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.

Eligibility

1. Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months (i.e., =< 548 days) prior to registration * If a patient has undergone neo-adjuvant chemotherapy and had no residual invasive disease at the time of surgery, eligibility can be based on clinical stage I-III prior to treatment and pathologic confirmation of receptor status from a diagnostic biopsy * Hormone receptor positive is defined as estrogen receptor (ER), progesterone receptor (PR), or both of > 1% * HER2-neu negative is defined as 0-1+ by ImmunoHistoChemical (IHC) analysis, or non-amplified by Fluorescence in situ Hybridization (FISH) analysis. If HER2-neu status is unknown due to insufficient tissue for evaluation, the patient is eligible * Patients with synchronous primary tumor foci of different receptor phenotypes, whether in the same or contralateral breast, may be enrolled as long as one tumor focus meets the receptor criteria and the patient is otherwise eligible
2. Prior Treatment: * Patients must have completed all planned cancer-directed surgery (except reconstruction surgery or oophorectomy) * Patients must have completed all other adjuvant therapy (e.g., radiation and intravenous [IV] or oral chemotherapy) prior to registration * Patients who will be taking a CDK4/6 inhibitor (e.g., abemaciclib, palbociclib, or ribociclib) during endocrine therapy are NOT permitted to enroll as this is considered ongoing adjuvant therapy * Patients who have previously been on ET drug outside the 6-month window for any reason, including breast cancer prevention or high-risk non-malignant lesions (e.g., atypical ductal hyperplasia [ADH], lobular carcinoma in situ [LCIS]) are ineligible
3. Patients must be taking a once daily endocrine therapy drug initiated within the 6 months (i.e., =< 183 days) prior to registration or have received a prescription for a once daily ET medication with stated intent to initiate within 6 weeks (i.e., =< 42 days) after registration * Patients who switch ET drugs prior to enrollment remain eligible as long as the total time since initiation of the first ET drug does not exceed 6 months prior to registration * Patients who have stopped their ET drug prior to enrollment and not started another ET drug are ineligible
4. No history of previous cancer as follows: * Invasive or non-invasive breast cancer at any time * Non-breast cancer, within the past 5 years, excluding non-melanoma skin cancer * Patients with a history of high-risk breast lesions (e.g., atypical ductal hyperplasia - ADH, lobular carcinoma in situ - LCIS are eligible as long as they have not previously taken an endocrine therapy drug
5. Patients must be willing to use a smart phone for study activities * Patient is NOT to be deemed ineligible during the recruitment process if they do not have a smart phone * A smart phone and service can be provided to the participant at no cost for the duration of the study activities if the participant meets at least one of the following criteria: (1) does not own a smart phone, (2) has a limited data, minutes, or texting plan, or (3) their smart phone cannot support the Alliance electronic patient reported outcomes (ePRO) survey app. Study-provided smart phones will be provided through the Ohio State University partnership with Verizon Wireless * The Clinical Research Professional (CRP) is ONLY to discuss this option with those patients who self-identify a phone-related barrier to participation, including: lack of a smart phone, insufficient phone plan (minutes/text/data), or a smart phone incompatible with the Alliance ePRO app
6. Patients must be willing to use the AdhereTech medication electronic pill cap for the duration of study participation * Patients must be willing to use the study-provided electronic pill cap as a medication event monitoring system each time ET drug is taken. Use of any other container (e.g., pill box, etc.) for ET drug during study period is not permitted
7. Age >= 18 years
8. Language: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
9. Co-enrollment is allowed with the permission of the Alliance Executive Officer and both studies’ Study Chairs

Treatment Sites in Georgia