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 (any)
Status and phase
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Female patients aged ≥ 18 years.
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Histologically confirmed HER2-positive breast cancer (IHC 3+ or IHC 2+ with ISH+).
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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.
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Ability to operate a mobile phone and read independently.
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
964 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Jiani Wang, M.D.
Data sourced from clinicaltrials.gov
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