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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Jiani Wang, M.D.
- Phone Number: 86010877-88120
- Email: ncc_wangjiani@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Fei Ma
- Phone Number: 86-10-87788060
- Email: drmafei@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intelligent patient management model
|
Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
|
|
Active Comparator: traditional patient management model
|
Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
medication adherence at 1-year
Time Frame: 1-year
|
medication adherence at 1-year is assessed using the tablet counting method and Eight-Item Morisky Medication Adherence Scale Evaluation Method 1: Tablet Counting Method
At the screening phase and Day 21 of each cycle, calculate the adherence percentage based on APP check-ins, and confirm the actual remaining tablets through follow-up. Evaluation Method 2: MMAS-8 Scale （1）Definition: The Morisky Medication Adherence Scale-8 (MMAS-8) is a validated 8-item questionnaire. The total score ranges from 0 to 8, with higher scores indicating better adherence: 8: Good adherence 6-7: Moderate adherence <6: Poor adherence （2）Procedure: Administer the MMAS-8 scale at the screening phase and Day 21 of each cycle. The total score is calculated as the sum of scores from the 8 questions. |
1-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
TTD is defined as the time from randomization to confirmation of the first clinically significant deterioration (deterioration ≥ 10 points) in subsequent follow-up or death
|
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.
|
EFS (defined as the time from randomization to the first documentation of progressing disease while on study therapy, postoperative disease recurrence, or death from any cause)
|
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
|
the time from randomisation to death from any cause
|
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
|
EORTC QLQ-C30 and NCC-BC-A1.0 questionnaire：
|
From date of randomization until the date of death from any cause, assessed up to 4 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jiani Wang, M.D., National Cancer Center Cancer Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NCC4587
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Description: Individual participant data will not be shared to protect patient privacy. The study involves sensitive clinical and behavioral data, and even de-identified datasets carry residual re-identification risks. Data access is restricted to the research team under ethical and legal obligations.
Access Criteria: N/A IPD Sharing URL: N/A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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