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

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.

Conditions

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

Interventions

OTHER

Educational Intervention

Receive online educational information about ET medication

OTHER

Text Message-based Navigation Intervention

Receive text messages

BEHAVIORAL

Motivational Interviewing

Receive motivational interviewing counseling sessions

OTHER

Best Practice

Attend usual care clinic visits

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Katherine E. Reeder-Hayes, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-15

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• United States

Study Locations