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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pyrotinib.
- Who it may be relevant to
- Registry conditions: HER2 Positive Breast Cancer, Pyrotinib Treatment. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug pyrotinib
Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
Primary outcome measures
- medication adherence at 1-year [Time frame: 1-year]
Secondary outcome measures (4)
- The time to deterioration (TTD) [Time frame: time from the date of randomization to the date of the first clinically significant deterioration through study completion, an average of 2 year]
- Event-free survival (EFS) [Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.]
- Overall survival (OS) [Time frame: From date of randomization until the date of death from any cause, assessed up to 4 years]
- PRO [Time frame: From date of randomization until the date of death from any cause, assessed up to 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Publications
- Koehler F, Koehler K, Prescher S, Kirwan BA, Wegscheider K, Vettorazzi E, Lezius S, Winkler S, Moeller V, Fiss G, Schleder J, Koehler M, Zugck C, Stork S, Butter C, Prondzinsky R, Spethmann S, Angermann C, Stangl V, Halle M, von Haehling S, Dreger H, Stangl K, Deckwart O, Anker SD. Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results fr PMID 33328035
Identifiers
NCT: NCT06958627 · NCC4587