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

NCT07454499 | Not Yet Recruiting

• 3 other identifiers: UPCC 24124IRB# 856525K08CA279076
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Endocrine therapy adherence

  Day 1 though study completion, an average of 48 weeks

• FACTS-ES likert variables

  Assessed at baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Study Arms (2)

ARM A Intervention

EXPERIMENTAL

Patients assigned to symptom monitoring web-based intervention.

Behavioral: Digital Endocrine therapy Symptom Monitoring and Education Intervention

ARM B Usual care

NO INTERVENTION

Participants will be provided with an educational handout describing endocrine therapy.

Interventions

Digital Endocrine therapy Symptom Monitoring and Education Intervention BEHAVIORAL

Patients will receive text messages with links to symptom monitoring surveys and educational materials on possible symptoms from endocrine therapy.

ARM A Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must identify as a woman.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Fox Chase Cancer Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kimberley Lee, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberley Lee

CONTACT

215-615-1736; kimberley.lee@pennmedicine.upenn.edu

Kelsey Karpink

CONTACT

215-662-3531; kelsey.karpink@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: March 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)