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Clinical Trials in Israel / NCT04379570
Active, not recruiting Phase 3

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

NCT04379570 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2021-02-15
Last updated
2026-10-01

Condition(s) studied

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2 Negative Breast CarcinomaHormone Receptor Positive Breast CarcinomaInvasive Breast CarcinomaPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8

Investigational drug(s) / intervention(s)

Educational InterventionText Message-based Navigation InterventionMotivational InterviewingBest PracticeQuestionnaire AdministrationQuality-of-Life Assessment

Educational Intervention: Receive online educational information about ET medication

Text Message-based Navigation Intervention: Receive text messages

Motivational Interviewing: Receive motivational interviewing counseling sessions

Best Practice: Attend usual care clinic visits

Questionnaire Administration: Ancillary studies

Quality-of-Life Assessment: Ancillary studies

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
• 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

Primary outcome measure(s)

Trial sites (526)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
Fairbanks Memorial Hospital Fairbanks Alaska
Arizona Center for Cancer Care - Gilbert Gilbert Arizona
Arizona Center for Cancer Care-Peoria Peoria Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
Arizona Center for Cancer Care - Phoenix Phoenix Arizona
Arizona Center for Cancer Care - Osborn Scottsdale Arizona
Arizona Center for Cancer Care - Scottsdale Scottsdale Arizona
Arizona Center for Cancer Care-Surprise Surprise Arizona
Mercy Hospital Fort Smith Fort Smith Arkansas
Kaiser Permanente-Anaheim Anaheim California
Kaiser Permanente-Deer Valley Medical Center Antioch California
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
Sutter Auburn Faith Hospital Auburn California
Kaiser Permanente-Baldwin Park Baldwin Park California
Kaiser Permanente-Bellflower Bellflower California
UCSF Cancer Center - Berkeley Berkeley California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Enloe Medical Center Chico California
Adventist Health Cancer Care Center Chico Chico California
Kaiser Permanente Dublin Dublin California
Kaiser Permanente-Fontana Fontana California
Kaiser Permanente-Fremont Fremont California
Palo Alto Medical Foundation-Fremont Fremont California
Kaiser Permanente-Fresno Fresno California
Kaiser Permanente South Bay Harbor City California
Kaiser Permanente-Irvine Irvine California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Kaiser Permanente West Los Angeles Los Angeles California
Fremont - Rideout Cancer Center Marysville California
Kaiser Permanente-Modesto Modesto California
Palo Alto Medical Foundation-Camino Division Mountain View California
Kaiser Permanente-Oakland Oakland California
Kaiser Permanente-Ontario Ontario California
Desert Regional Medical Center Palm Springs California
Palo Alto Medical Foundation Health Care Palo Alto California
Kaiser Permanente - Panorama City Panorama City California
Kaiser Permanente-Richmond Richmond California
Kaiser Permanente-Riverside Riverside California
Kaiser Permanente-Roseville Roseville California

+ 486 more sites — see the full list on the official registry below.

More Alliance for Clinical Trials in Oncology trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04379570 on ClinicalTrials.gov ↗ ← All trials in Israel