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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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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
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Minneapolis, Minnesota, United States
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Bethesda, Maryland, United States
Southfield, Michigan, United States
Duluth, Minnesota, United States
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Bismarck, North Dakota, United States
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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
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Fort Lauderdale, Florida, United States
Park Ridge, Illinois, United States
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Portland, Oregon, United States
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Reno, Nevada, United States
Decatur, Illinois, United States
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Peoria, Illinois, United States
El Dorado, Kansas, United States
Kingman, Kansas, United States
Parsons, Kansas, United States
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Gloucester, Massachusetts, United States
Galesburg, Illinois, United States
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Brainerd, Minnesota, United States
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Peru, Illinois, United States
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Pontiac, Michigan, United States
Maplewood, Minnesota, United States
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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
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Honolulu, Hawaii, United States
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Galesburg, Illinois, United States
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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
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Billings, Montana, United States
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Vineland, New Jersey, United States
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Akron, Ohio, United States
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Franklin, Ohio, United States
Troy, Ohio, United States
Warren, Ohio, United States
Youngstown, Ohio, United States
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Gloucester, Virginia, United States
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Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
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Boise, Idaho, United States
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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
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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
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Pekin, Illinois, United States
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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
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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
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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
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Harbor City, California, United States
Irvine, California, United States
Los Angeles, California, United States
Modesto, California, United States
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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
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Rehoboth Beach, Delaware, United States
Caldwell, Idaho, United States
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Meridian, Idaho, United States
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Sandpoint, Idaho, United States
Manhattan, Kansas, United States
Brighton, Michigan, United States
Brighton, Michigan, United States
Canton, Michigan, United States
Canton, Michigan, United States
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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
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Las Vegas, Nevada, United States
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Clinton, North Carolina, United States
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Centerville, Ohio, United States
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Englewood, Colorado, United States
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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
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Sullivan, Missouri, United States
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Asheville, North Carolina, United States
Centerville, Ohio, United States
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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
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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