Developing and Testing a Decision Support Tool
for Women with Early-Stage Breast Cancer to Enhance Patient Engagement
Led by European Institute of Oncology · Updated on 2025-11-28
180
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to develop and test a decision-making support tool to help women diagnosed with early-stage breast cancer choose their treatment. The project involves 170 patients and 30 clinicians, including oncologists, surgeons, psychologists, radiologists, and nurses, working together to improve patient knowledge, symptom management, communication with doctors, and reduce hospital costs. The study is patient-centered and includes two prospective parts one with previously treated patients and another with newly diagnosed patients.
The study includes three groups healthcare professionals participating in interviews, patients who receive the final Patient Decision Aid PDA tool and complete questionnaires, and control patients who complete questionnaires only. Newly diagnosed patients will complete questionnaires online at three time points one week, one month, and three months after their first consultation. The development and testing of the PDA tool follow a multi-step approach with specific objectives for each phase.
Participants will be assessed using various questionnaires and tools such as AttrakDiff, SUS satisfaction survey for PDA, PHQ-9, STAI, SDMQ9, Distress thermometer, and quality of life measures EORTC-QLQ.C30 and EORTC-QLQ-BR23. The study will monitor the impact of the PDA on doctor-patient communication and shared decision-making. The total study duration includes multiple assessments over three months, with qualitative and quantitative evaluations to measure outcomes and patient engagement.
CONDITIONS
Brief Title
A New Tool to Promote Patient's Engagement in Their Healthcare Process
Research Team
G
Gabriella Pravettoni
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Have a diagnosis of resectable early-stage breast cancer
Women treated or planning to undergo treatment for early breast cancer
Have no psychopathological features
Be willing and able to provide written informed consent
You will not qualify if you...
Physical or psychological issues or cognitive impairments preventing participation
Neurological or psychiatric disorders affecting ability to participate
Distant metastases or locally advanced/unresectable breast cancer
Known psychiatric or substance abuse disorders interfering with study cooperation
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility and provide consent
Diagnostic Evaluation
Duration - 1 week after the first consultation
Participants newly diagnosed with early breast cancer complete initial assessments and questionnaires to establish baseline data.
1 visit or online assessment (T0)
Monitoring
Duration - 3 months from first consultation
Participants complete follow-up questionnaires at specified intervals to evaluate the impact of the Patient Decision Aid on doctor-patient communication and decision-making.
2 online assessments at 1 month (T1) and 3 months (T2) after the first consultation
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
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.