Evaluating an intelligent management system for medication adherence in breast cancer treatment
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
This study is testing a new patient management system to see if it helps women with HER2-positive breast cancer stick to their medication better than usual methods while they receive pyrotinib treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 964 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | pyrotinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06958627 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of an intelligent patient management model on medication adherence among female patients with HER2-positive breast cancer receiving pyrotinib. It is a multicenter, randomized controlled study that compares this innovative approach to traditional patient management methods. The trial will include patients who are expected to undergo pyrotinib treatment for neoadjuvant therapy or metastatic breast cancer. Participants will be monitored for their ability to adhere to the medication regimen, which is crucial for treatment success.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 18 and older with histologically confirmed HER2-positive breast cancer who are expected to receive pyrotinib.
Not a fit: Patients with cognitive impairments, severe sensory disabilities, or those who have previously used pyrotinib may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve medication adherence, leading to better treatment outcomes for patients with HER2-positive breast cancer.
How similar studies have performed: While the specific approach of using an intelligent management system is novel, similar studies have shown that enhanced patient management can improve medication adherence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jiani Wang, M.D. — National Cancer Center Cancer Hospital
- Study coordinator: Jiani Wang, M.D.
- Email: ncc_wangjiani@126.com
- Phone: 86010877-88120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.