IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4 (IMPARTER)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Standard Policy; Behavioral: Standard Policy + GEP Information Film

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 Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mara Negri; Phone Number: +39 0257489536; Email: mara.negri@ieo.it
• Study Contact Backup: Name: Gabriella Pravettoni, MD; Phone Number: +39 0257489731; Email: gabriella.pravettoni@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • European Institute of Oncology
    • Contact: Gabriella Pravettoni, MD; Phone Number: +39 0257489731; Email: gabriella.pravettoni@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; GEP test information (as per standard hospital policy)	Behavioral: Standard Policy; Patients will receive information about the GEP test by clinical teams
Experimental: GEP film; Standard policy + the relevant GEP information film	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GEP Knowledge Evaluation	Collection of Gene Expression Profiling (GEP) Knowledge Questionnaire (higher total score indicates better understanding)	1 week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Gabriella Pravettoni, MD, European Istitute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Gene Expression Profiling; Early breast cancer; Oncotype DX
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IEO 1924

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No