AzTrials
AzTrials

Anatomic Stage I Breast Cancer AJCC v8Phase 3NCT04379570

Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy

A Phase 3 study testing Educational Intervention, Text Message-based Navigation Intervention and Motivational Interviewing in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 526 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Educational Intervention, Text Message-based Navigation Intervention and Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,167 participants
Where
526 sitesUnited States
Study dates
15 Feb 2021to 4 Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult
  • Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months (>=548 days) prior to registration.
  • If a patient has undergone neo-adjuvant chemotherapy and had no residual invasive disease at the time of surgery, eligibility can be based on a clinical stage I-III prior to treatment and pathologic confirmation of receptor status from a diagnostic biopsy.
  • Hormone receptor positive is defined as estrogen receptor (ER) and/or progesterone receptor (PR) or both of > 1%
  • HER2-neu negative is defined as 0-1+ by immunohistochemical (IHC) analysis, or non-amplified by fluorescence in situ hybridization (FISH) analysis. If HER2-neu status is unknown due to insufficient tissue for evaluation, the patient is eligible
  • Patients with synchronous primary tumor foci of different receptor phenotypes, whether in the same or contralateral breast, may be enrolled as long as one tumor focus meets the receptor criteria and the patient is otherwise eligible

Prior Treatment:

  • Patients must have completed all planned cancer-directed surgery (except reconstruction surgery or oophorectomy)
  • Patients must have completed all other adjuvant therapy (e.g., radiation and intravenous [IV] or oral chemotherapy) prior to registration
  • Patients who will be taking a CDK4/6 inhibitor (e.g., abemaciclib, palbociclib, or ribociclib) during endocrine therapy are NOT permitted to enroll as this is considered ongoing adjuvant therapy
  • Patients who have previously been on ET drug outside the 6-month window for any reason, including breast cancer prevention or high-risk non-malignant lesions (e.g., atypical ductal hyperplasia [ADH], lobular carcinoma in situ [LCIS]) are ineligible
  • Patients must be taking a once daily endocrine therapy drug initiated within the 6 months prior to registration, OR have received a prescription for a once daily ET medication with stated intent to initiate within 6 weeks after registration.
  • Patients who switch ET drugs prior to enrollment remain eligible as long as the total time since initiation of the first ET drug does not exceed 6 months prior to registration
  • Patients who have stopped their ET drug prior to enrollment and not started another ET drug are ineligible
  • 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 with a history of high-risk breast lesions (e.g., atypical ductal hyperplasia - ADH, lobular carcinoma in situ - LCIS are eligible as long as they have not previously taken an endocrine therapy drug
  • 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
  • A smart phone and service can be provided to the participant at no cost for the duration of the study activities if the participant meets at least one of the following criteria: (1) does not own a smart phone or (2) has limited data, minutes or texting plan or (3) their smart phone cannot support the Alliance electronic patient reported outcomes (ePRO) survey app. Study provided smart phones will be provided through the Ohio State University (OSU) partnership with Verizon Wireless.
  • 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
  • Patients must be willing to use the AdhereTech medication electronic pill cap for the duration of study participation
  • Patients must be willing to use the study-provided electronic pill cap as a medication event monitoring system each time ET drug is taken. Use of any other container (e.g., pill box, etc.) for ET drug during study period is not permitted
  • Age >= 18 years
  • In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
  • Co-enrollment is allowed with the permission of the Alliance Executive Officer and both studies' Study Chairs

Trial locations and contacts

526 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • UM Upper Chesapeake Hematology and Oncology - Aberdeen

    Aberdeen, Maryland, 21001

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • Aultman Alliance Community Hospital

    Alliance, Ohio, 44601

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • UTMB Health Angleton Danbury Campus

    Angleton, Texas, 77515

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • Ascension Saint Elizabeth Hospital

    Appleton, Wisconsin, 54915

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Hematology Oncology Associates of Central New York-Auburn

    Auburn, New York, 13021

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Baptist Hospitals of Southeast Texas Cancer Center

    Beaumont, Texas, 77701

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • UCSF Cancer Center - Berkeley

    Berkeley, California, 94702

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Ballad Health Cancer Care - Bristol

    Bristol, Virginia, 24201

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Hematology Oncology Associates of CNY at Camillus

    Camillus, New York, 13031

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Cancer Specialists of Tidewater Limited

    Chesapeake, Virginia, 23320

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Medical Center

    Chico, California, 95926

  • Adventist Health Cancer Care Center Chico

    Chico, California, 95973

  • Ascension Calumet Hospital

    Chilton, Wisconsin, 53014

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • MercyOne Genesis Davenport Medical Center

