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Search / Trial NCT04379570

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

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · May 5, 2020

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how an additional support program, which includes text message reminders and phone counseling, can help breast cancer patients stick to their prescribed medication for hormonal therapy. Taking this medication as directed is crucial for effective treatment, especially for women with hormone receptor positive breast cancer. The trial aims to see if these extra reminders and support can improve how consistently patients take their medication compared to standard care.

To participate, women must be diagnosed with stage I-III hormone receptor positive breast cancer within the last 18 months and have begun their hormonal therapy recently. They should also be willing to use a smartphone and a special monitoring system to track their medication. If a participant doesn’t have a smartphone, one can be provided for free during the study. Throughout the trial, participants can expect to receive support via text and phone calls to help them manage their treatment better. This study is currently recruiting participants, and it hopes to find out how these support methods can lead to better health outcomes for breast cancer patients.

Gender

FEMALE

Eligibility criteria

  • 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

About Alliance For Clinical Trials In Oncology

The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.

Locations

Brooklyn, New York, United States

Milwaukee, Wisconsin, United States

Providence, Rhode Island, United States

Flint, Michigan, United States

Kalamazoo, Michigan, United States

Burnsville, Minnesota, United States

Edina, Minnesota, United States

Waconia, Minnesota, United States

Harvey, Illinois, United States

Peoria, Illinois, United States

Galveston, Texas, United States

Tallahassee, Florida, United States

Des Moines, Iowa, United States

Great Falls, Montana, United States

Cleveland, Ohio, United States

Baltimore, Maryland, United States

Poughkeepsie, New York, United States

Saint Paul, Minnesota, United States

Greeley, Colorado, United States

Loveland, Colorado, United States

Chanute, Kansas, United States

Dodge City, Kansas, United States

Newton, Kansas, United States

Wellington, Kansas, United States

Winfield, Kansas, United States

Kalamazoo, Michigan, United States

Bozeman, Montana, United States

Kalispell, Montana, United States

Sheridan, Wyoming, United States

New Brunswick, New Jersey, United States

Mount Vernon, Illinois, United States

Bryn Mawr, Pennsylvania, United States

Laredo, Texas, United States

Salina, Kansas, United States

Coon Rapids, Minnesota, United States

Renton, Washington, United States

Urbana, Illinois, United States

Wichita, Kansas, United States

Annapolis, Maryland, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

Shakopee, Minnesota, United States

Willmar, Minnesota, United States

Dayton, Ohio, United States

Effingham, Illinois, United States

Independence, Kansas, United States

Saint Joseph, Missouri, United States

Greenville, Ohio, United States

Mount Vernon, Ohio, United States

Wisconsin Rapids, Wisconsin, United States

Springfield, Illinois, United States

Downers Grove, Illinois, United States

Anderson, South Carolina, United States

Portland, Oregon, United States

Roseville, California, United States

Hazel Crest, Illinois, United States

Springfield, Illinois, United States

Englewood, New Jersey, United States

Media, Pennsylvania, United States

Boston, Massachusetts, United States

Honolulu, Hawaii, United States

Minneapolis, Minnesota, United States

Aurora, Colorado, United States

Birmingham, Alabama, United States

Savannah, Georgia, United States

Topeka, Kansas, United States

Bethesda, Maryland, United States

Southfield, Michigan, United States

Duluth, Minnesota, United States

Columbia, Missouri, United States

Saint Louis, Missouri, United States

Syracuse, New York, United States

Chapel Hill, North Carolina, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Columbus, Ohio, United States

