IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4

Overview

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.

Interventions

• Behavioral Standard Policy
  Patients will receive information about the GEP test by clinical teams
• Behavioral Standard Policy + GEP Information Film
  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

Primary outcome measures

• GEP Knowledge Evaluation [Time frame: 1 week]

Secondary outcome measures (4)

• Anxiety assessment [Time frame: 1 week]
• Decision making assessment [Time frame: 1 week]
• Reaction to uncertain situations assessment [Time frame: 1 week]
• Physician confidence/satisfaction assessment [Time frame: 1 week]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Italy · 1 center

• European Institute of Oncology — Milan

Identifiers

NCT: NCT06703567 · IEO 1924

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