The Impact of Intelligent Patient Management Model on Medication Adherence of Pyrotinib Compared to Traditional Patient Management Model: a Prospective, Multicenter, Randomized Controlled Clinical Study

Summary

This is a prospective, multicenter, randomized controlled clinical study to evaluate the effect of using intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment. Pyrotinib is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit HER1, HER2, and HER4.

Eligibility

Inclusion Criteria:

* Female patients aged ≥ 18 years.
* Histologically confirmed HER2-positive breast cancer (IHC 3+ or IHC 2+ with ISH+).
* Patients expected to receive pyrotinib-containing regimens for neoadjuvant therapy or metastatic/unresectable breast cancer.

  ·≤1 prior line of anti-HER2 therapy during the recurrent/metastatic stage.
* Ability to operate a mobile phone and read independently.
* Deemed psychologically and physically suitable for participation by the investigator.

Exclusion Criteria:

* History of cognitive impairment.
* Severe visual or auditory impairments.
* Prior use of pyrotinib.
* Pregnancy, lactation, or intention to conceive.
* Ineffective cognitive-behavioral interventions within the past year.
* Participation in other clinical trials within 1 month prior to screening.
* Investigator judgment of unsuitability due to psychological or physical conditions.

Conditions4

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