Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01)

NCT07578415 | Not Yet Recruiting

• 1 other identifier: 160/2023
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Breast Cancer; HER2 Negative Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Study Arms (4)

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.

Interventions

Shared Decision Making (SDM) Support Program BEHAVIORAL

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.

Patient Only Educated; Physician Only Trained; Physician and Patient Trained

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

SDM

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-04