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

Phase 3

Recruiting

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Invasive Breast Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; HER2 Negative Breast Carcinoma; Hormone Receptor Positive Breast Carcinoma; Prognostic Stage II Breast Cancer AJCC v8

• Registration Number: NCT04379570
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Detailed Description

PRIMARY OBJECTIVES:

I. Compare endocrine therapy (ET) adherence at 12 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care.

SECONDARY OBJECTIVES:

l. Compare endocrine therapy (ET) adherence at 24 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I (TMR): Patients receive online educational information about ET at the start of their ET medication. Patients also receive daily text message reminders to take their ET medication and monthly text messages about how they are doing with taking their ET medication. These text messages continue for 9 months.

ARM II (MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive a total of 5 motivational interviewing counseling sessions via telephone over 30-90 minutes for up to 9 months. These sessions are designed to support patients while they take their ET medication, develop health goals, and stay on track in achieving those goals.

ARM III (TMR + MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive text messages as in Arm I and motivational interviewing counseling sessions as in Arm II.

ARM IV (ENHANCED USUAL CARE): Patients attend usual care clinic visits every 3-6 months and receive online educational information about ET at the start of their ET medication. Patients also receive optional online information about living a healthy life after breast cancer.

After completion of study participation, patients are followed up for up to 24 months.

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-07
• Study Start: 2021-02-15
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-26
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endocrine therapy (ET) adherence at 12 months post-randomization	At 12 months post-randomization	ET adherence at 12 months post-randomization will be measured by electronic pill monitoring cap (Pillsy-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 292 of 365 days.

Secondary Outcome Measures

Name	Time	Method
Endocrine therapy (ET) adherence at 24 months post-randomization	At 24 months post-randomization	ET adherence at 24 months post-randomization will be measured by electronic pill monitoring cap (Pillsy-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 584 of 730 days.

Trial Locations

Locations (526)

University of Alabama at Birmingham Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Fairbanks Memorial Hospital; 🇺🇸 Fairbanks, Alaska, United States

Arizona Center for Cancer Care - Gilbert; 🇺🇸 Gilbert, Arizona, United States

Arizona Center for Cancer Care-Peoria; 🇺🇸 Peoria, Arizona, United States

Cancer Center at Saint Joseph's; 🇺🇸 Phoenix, Arizona, United States

Arizona Center for Cancer Care - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Arizona Center for Cancer Care - Osborn; 🇺🇸 Scottsdale, Arizona, United States

Arizona Center for Cancer Care - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Arizona Center for Cancer Care-Surprise; 🇺🇸 Surprise, Arizona, United States

Mercy Hospital Fort Smith; 🇺🇸 Fort Smith, Arkansas, United States

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