NCT07454499

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Digital Endocrine therapy Symptom Monitoring and Education Intervention	Patients will receive text messages with links to symptom monitoring surveys and educational materials on possible symptoms from endocrine therapy.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-11-30
• Completion: 2027-12-31
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States