IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
European Institute of Oncology
RECRUITING
Milan
Contact Information
Primary
Gabriella Pravettoni, MD
gabriella.pravettoni@ieo.it
+39 0257489731
Backup
Mara Negri
mara.negri@ieo.it
+39 0257489536
Time Frame
Start Date: 2024-09-06
Estimated Completion Date: 2025-12
Participants
Target number of participants: 82
Treatments
Active_comparator: Standard
GEP test information (as per standard hospital policy)
Experimental: GEP film
Standard policy + the relevant GEP information film
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov