Clinical trial · Interventional
IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4
NCT06703567CI-TRIAL-00083533IMPARTERrecruitingN/AClinicalTrials.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 primary aim of the study is to determine if provision of a patient information film about Oncotype DX improves patients' knowledge and understanding about Gene Expression Profiling (GEP) test and risk of recurrence results in early breast cancer (EBC) patients, identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Policy | Behavioral | — | UNRESOLVED |
| Standard Policy + GEP Information Film | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard
- description
- GEP test information (as per standard hospital policy)
- interventionNames
- Behavioral: Standard Policy
- type
- EXPERIMENTAL
- label
- GEP film
- description
- Standard policy + the relevant GEP information film
- interventionNames
- Behavioral: Standard Policy + GEP Information Film
Primary outcomes (1)
- measure
- GEP Knowledge Evaluation
- timeFrame
- 1 week
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * First presentation of early stage breast cancer with all known disease surgically removed * Estrogen Receptor (ER) positive and Human Epidermal growth factor Receptor 2 (HER-2) negative * No clear decision on whether chemotherapy should be given as adjunct based on current prognostic criteria * Consented to GEP testing * Able to give full informed consent to IMPARTER study * Good comprehension of the Italian language * Access to internet connection and devices (e.g. smart phone, tablet, laptop or desktop computer) Exclusion Criteria: * Other breast cancer diagnosis (e.g. Ductal carcinoma in situ, Metastatic) * Unable to give fully informed consent * Under 18 years of age * Unable to understand and speak Italian * No access to internet connection or devices
References
Publications (0)
Data not yet available
No reference posted for this study.