Wynnewood, Pennsylvania, United States

Kingsport, Tennessee, United States

Amarillo, Texas, United States

Aurora, Illinois, United States

Canton, Ohio, United States

Kettering, Ohio, United States

Auburn, Washington, United States

Puyallup, Washington, United States

Providence, Rhode Island, United States

Wyoming, Michigan, United States

Cape Girardeau, Missouri, United States

Honolulu, Hawaii, United States

Albany, Georgia, United States

Fridley, Minnesota, United States

Robbinsdale, Minnesota, United States

Saint Louis Park, Minnesota, United States

Saint Louis, Missouri, United States

Galveston, Texas, United States

Milwaukee, Wisconsin, United States

Oak Lawn, Illinois, United States

Oakland, California, United States

Fort Lauderdale, Florida, United States

Park Ridge, Illinois, United States

Greenville, North Carolina, United States

Sioux Falls, South Dakota, United States

Houston, Texas, United States

Richmond, Virginia, United States

Sacramento, California, United States

Rochester, Minnesota, United States

Saint Louis, Missouri, United States

Green Bay, Wisconsin, United States

Madison, Wisconsin, United States

Marshfield, Wisconsin, United States

Portland, Oregon, United States

Mcpherson, Kansas, United States

Reno, Nevada, United States

Decatur, Illinois, United States

Ottawa, Illinois, United States

Peoria, Illinois, United States

El Dorado, Kansas, United States

Kingman, Kansas, United States

Parsons, Kansas, United States

Pratt, Kansas, United States

Wichita, Kansas, United States

Beverly, Massachusetts, United States

Gloucester, Massachusetts, United States

Galesburg, Illinois, United States

Cedar Rapids, Iowa, United States

Des Moines, Iowa, United States

Des Moines, Iowa, United States

Des Moines, Iowa, United States

Brainerd, Minnesota, United States

Palm Springs, California, United States

Reed City, Michigan, United States

Cape Girardeau, Missouri, United States

Peru, Illinois, United States

Livonia, Michigan, United States

Pontiac, Michigan, United States

Maplewood, Minnesota, United States

Maplewood, Minnesota, United States

Stillwater, Minnesota, United States

Great Falls, Montana, United States

Findlay, Ohio, United States

Spartanburg, South Carolina, United States

Baltimore, Maryland, United States

Freehold, New Jersey, United States

West Islip, New York, United States

Paoli, Pennsylvania, United States

Phoenixville, Pennsylvania, United States

Fremont, California, United States

Los Angeles, California, United States

Richmond, California, United States

Roseville, California, United States

Sacramento, California, United States

San Francisco, California, United States

San Francisco, California, United States

San Jose, California, United States

San Leandro, California, United States

Santa Clara, California, United States

Santa Rosa, California, United States

South San Francisco, California, United States

Stockton, California, United States

Vallejo, California, United States

Walnut Creek, California, United States

Honolulu, Hawaii, United States

Honolulu, Hawaii, United States

Galesburg, Illinois, United States

Rockford, Illinois, United States

Richmond, Indiana, United States

Ames, Iowa, United States

Davenport, Iowa, United States

Davenport, Iowa, United States

Wichita, Kansas, United States

Battle Creek, Michigan, United States

Grand Rapids, Michigan, United States

Grand Rapids, Michigan, United States

Bemidji, Minnesota, United States

Woodbury, Minnesota, United States

Joplin, Missouri, United States

Springfield, Missouri, United States

Springfield, Missouri, United States

Billings, Montana, United States

Missoula, Montana, United States

Vineland, New Jersey, United States

Voorhees, New Jersey, United States

Akron, Ohio, United States

Boardman, Ohio, United States

Dayton, Ohio, United States

Franklin, Ohio, United States

Troy, Ohio, United States

Warren, Ohio, United States

Youngstown, Ohio, United States

Sioux Falls, South Dakota, United States

Gloucester, Virginia, United States

Newport News, Virginia, United States

Richmond, Virginia, United States

Williamsburg, Virginia, United States

Tacoma, Washington, United States

Eau Claire, Wisconsin, United States

Green Bay, Wisconsin, United States

Mequon, Wisconsin, United States

Milwaukee, Wisconsin, United States

Minocqua, Wisconsin, United States

Oconomowoc, Wisconsin, United States

Oconto Falls, Wisconsin, United States

Racine, Wisconsin, United States

Rice Lake, Wisconsin, United States

Sheboygan, Wisconsin, United States

Waukesha, Wisconsin, United States

Wausau, Wisconsin, United States

West Allis, Wisconsin, United States

Weston, Wisconsin, United States

Kettering, Ohio, United States

Berkeley, California, United States

Mountain View, California, United States

Palo Alto, California, United States

Colorado Springs, Colorado, United States

Norwalk, Connecticut, United States

Cedar Rapids, Iowa, United States

Burlington, Massachusetts, United States

Albuquerque, New Mexico, United States

Newark, Ohio, United States

Springfield, Ohio, United States

