Clinical trial · Observational
The Performance of Patient Support Program in Early Stage Breast Cancer
A Prospective, Multicentre, Controlled, Observational Study to Evaluate the Performance of Patient Support Programme (PSP) in Improving Patient Adherence With Adjuvant Aromatase Inhibitors (AI) Medication for Postmenopausal, Early Stage Breast Cancer
NCT00769080CI-TRIAL-00005827ARI NIScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment and Standard Treatment plus PSP arm after one year
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Standard Treatment plus PSP
- label
- 2
- description
- Standard Treatment
Primary outcomes (1)
- measure
- compare the 1-year adherence
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- scores of Beliefs about Medicines Questionnaire (BMQ)
- timeFrame
- 1 year
- measure
- Scores in Patient Centred Care Questionnaire (PCCQ)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Provide signed and dated written Informed Consent * Have been taking upfront AI adjuvant therapy in line with current SmPC * Be capable of completing drug intake by herself * Be capable of understanding Chinese Exclusion Criteria: * Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has not been granted by SFDA * Upfront adjuvant AI medication which has exceeded over eight weeks * Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than AI * Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
References
Publications (1)
- DERIVEDYu KD, Zhou Y, Liu GY, Li B, He PQ, Zhang HW, Lou LH, Wang XJ, Wang S, Tang JH, Liu YH, Wang X, Jiang ZF, Ma LW, Gu L, Cao MZ, Zhang QY, Wang SM, Su FX, Zheng H, Li HY, Tang LL, Sun SR, Liu JP, Shao ZM, Shen ZZ. A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients' persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):307-13. doi: 10.1007/s10549-012-2059-8. Epub 2012 Apr 12. PMID 22527106