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

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT04379570
Trial Phases:	Phase III	Protocol IDs:	A191901 (primary) A191901 A191901 NCI-2020-02479
Eligibility:	18 Years and older, Female	Study Type:	Supportive care
Study Sponsor:	Alliance for Clinical Trials in Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT04379570

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.

Objectives

PRIMARY OBJECTIVE:
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.

EXPLORATORY OBJECTIVES:
I. Evaluate the effects of TMR, MI and TMR+MI interventions on secondary patient-reported outcomes, including medication use self-efficacy (MUSE), health related quality of life (HRQOL), cancer worry, and knowledge and attitudes about ET, relative to usual care.
II. Describe the incremental resources used and value of delivering TMR, MI, and TMR+MI interventions, relative to usual care.
III. Difference in disease-free survival including ductal carcinoma in situ (DCIS) (DFS-DCIS), to be defined according to standard definition as patients free of invasive ipsilateral recurrence, local/regional invasive recurrence, distant recurrence, death from any cause, invasive contralateral breast cancer, ipsilateral or contralateral DCIS, or second primary invasive non-breast cancer), between patients randomized to the TMR-only, MI-only, and TMR+MI interventions relative to usual care.
IV. The pattern of accrual on Black and younger patients will be assessed at the initial 50% of accrual enrolled and at the end of the trial.

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.

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