Clinical trial · Observational
A New Tool to Promote Patient's Engagement in Their Healthcare Process
Development and Testing of a Patient's Decision Aid for Early Breast Cancer: a New Tool to Promote Patient's Engagement in Their Healthcare Process
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Women diagnosed with early-stage breast cancer need to make a decision about the therapeutic treatment to undertake. Since multiple factors can influence this decision, it is necessary to develop a decision-making support tool to assist them in making this choice. Main Objective: To develop a decision-making support tool for determining the treatment to undertake for women diagnosed with early-stage breast cancer and test its effectiveness on an experimental group.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healthcare professionals | Other | — | UNRESOLVED |
| Patients control group | Other | — | UNRESOLVED |
| Patients PDA group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Stakeholders
- description
- physicians involved in the diagnosis and treatment decision for patients with early breast cancer (10 oncologists, 10 breast surgeons, and 10 breast radiologists specifically).
- interventionNames
- Other: Healthcare professionals
- label
- Patients PDA group
- description
- Participants randomized in this group will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires
- interventionNames
- Other: Patients PDA group
- label
- Patients control group
- description
- Patients randomized in this group will receive only the online link with the battery of questionnaires.
- interventionNames
- Other: Patients control group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * be 18 or older; * have received/receive diagnosis of resectable breast cancer in the early stage; * women treated or who will undergo oncological treatment for early breast cancer; * demonstrate the absence of psychopathological features. * be willing and able to provide written informed consent/assent for the trial Exclusion Criteria: * breast cancer patients who showed physical or psychological issues, as well as cognitive impairments that prohibited their participation in this type of study; * neurological or psychiatric disorders that may compromise the patients' ability to take part in the study. * Distant metastases from breast cancer or locally advanced/unresectable disease * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
References
Publications (1)
- DERIVEDSdinami S, Sebri V, Monzani D, Zagami P, Criscitiello C, Grasso R, Bagnardi V, Curigliano G, Pravettoni G. 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. BMJ Open. 2026 Feb 24;16(2):e107401. doi: 10.1136/bmjopen-2025-107401. PMID 41734922