Breast CarcinomaNCT06762496
A New Tool to Promote Patient's Engagement in Their Healthcare Process
An observational study of Breast Carcinoma and Breast Cancer Stage I, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Women diagnosed with early-stage breast cancer need to make a decision about the therapeutic treatment to undertake. Since multiple factors can influence this decision, it is necessary to develop a decision-making support tool to assist them in making this choice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Breast Cancer Stage I, Breast Cancer Stage II
- What is being tested?
- Healthcare professionals and Patients PDA group
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jan 2025to Jan 2027
- Phase
- Observational
- 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
Study population: Number of healthcare professionals (HCPs) targeted, including team members: we will involve 30 physicians (who are involved in the process of care towards patients with early breast cancer (10 oncologists, 10 breast surgeon, and 10 breast radiologists specifically) for the semi-structured interviews. Moreover, about 10-12 professionals will take part in the steering committee. Number of Patients affected: we will involve patients with early breast cancer for a total of 170 participants, considering all phases of the present project.
Who may be able to join
- be 18 or older;
- have received/receive diagnosis of resectable breast cancer in the early stage;
- women treated or who will undergo oncological treatment for early breast cancer;
- demonstrate the absence of psychopathological features.
- be willing and able to provide written informed consent/assent for the trial
Who cannot join
- breast cancer patients who showed physical or psychological issues, as well as cognitive impairments that prohibited their participation in this type of study;
- neurological or psychiatric disorders that may compromise the patients' ability to take part in the study.
- Distant metastases from breast cancer or locally advanced/unresectable disease
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
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, Italy, 20141
About this study
Official title: Development and Testing of a Patient's Decision Aid for Early Breast Cancer: a New Tool to Promote Patient's Engagement in Their Healthcare Process
Women diagnosed with early-stage breast cancer need to make a decision about the therapeutic treatment to undertake. Since multiple factors can influence this decision, it is necessary to develop a decision-making support tool to assist them in making this choice.
Main Objective: To develop a decision-making support tool for determining the treatment to undertake for women diagnosed with early-stage breast cancer and test its effectiveness on an experimental group.
Read the detailed description
Women with any type of early breast cancer (0-2A stages) will be recruited at Istituto Europeo di Oncologia (IEO). 170 patients with early breast cancer and 30 clinicians involved in the present project will directly benefit from better-provided care, an increase in patients' knowledge and management of their oncological symptoms, an improved patient-and-doctor relationship, and a reduction of hospital economic costs.
Our interdisciplinary team will include breast cancer patients, oncologists, surgeons, psychologists, radiologists, , and nurses. All members of our team will play an active role in the most important phases of our data-driven project development cycle. A patient-centered approach will allow us to ensure their active participation from the design phase to the dissemination phase of the project.
This present research project will be based on two different prospective studies: a first study based on patients already treated for breast cancer and a second study with patients newly diagnosed with early breast cancer.
Semi structured interviews will be used in the first study, while newly diagnosed women in the second study will be asked to fill in an online battery of questionnaires in three different times (T0: one week after the first consultation; T1: a month later the first medical consultation; T2: three months later the first medical consultation) to assess the possible impact of using the Patient Decision Aids (PDA) on the doctor-patient communication and shared decision-making (SDM) process.
This project will follow a multi-step approach and will be therefore divided into different developmental phases, within which specific objectives will need to be reached in order to move forward.
Assessment measures throughout the protocol include: AttrakDiff; SUS, a 38-item specific questionnaire that measures satsifaction with PDA, PHQ-9, STAI, SDMQ9, Distress thermometer, EORTC-QLQ.C30, EORT-QLQ-BR23. Any further material used for qualitative assessment will be be made available upon reasonable request.
