UPCC 24124 Emshape Engaging Mobile Health for Symptom Monitoring and Health Promotion for Black Women on Endocrine Therapy for Breast Cancer

We propose an iterative approach to develop and pilot test a new mHealth behavioral intervention for AET adherence that is culturally tailored to Black breast cancer survivors. We will first use qualitative methods informed by Black breast cancer survivors to develop a blueprint of the intervention (Aim 1). We will then iteratively refine and culturally tailor the mHealth intervention focusing on symptom monitoring and management (Aim 2). Lastly, we will test the intervention for acceptability, feasibility, and preliminary efficacy (Aim 3). This project will address quality of life (symptom burden) and care delivery (medication adherence) issues in a health disparity population. Feasibility will be evaluated via rates of recruitment and EmSHAPE intervention completion. For recruitment, the feasibility criterion will be a consent rate of 60% of eligible patients who are approached for participation. The criterion for intervention feasibility will be completion rate of 60% of all questionnaires and urine specimen collections. Both criteria must be met for the study to be considered feasible. Acceptability will be determined via patient reported satisfaction with the intervention. Participants randomized to EmSHAPE will be asked at the exit assessment to Please rate your overall satisfaction with EmSHAPE (i.e., 1=very unsatisfied, 5=very satisfied). The intervention will be considered acceptable if 50% of randomized participants report that they are satisfied or very satisfied with the intervention. Adherence (Primary efficacy outcome). Urine metabolites of endocrine therapy (ET) will be measured at 26 weeks and 52 weeks ( 4 weeks. This window will allow for real-life patient considerations, including scheduling and missed visits. Adherence failure will be defined as a negative urine test or failure to provide a urine specimen within the approved timeframe. Self-reported adherence will also be measured every 12 weeks using Voils Domains of Subjective Extent non-adherence scale.

Patient Reported Outcomes (Secondary efficacy outcomes) Participants will complete questionnaires at 12, 24, 36, and 48 weeks (+/- 14 days).

        Beliefs about necessity of taking ET and consequences of not taking it will be measured every 12 weeks via the Beliefs about Medicines questionnaire.
        Self-efficacy will be measure every 12 weeks via the PROMIS Short Form v1.0 Self-efficacy for managing symptoms scale.
        ET Symptoms will be measured every 12 weeks via the Functional Assessment of Cancer Therapy Endocrine symptoms (FACT-ES) questionnaire, which measures side-effects from ET and BC related quality of life,58 and PROMIS Self-efficacy managing symptoms scales.

You may be eligible for this study if you meet the following criteria:

• Conditions: Medical Research
• Age: 99 years or below
• Gender: All