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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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
April 1, 2026
Primary Completion Date
November 30, 2027
Completion Date
December 31, 2027
Last Updated
March 6, 2026
60
ESTIMATED participants
Digital Endocrine therapy Symptom Monitoring and Education Intervention
BEHAVIORAL
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
NCT05673200
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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