IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4 (IMPARTER)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
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
-
-
-
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
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard
GEP test information (as per standard hospital policy)
|
Patients will receive information about the GEP test by clinical teams
|
|
Experimental: GEP film
Standard policy + the relevant 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
Time Frame: 1 week
|
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
Time Frame: 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)
|
1 week
|
|
Anxiety assessment
Time Frame: 1 week
|
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
Time Frame: 1 week
|
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
Time Frame: 1 week
|
Collection of Confidence/satisfaction with GEP test result discussions questionnaire (higher scores indicate better satisfaction)
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriella Pravettoni, MD, European Istitute of Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IEO 1924
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.