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Oncology Clinical Trial Finder
Breast Cancer
Location

Suspended • Phase III • Stage I, II, III • ER positive • PR positive • HER2 negative • Post-Menopausal • Brain Metastases absent • Interventional

The following is imported from ClinicalTrials.gov:

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

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.

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.

Breast Cancer

Study Design
Study type:

Interventional

Estimated enrollment:

1180 participant

Actual study start date:

February 15, 2021

Eligibility Criteria
Ages eligible for study:

18 - 999

Sexes eligible for study:

female


Arms and Intervention
  • Educational Intervention

  • Text Message-based Navigation Intervention

  • Motivational Interviewing

  • Best Practice

  • Questionnaire Administration

  • Quality-of-Life Assessment

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:

Suspended

Estimated Enrollment:

1180

Last Updated:

04/07/2023


Principal Investigator

Katherine E. Reeder-Hayes, MD


Trial Sponsor

Alliance for Clinical Trials in Oncology

Study Location (545)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mercy Medical Center

Baltimore, Maryland, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

Waverly Hematology Oncology

Cary, North Carolina, United States

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