersey
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States CarolinaEast Medical Center New Bern North Carolina
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Providence Newberg Medical Center Newberg Oregon
United States Peninsula Cancer Institute-Newport News Newport News Virginia
United States Cancer Center of Kansas - Newton Newton Kansas
United States Bon Secours DePaul Medical Center Norfolk Virginia
United States Southwest VA Regional Cancer Center Norton Virginia
United States Norwalk Hospital Norwalk Connecticut
United States Ascension Providence Hospitals - Novi Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Drexel Town Square Health Center Oak Creek Wisconsin
United States Advocate Christ Medical Center Oak Lawn Illinois
United States Kaiser Permanente-Oakland Oakland California
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States Kaiser Permanente-Ontario Ontario California
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Ascension Mercy Hospital Oshkosh Wisconsin
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Kaiser Permanente - Panorama City Panorama City California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Lahey Medical Center-Peabody Peabody Massachusetts
United States Illinois CancerCare-Pekin Pekin Illinois
United States Arizona Center for Cancer Care-Peoria Peoria Arizona
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Arizona Center for Cancer Care - Phoenix Phoenix Arizona
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Phoenixville Hospital Phoenixville Pennsylvania
United States Penn Medicine Princeton Health Plainsboro New Jersey
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Providence Portland Medical Center Portland Oregon
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United States Bon Secours Maryview Medical Center Portsmouth Virginia
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Pottstown Hospital Pottstown Pennsylvania
United States Vassar Brothers Medical Center Poughkeepsie New York
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Rhode Island Hospital Providence Rhode Island
United States Women and Infants Hospital Providence Rhode Island
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United States Ascension All Saints Hospital Racine Wisconsin
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Northwest Hospital Center Randallstown Maryland
United States Corewell Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
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United States Valley Medical Center Renton Washington
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Bon Secours Cancer Institute at Reynolds Crossing Richmond Virginia
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States VCU Massey Cancer Center at Stony Point Richmond Virginia
United States Virginia Cancer Institute Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho New Mexico
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United States Kaiser Permanente-Riverside Riverside California
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota
United States Memorial Hospital of Sweetwater County Rock Springs Wyoming
United States OSF Saint Anthony Medical Center Rockford Illinois
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States Kaiser Permanente Downtown Commons Sacramento California
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United States Sutter Medical Center Sacramento Sacramento California
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
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 Missouri Baptist Medical Center 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 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Kaiser Permanente-San Diego Zion San Diego California
United States Kaiser Permanente-San Francisco San Francisco California
United States Zuckerberg San Francisco General Hospital San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Kaiser Permanente-San Marcos San Marcos California
United States UCSF Cancer Center - San Mateo San Mateo California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Essentia Health Sandstone Sandstone Minnesota
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Saint John's Cancer Institute Santa Monica California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Memorial Health University Medical Center Savannah Georgia
United States Summit Cancer Care-Memorial Savannah Georgia
United States Arizona Center for Cancer Care - Osborn Scottsdale Arizona
United States Arizona Center for Cancer Care - Scottsdale Scottsdale Arizona
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Welch Cancer Center Sheridan Wyoming
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Genesis Cancer Center - Silvis Silvis Illinois
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Spartanburg Medical Center Spartanburg South Carolina
United States MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Bon Secours Health Center at Harbour View Suffolk Virginia
United States Cancer Specialists of Tidewater-Suffolk Suffolk Virginia
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Arizona Center for Cancer Care-Surprise Surprise Arizona
United States Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York
United States State University of New York Upstate Medical University Syracuse New York
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Tallahassee Memorial HealthCare Tallahassee Florida
United States Holy Name Hospital Teaneck New Jersey
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States UM Saint Joseph Medical Center Towson Maryland
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States MGC Hematology Oncology-Union Union South Carolina
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Upstate Cancer Center at Verona Verona New York
United States Inspira Medical Center Vineland Vineland New Jersey
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Peninsula Cancer Institute-Cancer Specialists of Tidewater Virginia Beach Virginia
United States Virtua Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Saint Joseph Warren Hospital Warren Ohio
United States Kent Hospital Warwick Rhode Island
United States Mercy Hospital Washington Washington Missouri
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States AdventHealth Infusion Center Weaverville Weaverville North Carolina
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin
United States Methodist West Hospital West Des Moines Iowa
United States Good Samaritan University Hospital West Islip New York
United States William E Kahlert Regional Cancer Center/Sinai Hospital Westminster Maryland
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Peninsula Cancer Institute-Williamsburg Williamsburg Virginia
United States Rice Memorial Hospital Willmar Minnesota
United States Winchester Hospital Winchester Massachusetts
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Fairview Lakes Medical Center Wyoming Minnesota
United States University of Michigan Health - West Wyoming Michigan
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endocrine therapy (ET) adherence at 12 months post-randomization ET adherence at 12 months post-randomization will be measured by electronic pill monitoring cap (Pillsy-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 292 of 365 days. At 12 months post-randomization
Secondary Endocrine therapy (ET) adherence at 24 months post-randomization ET adherence at 24 months post-randomization will be measured by electronic pill monitoring cap (Pillsy-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 584 of 730 days. At 24 months post-randomization
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