Engaging mobile health for symptom monitoring and health promotion during endocrine therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a culturally tailored mobile health intervention that uses symptom monitoring and education for women with early HR+ breast cancer who are starting oral endocrine therapy. Participants will use a digital tool and electronic pill bottle to monitor side effects and receive guidance to support adherence. The aim is to see if this approach can improve symptom management and help patients stay on therapy for the recommended duration. The trial is randomized and targets women in the early-stage setting, with outcomes focused on adherence and symptom experiences. The study will inform future work on how well these tools work in real-world care.

Why it matters

Who can join: the full rules

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

Where it's running

• Abramson Cancer Center at the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Kimberley Lee, MD — University of Pennsylvania
• Study coordinator: Kimberley Lee
• Email: kimberley.lee@pennmedicine.upenn.edu
• Phone: 215-615-1736

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.