Clinical trial NCT06703567: IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4
Official title: IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Early breast cancer
Gene Expression Profiling
Oncotype DX
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: GEP Knowledge Evaluation
timeFrame: 1 week
Secondary outcomes:
measure: Anxiety assessment
timeFrame: 1 week
measure: Decision making assessment
timeFrame: 1 week
measure: Reaction to uncertain situations assessment
timeFrame: 1 week
measure: Physician confidence/satisfaction assessment
timeFrame: 1 week
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Istitute of Oncology
name: Gabriella Pravettoni, MD
role: PRINCIPAL_INVESTIGATOR
References: