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EmSHAPE: Digital Support for Women on Endocrine Therapy for Breast Cancer

This study, called EmSHAPE, is looking at a new way to help women manage side effects from hormone therapy (endocrine therapy) for breast cancer. If you have Stage 0, I, II, or III HR+ (hormone receptor positive) breast cancer and have recently started oral endocrine therapy like tamoxifen, anastrozole, exemestane, or letrozole, you might be able to join. The study will test a digital intervention where you receive text messages with links to surveys about your symptoms and educational materials. Researchers want to see how easy this system is to use and how many people complete the intervention over six months. The goal is to find better ways to support patients and help them stay on their important hormone therapy.

Study design
This is an interventional study planning to enroll 60 women. It will test a behavioral intervention involving digital tools.
What's involved
You would participate in symptom monitoring surveys and receive educational materials via text messages for six months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at six months, which is the study exit survey.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07454499

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

Recruiting
NAAges 18+InterventionalSupportive care
Abramson Cancer Center at Penn Medicine
~60 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Digital Endocrine therapy Symptom Monitoring and Education Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
System Usability Scale (SUS)
Measured over Once during study exit survey at 6 months
+1 more outcome measured

Conditions

Cancer

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Breast CarcinomaHR LYSINE DEMETHYLASE AND NUCLEAR RECEPTOR COREPRESSOR

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Kimberley Lee, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Kimberley Lee
[email protected]
215-615-1736
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • System Usability Scale (SUS)Once during study exit survey at 6 months

    Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability)

  • Feasibility- recruitment rates and intervention completion ratesConsent to study exit survey at 6 months

    Evaluated via rates of recruitment and intervention completion