- Being tested
- Healthcare professionals, Patients PDA group, Patients control group
- Keywords
- early breast cancer, Patient Decision, engagement
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthcare professionalsOther
healthcare professionals (HCPs) targeted, including team members: we will involve 30 physicians (who are involved in the process of care towards patients with early breast cancer (10 oncologists, 10 breast surgeon, and 10 breast radiologists specifically) for the semi-structured interviews
Patients PDA groupOther
Participants will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires
Patients control groupOther
Participants will receive only the online link with the battery of questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Stakeholders | physicians involved in the diagnosis and treatment decision for patients with early breast cancer (10 oncologists, 10 breast surgeons, and 10 breast radiologists specifically). Receives: Other: Healthcare professionals | |
| Patients PDA group | Participants randomized in this group will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires Receives: Other: Patients PDA group | |
| Patients control group | Patients randomized in this group will receive only the online link with the battery of questionnaires. Receives: Other: Patients control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of an ad hoc Patient Decision Aid (PDA)
Patients in the Intervention group will receive via mail the final version of the PDA and a battery of questionnaires.
Patients in the Control group will receive only the online link with the battery of questionnaires.
In both the experimental and the control group, questionnaires will be administered one week after the first medical consultation (T0), one month later the first medical consultation (T1), and three months later the first medical consultations (T2).
The difference between T1 and T0 and T2 and T0 will be calculated for each endpoint.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start22 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762496
- Sponsor's protocol ID
- UID 4841
- Status last verified
- Nov 2024
- First submitted
- 31 Dec 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dissemination of results will follow typical academic pathways, such as conference abstracts and peer-reviewed journals
Publications
Sdinami S, Maialetti M, Sebri V, Zagami P, Grasso R, Curigliano G, Pravettoni G. From Clinical Reality to Blueprint Designing: A Qualitative Study Exploring Communication Challenges and Unmet Needs for Patient Decision Aid Development in Early-Stage Breast Cancer. Psychooncology. 2026 Oct;35(10):e70622. doi: 10.1002/pon.70622.
PubMed 42831611Sdinami S, Sebri V, Monzani D, Zagami P, Criscitiello C, Grasso R, Bagnardi V, Curigliano G, Pravettoni G. Protocol for the development and testing of a web-based patient decision aid for early-stage breast cancer patients within a cancer centre care: a mixed-method approach. BMJ Open. 2026 Feb 24;16(2):e107401. doi: 10.1136/bmjopen-2025-107401.
PubMed 41734922
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Patient's Decision Aid for Early Breast Cancer: a New Tool to Promote Patient's Engagement in Their Healthcare Process
- ClinicalTrials.gov ID
- NCT06762496
- Acronym / sponsor ID
- UID 4841
- Keywords
- early breast cancer, Patient Decision, engagement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Jan 2025 (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.
Women diagnosed with early-stage breast cancer need to make a decision about the therapeutic treatment to undertake. Since multiple factors can influence this decision, it is necessary to develop a decision-making support tool to assist them in making this choice.
Main Objective: To develop a decision-making support tool for determining the treatment to undertake for women diagnosed with early-stage breast cancer and test its effectiveness on an experimental group.
Detailed description
Women with any type of early breast cancer (0-2A stages) will be recruited at Istituto Europeo di Oncologia (IEO). 170 patients with early breast cancer and 30 clinicians involved in the present project will directly benefit from better-provided care, an increase in patients' knowledge and management of their oncological symptoms, an improved patient-and-doctor relationship, and a reduction of hospital economic costs.
Our interdisciplinary team will include breast cancer patients, oncologists, surgeons, psychologists, radiologists, , and nurses. All members of our team will play an active role in the most important phases of our data-driven project development cycle. A patient-centered approach will allow us to ensure their active participation from the design phase to the dissemination phase of the project.
This present research project will be based on two different prospective studies: a first study based on patients already treated for breast cancer and a second study with patients newly diagnosed with early breast cancer.
Semi structured interviews will be used in the first study, while newly diagnosed women in the second study will be asked to fill in an online battery of questionnaires in three different times (T0: one week after the first consultation; T1: a month later the first medical consultation; T2: three months later the first medical consultation) to assess the possible impact of using the Patient Decision Aids (PDA) on the doctor-patient communication and shared decision-making (SDM) process.
This project will follow a multi-step approach and will be therefore divided into different developmental phases, within which specific objectives will need to be reached in order to move forward.
