NCI ID NCI-2020-02479
NCT ID NCT04379570
CTEP ID A191901
Anatomic Sites Breast
Minimum Age 18 Years
Maximum Age 999 Years
Lead Org Alliance for Clinical Trials in Oncology
Principal Investigator Katherine E. Reeder-Hayes
NCI Site View on

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

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.


Inclusion Criterea

  • 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 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 Ohio State University (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

Exclusion Criterea

Participating Clinics

Comprehensive Cancer Centers of Nevada - Central Valley

3730 South Eastern Avenue
Las Vegas, NV 89169


OptumCare Cancer Care at MountainView

3150 North Tenaya Way
Suite 510 Las Vegas, NV 89128


OptumCare Cancer Care at Seven Hills

3175 Saint Rose Parkway
Suite 200 Henderson, NV 89052


Hope Cancer Care of Nevada

6827 West Tropicana Avenue
Suite 110 Las Vegas, NV 89103


Saint Mary's Regional Medical Center

235 West Sixth Street
Reno, NV 89503


OptumCare Cancer Care at Charleston

2300 West Charleston Boulevard
Las Vegas, NV 89102


OptumCare Cancer Care at Fort Apache

6190 South Fort Apache Road
Las Vegas, NV 89148


Valley Medical Center

400 South 43rd Street
Renton, WA 98055