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

Sponsor
Federico II University
Study ID
NCT07578415
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
May 11, 2026
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Physician and Patient Trained
  • Experimental: Physician Only Trained
  • Experimental: Patient Only Educated
  • No Intervention: Usual Care
    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.

Primary Outcome Measure

SDM-Q-9 (9-item Shared Decision Making Questionnaire) [ Time Frame: Baseline and 6 months ]

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