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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Digital Endocrine therapy Symptom Monitoring and Education Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberley Lee; Phone Number: 215-615-1736; Email: kimberley.lee@pennmedicine.upenn.edu
• Study Contact Backup: Name: Kelsey Karpink; Phone Number: 215-662-3531; Email: kelsey.karpink@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center at the University of Pennsylvania
      • Contact: Kimberley Lee, MD; Email: kimberley.lee@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM A Intervention; Patients assigned to symptom monitoring web-based intervention.	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.
No Intervention: ARM B Usual care; Participants will be provided with an educational handout describing endocrine therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale (SUS)	Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability)	Once during study exit survey at 6 months
Feasibility- recruitment rates and intervention completion rates	Evaluated via rates of recruitment and intervention completion	Consent to study exit survey at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endocrine therapy adherence	Proportion of days participant takes medication	Day 1 though study completion, an average of 48 weeks
FACTS-ES likert variables	Side effects of endocrine therapy	Assessed at baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: National Cancer Institute (NCI); Fox Chase Cancer Center
• Investigators: Principal Investigator: Kimberley Lee, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: UPCC 24124; IRB# 856525 (Other Identifier: Penn IRB); K08CA279076 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No