    Davenport, Iowa, 52803

  • MercyOne Genesis Davenport Cancer Center

    Davenport, Iowa, 52804

  • Iowa Cancer Specialists

    Davenport, Iowa, 52807

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Broward Health North

    Deerfield Beach, Florida, 33064

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Columbus Oncology and Hematology Associates

    Dublin, Ohio, 43016

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Main Line Health Center-Exton

    Exton, Pennsylvania, 19341

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

  • Southpointe-Sanford Medical Center Fargo

    Fargo, North Dakota, 58103

  • Sanford Medical Center Fargo

    Fargo, North Dakota, 58104

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Augusta Health Center for Cancer and Blood Disorders

    Fishersville, Virginia, 22939

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Ascension Saint Francis - Reiman Cancer Center

    Franklin, Wisconsin, 53132

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • Arizona Center for Cancer Care - Gilbert

    Gilbert, Arizona, 85297

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Peninsula Cancer Institute-Gloucester

    Gloucester, Virginia, 23061

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • East Carolina University

    Greenville, North Carolina, 27834

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Kaiser Permanente South Bay

    Harbor City, California, 90710

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Essentia Health - Jamestown Clinic

    Jamestown, North Dakota, 58401

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Ballad Health Cancer Care - Kingsport

    Kingsport, Tennessee, 37660

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Marshfield Medical Center - Ladysmith

    Ladysmith, Wisconsin, 54848

  • Kaiser Permanente-Rock Creek

    Lafayette, Colorado, 80026

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

  • Condell Memorial Hospital

    Libertyville, Illinois, 60048

  • CaroMont Health - Lincoln Cancer Center

    Lincolnton, North Carolina, 28092

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Kaiser Permanente-Lone Tree

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

  • Banner McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Redeemer Health

    Meadowbrook, Pennsylvania, 19046

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

  • Aspirus Medford Hospital

    Medford, Wisconsin, 54451

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Summa Health Medina Medical Center

    Medina, Ohio, 44256

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • Ascension Columbia Saint Mary's Hospital Ozaukee

    Mequon, Wisconsin, 53097

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Ascension Columbia Saint Mary's Hospital - Milwaukee

    Milwaukee, Wisconsin, 53211

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Educational Intervention, Text Message-based Navigation Intervention, Motivational Interviewing, Best Practice, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational InterventionOther

    Receive online educational information about ET medication

  • Text Message-based Navigation InterventionOther

    Receive text messages

  • Motivational InterviewingBehavioural

    Receive motivational interviewing counseling sessions

  • Best PracticeOther

    Also called Standard of Care

    Attend usual care clinic visits

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Ancillary studies

Study groups in NCT04379570
Study groupRoleWhat they receive
Arm I (TMR)ExperimentalPatients 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.
Receives: Other: Educational Intervention; Other: Text Message-based Navigation Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment
Arm II (MI)ExperimentalPatients 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.
Receives: Other: Educational Intervention; Behavioral: Motivational Interviewing; Other: Questionnaire Administration; Other: Quality-of-Life Assessment
Arm III (TMR + MI)ExperimentalPatients 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.
Receives: Other: Educational Intervention; Other: Text Message-based Navigation Intervention; Behavioral: Motivational Interviewing; Other: Questionnaire Administration; Other: Quality-of-Life Assessment
Arm IV (enhanced usual care)Active comparatorPatients 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.
Receives: Other: Educational Intervention; Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endocrine therapy (ET) adherence at 12 months post-randomization

    ET adherence at 12 months post-randomization will be measured by electronic pill monitoring cap (AdhereTech-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 292 of 365 days.

    Measured: At 12 months post-randomization

Secondary outcomes (1)

  1. 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.

    Measured: At 24 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start15 Feb 2021
  3. Primary completion4 Oct 2026
  4. Study completion4 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04379570
Sponsor's protocol ID
A191901
Other IDs
NCI-2020-02479, UG1CA189823, R01CA237357
Status last verified
Oct 2026
First submitted
5 May 2020
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Ivory J, Wheeler SB, Drier S, Gunn H, Zahrieh D, Paskett E, Naughton M, Wills R, Swetel K, Chow S, Reeder-Hayes K. Randomized phase III trial evaluating motivational interviewing and text interventions to optimize adherence to breast cancer endocrine therapy (Alliance A191901): the GETSET protocol. Trials. 2023 Oct 12;24(1):664. doi: 10.1186/s13063-023-07672-8.

    PubMed 37828596

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Educational Intervention, Text Message-based Navigation Intervention and Motivational Interviewing in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 526 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 526 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endocrine therapy (ET) adherence at 12 months post-randomization (time frame: At 12 months post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04379570, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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