The purpose of the study is to learn more about ways to help patients understand and manage side-effects from hormone therapy. The investigators will use the information from this study to design future studies to better understand how our well our tools work to help patients monitor and manage symptoms from hormone therapy and to stay on their hormone therapy for the recommended period of time.
Despite robust available data supporting the efficacy of oral endocrine therapy (ET) for the treatment of breast cancer and the low adherence to this life-saving treatment, only 6 randomized controlled trials have assessed interventions to improve adherence to ET; only 1 showed modest short-term benefit. ET adherence is critical, as 10-year survival decreases from 81% when adherent to 74% when non-adherent to ET. The investigators propose a first of its kind, randomized, culturally tailored mHealth intervention trial called "EmSHAPE"- Engaging mobile health for symptom monitoring and health promotion for endocrine therapy - among newly diagnosed women with early hormone receptor positive breast cancer. Prior intervention studies have not been effective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Patients will receive text messages with links to symptom monitoring surveys and educational materials on possible symptoms from endocrine therapy.
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGSystem Usability Scale (SUS)
Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability)
Time frame: Once during study exit survey at 6 months
Feasibility- recruitment rates and intervention completion rates
Evaluated via rates of recruitment and intervention completion
Time frame: Consent to study exit survey at 6 months
Endocrine therapy adherence
Proportion of days participant takes medication
Time frame: Day 1 though study completion, an average of 48 weeks
FACTS-ES likert variables
Side effects of endocrine therapy
Time frame: Assessed at baseline (T0), 12 weeks (T1), and 24 weeks (T2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.