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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | GEP test information (as per standard hospital policy) |
|
| GEP film | Experimental | Standard policy + the relevant GEP information film |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Policy | Behavioral | Patients will receive information about the GEP test by clinical teams |
|
| Measure | Description | Time Frame |
|---|---|---|
| GEP Knowledge Evaluation | Collection of Gene Expression Profiling (GEP) Knowledge Questionnaire (higher total score indicates better understanding) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriella Pravettoni, MD | Contact | +39 0257489731 | gabriella.pravettoni@ieo.it | |
| Mara Negri | Contact | +39 0257489536 | mara.negri@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Gabriella Pravettoni, MD | European Istitute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Standard Policy + GEP Information Film | 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 |
|
Collection of Decisional Conflict Scale questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
| 1 week |
| 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 |
| Physician confidence/satisfaction assessment | Collection of Confidence/satisfaction with GEP test result discussions questionnaire (higher scores indicate better satisfaction) | 1 week |
| D017437 |
| Skin and Connective Tissue Diseases |