IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06703567
• Lead Sponsor: European Institute of Oncology

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.

Detailed Description

Advances made in our understanding of the molecular biology of breast cancer have improved diagnostic testing and therapeutic options available to patients. Importantly results from genomic testing provide more accurate tailoring of treatments potentially enhancing the benefit to harm ratio by only offering adjuvant chemotherapy to those patients at highest risk of recurrence, and sparing those at lower risk the unwanted side effects of cytotoxic treatment. Conversations about risks and optimal treatments can be complex.

To aid understanding about GEP tests many clinical teams provide patients with information leaflets about GEP testing. Unfortunately these are often written by either academic or commercial sponsors and designed to meet certain ethical and regulatory guidelines rather than effectively educate the end-user.

There is some evidence that user-friendly patient information films might enhance patient knowledge and understanding and are more accessible to certain individuals, especially those with low literacy.

IMPARTER project has developed eight-minute film explaining why Oncotype DX GEP tests is used in EBC, what it is, and how the results help determine whether or not chemotherapy is recommended as a useful treatment option.

This study wish to examine the utility of the information film in the clinic setting with EBC patients identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.

Study Timeline

• Study Start: 2024-09-06
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
GEP Knowledge Evaluation	1 week	Collection of Gene Expression Profiling (GEP) Knowledge Questionnaire (higher total score indicates better understanding)

Secondary Outcome Measures

Name	Time	Method
Anxiety assessment	1 week	Collection of Spielberger State/Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)
Decision making assessment	1 week	Collection of Decisional Conflict Scale questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
Reaction to uncertain situations assessment	1 week	Collection of Intolerance of Uncertainty Scale Short-Form (IUS-12) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
Physician confidence/satisfaction assessment	1 week	Collection of Confidence/satisfaction with GEP test result discussions questionnaire (higher scores indicate better satisfaction)

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy