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Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)

NCT07454499 · Abramson Cancer Center at Penn Medicine
In plain English

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About this study
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.
Eligibility criteria
Inclusion Criteria: * Participants must identify as a woman * Participants must be age 18 or older * Participants must have a diagnosis of Stage 0, I, II, or III HR+ breast cancer * Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole) within 16 weeks of study registration. * Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization. * Participants who received chemotherapy must have finished it at least 14 days prior to randomization. * Speak and read in English * Own an internet-enabled cell phone * Capable of using the electronic pill bottle * Concomitant radiotherapy is allowed. Concomitant maintenance targeted or biologic therapy (e.g., anti-HER2 therapy, osteoclast inhibitor therapy, CDK 4/6 inhibitor, ovarian function suppression medications) is allowed. Exclusion Criteria: * Metastatic (Stage IV) breast cancer * Male gender * Prior treatment with endocrine therapy for breast cancer * Communication difficulties such as: Uncorrected or uncompensated hearing and/or vision impairment, uncorrected or uncompensated speech defects, uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-13
Estimated completion: 2027-12-31
Last updated: 2026-06-12
Interventions
Behavioral: Digital Endocrine therapy Symptom Monitoring and Education Intervention
Primary outcomes
  • System Usability Scale (SUS) (Once during study exit survey at 6 months)
  • Feasibility- recruitment rates and intervention completion rates (Consent to study exit survey at 6 months)
Sponsor
Abramson Cancer Center at Penn Medicine · other
With: Fox Chase Cancer Center, National Cancer Institute (NCI)
Contacts & investigators
ContactKimberley Lee · contact · kimberley.lee@pennmedicine.upenn.edu · 215-615-1736
ContactKelsey Karpink · contact · kelsey.karpink@pennmedicine.upenn.edu · 215-662-3531
InvestigatorKimberley Lee, MD · principal_investigator, University of Pennsylvania
All locations (1)
Abramson Cancer Center at the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE) · TrialPath