Breast CancerSDM-01NCT07578415
Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01)
A study testing Shared Decision Making (SDM) Support Program in people with Breast Cancer and HER2 Negative Breast Cancer, run by Federico II University.
Trial summary
Background and Purpose: Deciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, HER2 Negative Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Shared Decision Making (SDM) Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jan 2029
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of metastatic breast cancer (MBC).
- HER2-negative status (as per ASCO/CAP guidelines).
- Patients scheduled to receive or currently receiving their first-line therapy for metastatic disease.
- Age ≥ 18 years.
- Willingness to participate in the study and provide written informed consent.
Who cannot join
- Diagnosis of early-stage breast cancer (non-metastatic).
- HER2-positive metastatic breast cancer.
- Age < 18 years.
- Refusal to sign the study-specific informed consent form.
About this study
Official title: Implementing Shared Decision Making (SDM) For HER2 Negative Metastatic Breast Cancer Patients (SDM-01 Study)
Background and Purpose:
Deciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life. Shared Decision Making (SDM) is a communication process where doctors and patients work together to make healthcare choices. This study aims to evaluate whether providing specific SDM training to oncologists and educational materials to patients can improve the quality of these conversations and make the treatment process feel more focused on patient goals.
Read more
Study Design and Procedures:
This is a prospective, randomized multicenter study involving oncology centers in Italy. A total of 120 patients starting their first-line therapy for HER2-negative metastatic breast cancer will participate. Participants and their oncologists will be assigned to one of two main study arms:
The SDM Trained Group: This group includes different approaches, such as formal SDM training for oncologists, providing educational materials (booklet and video) to patients, or a combination of both.
The Usual Care Group: In this group, patients and oncologists follow standard care processes without specific SDM training or additional educational materials.
What to Expect:
Patients in all groups will be asked to complete standardized questionnaires (such as CollaboRATE, SURE, and SDM-Q-9) at two time points: on Day 1 after the first encounter with the oncologist and at a 6-month follow-up. These surveys will measure the patient's perception of the decision-making process, their satisfaction with the treatment choice, and their overall quality of life.
Goal:
The researchers hypothesize that educational training for patients and/or physicians will improve the quality of conversations about MBC therapy. If successful, this study may provide tools to enhance patient adherence to treatment and overall well-being.
- Being tested
- Shared Decision Making (SDM) Support Program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision Making (SDM) Support ProgramBehavioural
Comprehensive Shared Decision Making (SDM) program. No drug treatment will be administered in this study. The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice. Depending on the assigned study arm, participants may receive one, both, or neither of these components.
| Study group | Role | What they receive |
|---|---|---|
| Physician and Patient Trained | Experimental | Not described Receives: Behavioral: Shared Decision Making (SDM) Support Program |
| Physician Only Trained | Experimental | Not described Receives: Behavioral: Shared Decision Making (SDM) Support Program |
| Patient Only Educated | Experimental | Not described Receives: Behavioral: Shared Decision Making (SDM) Support Program |
| Usual Care | No intervention | Patients and oncologists follow standard care processes. No specific training on Shared Decision Making (SDM) is provided to the oncologist, and no additional educational materials are given to the patient. Both parties will only complete the study questionnaires to evaluate the baseline quality of decision-making. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDM-Q-9 (9-item Shared Decision Making Questionnaire)
A 9-item scale used to measure the level of shared decision-making from the patient's perspective. Each item is scored on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree). The total score is transformed to a scale of 0 to 100, where higher scores indicate a higher level of involvement in the decision-making process.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (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 Federico II UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grazia Arpino, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578415
- Sponsor's protocol ID
- 160/2023
- Acronym
- SDM-01
- Status last verified
- Apr 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Shared Decision Making (SDM) For HER2 Negative Metastatic Breast Cancer Patients (SDM-01 Study)
- ClinicalTrials.gov ID
- NCT07578415
- Acronym / sponsor ID
- SDM-01 / 160/2023
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 11 May 2026 (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.
Background and Purpose:
Deciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life. Shared Decision Making (SDM) is a communication process where doctors and patients work together to make healthcare choices. This study aims to evaluate whether providing specific SDM training to oncologists and educational materials to patients can improve the quality of these conversations and make the treatment process feel more focused on patient goals.
Study Design and Procedures:
This is a prospective, randomized multicenter study involving oncology centers in Italy. A total of 120 patients starting their first-line therapy for HER2-negative metastatic breast cancer will participate. Participants and their oncologists will be assigned to one of two main study arms:
The SDM Trained Group: This group includes different approaches, such as formal SDM training for oncologists, providing educational materials (booklet and video) to patients, or a combination of both.
The Usual Care Group: In this group, patients and oncologists follow standard care processes without specific SDM training or additional educational materials.
What to Expect:
Patients in all groups will be asked to complete standardized questionnaires (such as CollaboRATE, SURE, and SDM-Q-9) at two time points: on Day 1 after the first encounter with the oncologist and at a 6-month follow-up. These surveys will measure the patient's perception of the decision-making process, their satisfaction with the treatment choice, and their overall quality of life.
Goal:
The researchers hypothesize that educational training for patients and/or physicians will improve the quality of conversations about MBC therapy. If successful, this study may provide tools to enhance patient adherence to treatment and overall well-being.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physician and Patient Trained | Experimental | Behavioral: Shared Decision Making (SDM) Support Program |
| Physician Only Trained | Experimental | Behavioral: Shared Decision Making (SDM) Support Program |
| Patient Only Educated | Experimental | Behavioral: Shared Decision Making (SDM) Support Program |
| Usual Care | No intervention | –Patients and oncologists follow standard care processes. No specific training on Shared Decision Making (SDM) is provided to the oncologist, and no additional educational materials are given to the patient. Both parties will only complete the study questionnaires to evaluate the baseline quality of decision-making. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of metastatic breast cancer (MBC).
- HER2-negative status (as per ASCO/CAP guidelines).
- Patients scheduled to receive or currently receiving their first-line therapy for metastatic disease.
- Age ≥ 18 years.
- Willingness to participate in the study and provide written informed consent.
Key exclusion criteria (4 listed)
- Diagnosis of early-stage breast cancer (non-metastatic).
- HER2-positive metastatic breast cancer.
- Age < 18 years.
- Refusal to sign the study-specific informed consent form.
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 |
|---|---|---|
| Shared Decision Making (SDM) Support ProgramComprehensive Shared Decision Making (SDM) program. No drug treatment will be administered in this study. The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice. Depending on the assigned study arm, participants may receive one, both, or neither of these components. | Behavioural | Patient Only Educated, Physician Only Trained, Physician and Patient Trained |
Primary outcome
SDM-Q-9 (9-item Shared Decision Making Questionnaire)
Time frame: Baseline and 6 months
A 9-item scale used to measure the level of shared decision-making from the patient's perspective. Each item is scored on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree). The total score is transformed to a scale of 0 to 100, where higher scores indicate a higher level of involvement in the decision-making process.
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 11 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making (SDM) Support Program in people with Breast Cancer and HER2 Negative Breast Cancer, run by Federico II University.
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: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDM-Q-9 (9-item Shared Decision Making Questionnaire) (time frame: Baseline and 6 months). 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 11 May 2026.