IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4

NCT06703567 | Recruiting

• 1 other identifier: IEO 1924
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Early breast cancer; Gene Expression Profiling; Oncotype DX

Outcome Measures

Primary Outcomes (1)

• GEP Knowledge Evaluation

  Collection of Gene Expression Profiling (GEP) Knowledge Questionnaire (higher total score indicates better understanding)

  1 week

Secondary Outcomes (4)

• Anxiety assessment

  1 week

• Decision making assessment

  1 week

• Reaction to uncertain situations assessment

  1 week

• Physician confidence/satisfaction assessment

  1 week

Study Arms (2)

Standard

ACTIVE COMPARATOR

GEP test information (as per standard hospital policy)

Behavioral: Standard Policy

GEP film

EXPERIMENTAL

Standard policy + the relevant GEP information film

Behavioral: Standard Policy + GEP Information Film

Interventions

Standard Policy BEHAVIORAL

Patients will receive information about the GEP test by clinical teams

Standard

Standard Policy + GEP Information Film BEHAVIORAL

Patients will receive information about the GEP test by clinical teams and, after consultation with physician, they will be sent a link to view the film regarding OncotypeDX

GEP film

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gabriella Pravettoni, MD

  European Istitute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni, MD

CONTACT

+39 0257489731; gabriella.pravettoni@ieo.it

Mara Negri

CONTACT

+39 0257489536; mara.negri@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: September 6, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-11

Locations

IT (1)