Antigo, Wisconsin, United States

Wausau, Wisconsin, United States

Chico, California, United States

Libertyville, Illinois, United States

Livonia, Michigan, United States

East Syracuse, New York, United States

Newberg, Oregon, United States

Oshkosh, Wisconsin, United States

New Ulm, Minnesota, United States

Denver, Colorado, United States

Marysville, California, United States

Danbury, Connecticut, United States

Moline, Illinois, United States

Hendersonville, North Carolina, United States

Norton, Virginia, United States

Saint Joseph, Michigan, United States

Elgin, Illinois, United States

Honolulu, Hawaii, United States

Goldsboro, North Carolina, United States

Chippewa Falls, Wisconsin, United States

Canton, Illinois, United States

Carthage, Illinois, United States

Eureka, Illinois, United States

Kewanee, Illinois, United States

Macomb, Illinois, United States

Peru, Illinois, United States

Princeton, Illinois, United States

Boise, Idaho, United States

Fargo, North Dakota, United States

Shreveport, Louisiana, United States

Joplin, Missouri, United States

Walla Walla, Washington, United States

Grafton, Wisconsin, United States

Ft. Smith, Arkansas, United States

Greenville, South Carolina, United States

Greenville, South Carolina, United States

Cookeville, Tennessee, United States

Fort Smith, Arkansas, United States

Truckee, California, United States

Deerfield Beach, Florida, United States

Post Falls, Idaho, United States

Bloomington, Illinois, United States

Chicago, Illinois, United States

Pekin, Illinois, United States

Liberal, Kansas, United States

Towson, Maryland, United States

Saint Louis, Missouri, United States

Cary, North Carolina, United States

Barberton, Ohio, United States

Bend, Oregon, United States

Pottstown, Pennsylvania, United States

Warwick, Rhode Island, United States

Boiling Springs, South Carolina, United States

Easley, South Carolina, United States

Greenville, South Carolina, United States

Greenville, South Carolina, United States

Greer, South Carolina, United States

Seneca, South Carolina, United States

Burlington, Wisconsin, United States

Germantown, Wisconsin, United States

Green Bay, Wisconsin, United States

Kenosha, Wisconsin, United States

Marinette, Wisconsin, United States

Milwaukee, Wisconsin, United States

Racine, Wisconsin, United States

Summit, Wisconsin, United States

Two Rivers, Wisconsin, United States

Wauwatosa, Wisconsin, United States

Wisconsin Rapids, Wisconsin, United States

Teaneck, New Jersey, United States

Fairbanks, Alaska, United States

Vacaville, California, United States

Denver, Colorado, United States

Lafayette, Colorado, United States

River Forest, Illinois, United States

Jefferson City, Missouri, United States

Plainsboro, New Jersey, United States

Gastonia, North Carolina, United States

Hendersonville, North Carolina, United States

Oklahoma City, Oklahoma, United States

Meadowbrook, Pennsylvania, United States

Richmond, Virginia, United States

Anaheim, California, United States

Antioch, California, United States

Baldwin Park, California, United States

Bellflower, California, United States

Chico, California, United States

Fontana, California, United States

Fresno, California, United States

Harbor City, California, United States

Irvine, California, United States

Los Angeles, California, United States

Modesto, California, United States

Panorama City, California, United States

Riverside, California, United States

San Diego, California, United States

San Marcos, California, United States

Sunnyvale, California, United States

Woodland Hills, California, United States

West Des Moines, Iowa, United States

Bel Air, Maryland, United States

Rolla, Missouri, United States

Rolla, Missouri, United States

Fargo, North Dakota, United States

Columbus, Ohio, United States

Portsmouth, Ohio, United States

New Richmond, Wisconsin, United States

Urbana, Illinois, United States

Randallstown, Maryland, United States

Springfield, Illinois, United States

Belpre, Ohio, United States

Columbus, Ohio, United States

Springfield, Ohio, United States

Great Falls, Montana, United States

Auburn, California, United States

Santa Cruz, California, United States

Newark, Delaware, United States

Newark, Delaware, United States

Rehoboth Beach, Delaware, United States

Caldwell, Idaho, United States

Coeur D'alene, Idaho, United States

Emmett, Idaho, United States

Meridian, Idaho, United States

Nampa, Idaho, United States

Sandpoint, Idaho, United States

Manhattan, Kansas, United States

Brighton, Michigan, United States

Brighton, Michigan, United States

Canton, Michigan, United States

Canton, Michigan, United States

Chelsea, Michigan, United States

Chelsea, Michigan, United States

Clarkston, Michigan, United States

Flint, Michigan, United States

Flint, Michigan, United States

Livonia, Michigan, United States

Pontiac, Michigan, United States

Ypsilanti, Michigan, United States

Ypsilanti, Michigan, United States

Minneapolis, Minnesota, United States

Anaconda, Montana, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Clinton, North Carolina, United States

Jacksonville, North Carolina, United States

Centerville, Ohio, United States

Baker City, Oregon, United States

Ontario, Oregon, United States

Cody, Wyoming, United States

Lakewood, Colorado, United States

Lexington, Kentucky, United States

Lexington, Kentucky, United States

Boulder, Colorado, United States

Denver, Colorado, United States

Englewood, Colorado, United States

Littleton, Colorado, United States

Lone Tree, Colorado, United States

Savannah, Georgia, United States

Carbondale, Illinois, United States

Carterville, Illinois, United States

Centralia, Illinois, United States

Danville, Illinois, United States

Decatur, Illinois, United States

Effingham, Illinois, United States

Mattoon, Illinois, United States

O'fallon, Illinois, United States

Yorkville, Illinois, United States

Brighton, Michigan, United States

Canton, Michigan, United States

Chelsea, Michigan, United States

Ypsilanti, Michigan, United States

Maple Grove, Minnesota, United States

Wyoming, Minnesota, United States

Sainte Genevieve, Missouri, United States

Sullivan, Missouri, United States

Sunset Hills, Missouri, United States

Asheville, North Carolina, United States

Centerville, Ohio, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Findlay, Ohio, United States

Findlay, Ohio, United States

Franklin, Ohio, United States

Greenville, Ohio, United States

Troy, Ohio, United States

Clackamas, Oregon, United States

Bristol, Tennessee, United States

Kingsport, Tennessee, United States

Bristol, Virginia, United States

Spokane, Washington, United States

Spokane, Washington, United States

Sturgeon Bay, Wisconsin, United States

Lone Tree, Colorado, United States

Ames, Iowa, United States

Boone, Iowa, United States

Fort Dodge, Iowa, United States

Jefferson, Iowa, United States

Marshalltown, Iowa, United States

Auburn, New York, United States

Syracuse, New York, United States

Richmond, Virginia, United States

Dublin, California, United States

Sacramento, California, United States

San Rafael, California, United States

Westminster, Maryland, United States

Novi, Michigan, United States

Monticello, Minnesota, United States

Henderson, Nevada, United States

Las Vegas, Nevada, United States

Medina, Ohio, United States

Gaffney, South Carolina, United States

Greer, South Carolina, United States

Union, South Carolina, United States

Beaumont, Texas, United States

League City, Texas, United States

Gig Harbor, Washington, United States

Appleton, Wisconsin, United States

Brookfield, Wisconsin, United States

Eau Claire, Wisconsin, United States

Franklin, Wisconsin, United States

Oshkosh, Wisconsin, United States

Stevens Point, Wisconsin, United States

Ladysmith, Wisconsin, United States

Fremont, California, United States

Port Townsend, Washington, United States

Milwaukee, Wisconsin, United States

Scottsdale, Arizona, United States

Scottsdale, Arizona, United States

Fishersville, Virginia, United States

Menomonee Falls, Wisconsin, United States

Mukwonago, Wisconsin, United States

West Bend, Wisconsin, United States

Waukesha, Wisconsin, United States

Winchester, Massachusetts, United States

Ontario, California, United States

Des Moines, Iowa, United States

Peoria, Arizona, United States

Albert Lea, Minnesota, United States

Midlothian, Virginia, United States

Glen Burnie, Maryland, United States

Phoenix, Arizona, United States

San Luis Obispo, California, United States

Santa Maria, California, United States

Las Vegas, Nevada, United States

Moorestown, New Jersey, United States

Rio Rancho, New Mexico, United States

Gilbert, Arizona, United States

Phoenix, Arizona, United States

Surprise, Arizona, United States

Beavercreek, Ohio, United States

Virginia Beach, Virginia, United States

Stevens Point, Wisconsin, United States

New Bern, North Carolina, United States

Arroyo Grande, California, United States

Deer River, Minnesota, United States

Hibbing, Minnesota, United States

Sandstone, Minnesota, United States

Virginia, Minnesota, United States

Collegeville, Pennsylvania, United States

Exton, Pennsylvania, United States

Ashland, Wisconsin, United States

Medford, Wisconsin, United States

Norfolk, Virginia, United States

Honolulu, Hawaii, United States

