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Support program using text messages and phone counseling for breast cancer patients on hormonal therapy

Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions

Phase 3 Interventional Alliance for Clinical Trials in Oncology · NCT04379570

This study is testing whether a support program that includes text message reminders and phone counseling can help breast cancer patients stick to their hormone therapy better than usual care.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1180 (estimated)
Ages18 Years and up
SexFemale
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionschemotherapy
Locations525 sites (Birmingham, Alabama and 524 other locations)
Trial IDNCT04379570 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness of an additional support program that includes text message reminders and telephone-based counseling to improve medication adherence among breast cancer patients receiving endocrine therapy. Participants are randomized into four groups: one receiving only text reminders, another receiving only counseling, a third receiving both, and a control group receiving usual care. The primary objective is to compare adherence rates at 12 months, with secondary objectives extending to 24 months. The study aims to address the issue of poor medication adherence, which is a significant barrier to effective treatment for hormone receptor positive breast cancer patients.

Who should consider this trial

Good fit: Ideal candidates are women with stage I-III, hormone receptor positive, HER2-negative invasive breast cancer who have initiated endocrine therapy within the last six months.

Not a fit: Patients with a history of previous cancer or those who do not meet the specific hormone receptor and HER2 status criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve medication adherence among breast cancer patients, leading to better treatment outcomes.

How similar studies have performed: Other studies have shown promising results with similar approaches to improving medication adherence, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 524 other locations

+475 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions 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 v8
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.