Improving patient understanding of Oncotype DX test results for early breast cancer
Official title: IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4
Run by European Institute of Oncology · NCT06703567 · Data updated 2026-11-12
This study tests if an eight-minute video can help early breast cancer patients better understand their Oncotype DX test results and the risks of cancer returning compared to regular information leaflets.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 82 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | September 6, 2024 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | December 10, 2024 |
| Trial ID | NCT06703567 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are early-stage breast cancer patients who are estrogen receptor positive, HER-2 negative, and have had all known disease surgically removed.
✕Probably not a fit
Patients with other breast cancer diagnoses, those unable to provide informed consent, or those who do not speak Italian may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate whether an eight-minute patient information film about the Oncotype DX Gene Expression Profiling (GEP) test enhances understanding and knowledge among early breast cancer patients regarding their test results and recurrence risks. The film is designed to be more accessible than traditional information leaflets, which may not effectively educate patients. Participants will be early-stage breast cancer patients who have had their tumors surgically removed and are uncertain about the need for chemotherapy. The study will compare the standard information provision with the film intervention to assess its impact on patient comprehension.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient understanding of their treatment options and risks, leading to more informed decision-making.
How similar studies have gone: There is some evidence that user-friendly information films can enhance patient understanding, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
European Institute of Oncology
Milan, Italy Recruiting
Study contacts
- Principal investigator: Gabriella Pravettoni, MD — European Istitute of Oncology
- Study coordinator: Gabriella Pravettoni, MD
- Email: gabriella.pravettoni@ieo.it
- Phone: +39 0257489731
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.