Ballwin, Missouri, United States

Washington, Missouri, United States

Gilbert, Arizona, United States

Fort Dodge, Iowa, United States

Worthington, Minnesota, United States

Clyde, North Carolina, United States

Mechanicsville, Virginia, United States

Wauwatosa, Wisconsin, United States

'Aiea, Hawaii, United States

Detroit Lakes, Minnesota, United States

Fosston, Minnesota, United States

Park Rapids, Minnesota, United States

Jamestown, North Dakota, United States

Oak Creek, Wisconsin, United States

Springfield, Ohio, United States

Fargo, North Dakota, United States

Libertyville, Illinois, United States

Centennial, Colorado, United States

Englewood, Colorado, United States

Dixon, Illinois, United States

Farmington, Missouri, United States

Las Vegas, Nevada, United States

Frankford, Delaware, United States

Peabody, Massachusetts, United States

Burnsville, Minnesota, United States

Richmond, Virginia, United States

Chilton, Wisconsin, United States

Bozeman, Montana, United States

Alliance, Ohio, United States

San Mateo, California, United States

Silvis, Illinois, United States

Davenport, Iowa, United States

Cambridge, Minnesota, United States

Princeton, Minnesota, United States

Barrington, Illinois, United States

Crystal Lake, Illinois, United States

Kalamazoo, Michigan, United States

Thief River Falls, Minnesota, United States

Oneida, New York, United States

Weaverville, North Carolina, United States

Dublin, Ohio, United States

Missoula, Montana, United States

Angleton, Texas, United States

Chesapeake, Virginia, United States

Suffolk, Virginia, United States

Annapolis, Maryland, United States

Fargo, North Dakota, United States

Fargo, North Dakota, United States

Portsmouth, Virginia, United States

Suffolk, Virginia, United States

Greeley, Colorado, United States

'Aiea, Hawaii, United States

Springfield, Illinois, United States

Santa Monica, California, United States

Phoenix, Arizona, United States

Berkeley, California, United States

Rock Springs, Wyoming, United States

Kalispell, Montana, United States

West Islip, New York, United States

Wyoming, Michigan, United States

Grand Rapids, Michigan, United States

Troy, Ohio, United States

Nampa, Idaho, United States

Meadowbrook, Pennsylvania, United States

Pontiac, Michigan, United States

Ann Arbor, Michigan, United States

Brighton, Michigan, United States

Chelsea, Michigan, United States

Danville, Illinois, United States

Boone, Iowa, United States

Fort Dodge, Iowa, United States

Jefferson, Iowa, United States

Marshalltown, Iowa, United States

Ames, Iowa, United States

Canton, Michigan, United States

Ladysmith, Wisconsin, United States

Minocqua, Wisconsin, United States

Columbia, Missouri, United States

Verona, New York, United States

Sunset Hills, Missouri, United States

Reed City, Michigan, United States

Saint Joseph, Michigan, United States

Aberdeen, Maryland, United States

Des Moines, Iowa, United States

Scottsdale, Arizona, United States

Scottsdale, Arizona, United States

Lincolnton, North Carolina, United States

Grand Rapids, Michigan, United States

Loveland, Colorado, United States

Jefferson City, Missouri, United States

Madison, Wisconsin, United States

Dayton, Ohio, United States

Sandpoint, Idaho, United States

Baker City, Oregon, United States

Ontario, Oregon, United States

Millville, Delaware, United States

Camillus, New York, United States

Southfield, Michigan, United States

Novi, Michigan, United States

Madison, Wisconsin, United States

Flint, Michigan, United States

Norton, Virginia, United States

Bristol, Virginia, United States

Harbor City, California, United States

Mount Vernon, Illinois, United States

Des Moines, Iowa, United States

Aiea, Hawaii, United States

Davenport, Iowa, United States

Rolla, Missouri, United States

Davenport, Iowa, United States

Silvis, Illinois, United States

Cape Girardeau, Missouri, United States

Union, South Carolina, United States

Winchester, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Katherine E. Reeder-Hayes, MD

Study Chair

University of North Carolina, Chapel Hill

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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