Title
Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions

Description
Phase III study Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions

Objective

The purpose of this study:

You have been prescribed an ET medication to treat your breast cancer. This treatment may decrease the chance of your cancer recurring. The purpose of this study is to test if different
types of added support such as text message reminders and/or telephone based counseling can help increase your ability to take this medication regularly. The effects of these additional
support programs will be compared to basic educational material provided by your study team about ET medication

Treatment NA

Key Eligibility
Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months prior to enrollment

Women who have undergone neo-adjuvant chemotherapy who have no residual invasive disease post-surgery are eligible based on an initial pathologically confirmed diagnosis

Hormone receptor positive is defined as estrogen receptor (ER) and/or progesterone receptor (PR) of greater than 1 percent

HER2-neu negative is defined as 0-1+ by ImmunoHistoChemical (IHC) analysis, or nonamplified by Fluorescence in situ Hybridization (FISH) analysis

Must have received cancer-directed surgery, and/or completed all other adjuvant therapy, except reconstruction

Must have initiated an endocrine therapy drug within the 6 months prior to registration, OR have received a prescription with stated intent to initiate within 6 weeks after registration

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 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

If a participant does not own a smart phone or has limited data or texting capabilities or their smart phone cannot support the Alliance ePRO survey app, a smart phone and service
can be provided to the participant at no cost through the Ohio State University partnership with Verizon Wireless for the duration of the study activities

The 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

For OSU-provided phones, charges will be paid by the grant through the intervention period. At the end of the 12-month intervention period, patients will be responsible for paying monthly fees, if continued service is desired. The physical phones will belong to the patients at the end of their study activities

Must be willing to use a Pillsy medication event monitoring system for the duration of study participation

In order to complete the mandatory patient-completed measures, participants must be able to speak and read English

18 years of age or older

Applicable Disease Sites
Breast

Participating Institutions
UW Cancer Center at ProHealth; UW Health 1 S. Park Medical Center; UW Health Eastpark Medical Center; UW Health University Hospital