Actively Recruiting

Age: 18Years +
All Genders
ID06762496

Development and Testing of a Patient Decision Aid to Support Women with Early-Stage Breast Cancer in Treatment Decisions

Led by European Institute of Oncology · Updated on 2025-11-28

180

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 18 years old or older
  • 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
Not Eligible

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

AI-Screening

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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

Trial Site Locations

Total: 1 location

1

European Institute of Oncology

Milan, Italy, Italy, 20141

Actively Recruiting

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Research Team

G

Gabriella Pravettoni

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.

Serena Sdinami, Valeria Sebri, Dario Monzani...

https://pubmed.ncbi.nlm.nih.gov/41734922