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
NCT ID: NCT06958627
Last Updated: 2025-05-06
Study Results
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Basic Information
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RECRUITING
PHASE2/PHASE3
964 participants
INTERVENTIONAL
2024-04-30
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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intelligent patient management model
pyrotinib
Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
traditional patient management model
pyrotinib
Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
Interventions
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pyrotinib
Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
Yes
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Ma Fei，MD
Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Principal Investigators
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Jiani Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center Cancer Hospital
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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 from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial. Lancet Digit Health. 2020 Jan;2(1):e16-e24. doi: 10.1016/S2589-7500(19)30195-5. Epub 2019 Dec 12.
Other Identifiers
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NCC4587
Identifier Type: -
Identifier Source: org_study_id
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