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

Phase 3RecruitingNCT06958627

Cancer Institute and Hospital, Chinese Academy of Medical Sciences964 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

964

Conditions

HER2 Positive Breast Cancer Pyrotinib Treatment

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

medication adherence at 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 1. Definition/Formula: Adherence percentage = (Actual tablets taken / Total tablets prescribed) \* 100% (Actual tablets taken = Total prescribed tablets - Remaining tablets - Lost tablets) 2. Procedure: 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.

Time frame: 1-year

Secondary Outcomes

The time to deterioration (TTD)

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 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)

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)

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)

the time from randomisation to death from any cause

Time frame: From date of randomization until the date of death from any cause, assessed up to 4 years

PRO

EORTC QLQ-C30 and NCC-BC-A1.0 questionnaire： 1. Outcome Measure 1 （1）Description: Scale Full Name: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Score Range:Global Health Status/QoL Scale: 0-100. Functional Scales (e.g., Physical, Role): 0-100. Symptom Scales (e.g., Fatigue): 0-100. （2）Interpretation: Higher scores on Global Health Status/QoL and Functional Scales indicate better outcomes.Higher scores on Symptom Scales indicate worse outcomes. 2. Outcome Measure 2 （1）Description: Scale Full Name: National Cancer Center Breast Cancer-Specific Patient-Reported Outcome Scale Version 1.0 (NCC-BC-A1.0). Score Range:Total Score: 38-190 points (each item scored 1-5). （2）Interpretation:Higher total scores indicate poorer quality of life (for symptom-related items).Lower scores on positive function items (e.g., confidence, support) indicate worse outcomes. 3. Time Frame: Baseline, every 2 cycles, and at end of treatment.