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IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4

NCT ID: NCT06703567

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-06

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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Early breast cancer Gene Expression Profiling Oncotype DX

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard

GEP test information (as per standard hospital policy)

Group Type ACTIVE_COMPARATOR

Standard Policy

Intervention Type BEHAVIORAL

Patients will receive information about the GEP test by clinical teams

GEP film

Standard policy + the relevant GEP information film

Group Type EXPERIMENTAL

Standard Policy + GEP Information Film

Intervention Type 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

Interventions

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Standard Policy

Patients will receive information about the GEP test by clinical teams

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriella Pravettoni, MD

Role: PRINCIPAL_INVESTIGATOR

European Istitute of Oncology

Locations

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European Institute of Oncology

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gabriella Pravettoni, MD

Role: CONTACT

Phone: +39 0257489731

Email: [email protected]

Mara Negri

Role: CONTACT

Phone: +39 0257489536

Email: [email protected]

Facility Contacts

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Gabriella Pravettoni, MD

Role: primary

Other Identifiers

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IEO 1924

Identifier Type: -

Identifier Source: org_study_id