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

  • STATUS
    Recruiting
  • End date
    Oct 12, 2025
  • participants needed
    1180
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 12 September 2021
Investigator
Katie Reeder-Hayes, MD
Primary Contact
Centralia Oncology Clinic (0.4 mi away) Contact
+368 other location

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.

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.

Details
Condition Invasive Breast Carcinoma, Invasive Breast Cancer, Anatomic Stage III Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Hormone Receptor Positive Breast Carcinoma, HER2 Negative Breast Carcinoma
Treatment questionnaire administration, quality-of-life assessment, educational intervention, Motivational Interviewing, Best Practice, Text Message-Based Navigation Intervention
Clinical Study IdentifierNCT04379570
SponsorAlliance for Clinical Trials in Oncology
Last Modified on12 September 2021

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