Breast CancerIMPARTERNCT06703567
IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4
A study testing Standard Policy and Standard Policy + GEP Information Film in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard Policy and Standard Policy + GEP Information Film
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 6 Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Gabriella Pravettoni, MD, +39 0257489731, gabriella.pravettoni@ieo.it
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Standard Policy, Standard Policy + GEP Information Film
- Keywords
- Early breast cancer, Gene Expression Profiling, Oncotype DX
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PolicyBehavioural
Patients will receive information about the GEP test by clinical teams
Standard Policy + GEP Information FilmBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | GEP test information (as per standard hospital policy) Receives: Behavioral: Standard Policy |
| GEP film | Experimental | Standard policy + the relevant GEP information film Receives: Behavioral: Standard Policy + GEP Information Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
GEP Knowledge Evaluation
Collection of Gene Expression Profiling (GEP) Knowledge Questionnaire (higher total score indicates better understanding)
Measured: 1 week
Secondary outcomes (4)
Anxiety assessment
Collection of Spielberger State/Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)
Measured: 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)
Measured: 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)
Measured: 1 week
Physician confidence/satisfaction assessment
Collection of Confidence/satisfaction with GEP test result discussions questionnaire (higher scores indicate better satisfaction)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start6 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, MD, Principal investigator, European Istitute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703567
- Sponsor's protocol ID
- IEO 1924
- Acronym
- IMPARTER
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4
- ClinicalTrials.gov ID
- NCT06703567
- Acronym / sponsor ID
- IMPARTER / IEO 1924
- Conditions
- Breast Cancer
- Keywords
- Early breast cancer, Gene Expression Profiling, Oncotype DX
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Behavioral: Standard PolicyGEP test information (as per standard hospital policy) |
| GEP film | Experimental | Behavioral: Standard Policy + GEP Information FilmStandard policy + the relevant GEP information film |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard PolicyPatients will receive information about the GEP test by clinical teams | Behavioural | Standard |
| Standard Policy + GEP Information FilmPatients 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 | Behavioural | GEP film |
Primary outcome
GEP Knowledge Evaluation
Time frame: 1 week
Collection of Gene Expression Profiling (GEP) Knowledge Questionnaire (higher total score indicates better understanding)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriella Pravettoni, MD principal investigator
European Istitute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Policy and Standard Policy + GEP Information Film in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Pravettoni, MD (+39 0257489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GEP Knowledge Evaluation (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.