Assessment measures throughout the protocol include: AttrakDiff; SUS, a 38-item specific questionnaire that measures satsifaction with PDA, PHQ-9, STAI, SDMQ9, Distress thermometer, EORTC-QLQ.C30, EORT-QLQ-BR23. Any further material used for qualitative assessment will be be made available upon reasonable request.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stakeholders | – | Other: Healthcare professionalsphysicians involved in the diagnosis and treatment decision for patients with early breast cancer (10 oncologists, 10 breast surgeons, and 10 breast radiologists specifically). |
| Patients PDA group | – | Other: Patients PDA groupParticipants randomized in this group will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires |
| Patients control group | – | Other: Patients control groupPatients randomized in this group will receive only the online link with the battery of questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Number of healthcare professionals (HCPs) targeted, including team members: we will involve 30 physicians (who are involved in the process of care towards patients with early breast cancer (10 oncologists, 10 breast surgeon, and 10 breast radiologists specifically) for the semi-structured interviews. Moreover, about 10-12 professionals will take part in the steering committee. Number of Patients affected: we will involve patients with early breast cancer for a total of 170 participants, considering all phases of the present project.
Key inclusion criteria (5 listed)
- be 18 or older;
- have received/receive diagnosis of resectable breast cancer in the early stage;
- women treated or who will undergo oncological treatment for early breast cancer;
- demonstrate the absence of psychopathological features.
- be willing and able to provide written informed consent/assent for the trial
Key exclusion criteria (4 listed)
- breast cancer patients who showed physical or psychological issues, as well as cognitive impairments that prohibited their participation in this type of study;
- neurological or psychiatric disorders that may compromise the patients' ability to take part in the study.
- Distant metastases from breast cancer or locally advanced/unresectable disease
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
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 |
|---|---|---|
| Healthcare professionalshealthcare professionals (HCPs) targeted, including team members: we will involve 30 physicians (who are involved in the process of care towards patients with early breast cancer (10 oncologists, 10 breast surgeon, and 10 breast radiologists specifically) for the semi-structured interviews | Other | Stakeholders |
| Patients PDA groupParticipants will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires | Other | Patients PDA group |
| Patients control groupParticipants will receive only the online link with the battery of questionnaires | Other | Patients control group |
Primary outcome
Development of an ad hoc Patient Decision Aid (PDA)
Time frame: 3 months
Patients in the Intervention group will receive via mail the final version of the PDA and a battery of questionnaires. Patients in the Control group will receive only the online link with the battery of questionnaires. In both the experimental and the control group, questionnaires will be administered one week after the first medical consultation (T0), one month later the first medical consultation (T1), and three months later the first medical consultations (T2). The difference between T1 and T0 and T2 and T0 will be calculated for each endpoint.
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 28 Nov 2025.
- Derived from this study: PubMed 42831611Sdinami S, Maialetti M, Sebri V, Zagami P, Grasso R, Curigliano G, Pravettoni G. From Clinical Reality to Blueprint Designing: A Qualitative Study Exploring Communication Challenges and Unmet Needs for Patient Decision Aid Development in Early-Stage Breast Cancer. Psychooncology. 2026 Oct;35(10):e70622. doi: 10.1002/pon.70622.
- Derived from this study: PubMed 41734922Sdinami S, Sebri V, Monzani D, Zagami P, Criscitiello C, Grasso R, Bagnardi V, Curigliano G, Pravettoni G. Protocol for the development and testing of a web-based patient decision aid for early-stage breast cancer patients within a cancer centre care: a mixed-method approach. BMJ Open. 2026 Feb 24;16(2):e107401. doi: 10.1136/bmjopen-2025-107401.
- Individual participant dataSharing planned: Yes. Dissemination of results will follow typical academic pathways, such as conference abstracts and peer-reviewed journals
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Breast Cancer Stage I, 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 5 inclusion and 4 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 28 Nov 2025. 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 (0039 02 57489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of an ad hoc Patient Decision Aid (PDA) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06762496, which also lists 2 linked publications.
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 28 Nov 2025.