Clinical trial · Observational
New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer
Application of a New Digital Person-based Care (PbC) Model for the Treatment of Patients With HER2-negative Advanced Breast Cancer
- 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)
The goal of the InPerson study is to employ all resources in a digital listening platform to benefit the quality of life of patients (QoL) with advanced HER2-negative breast cancer. The care pathway of patients with this type of disease represents an optimal setting for the implementation of an innovative narrative medicine pathway that, aided by integrative therapies, aims to support and accompain them in their treatment journey with a continuum of care. Moreover, the narrative medicine platform will implement the actual "static" way to define QoL with the classic Patient-Reported Outcomes (PROs) questionnaires, that reflect the patient status at a certain time point and not as a dinamic entity. It is on the basis of these assumptions that the present application project on the use of the DNMLAB digital narrative diary in the oncology department of the Fondazione Policlinico Gemelli was born.
Conditions
Conditions (4)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Narrative Medicine | — | UNRESOLVED | — |
| Patient Satisfaction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| introduction of digital listening may improve the quality of life of patients withe breast cancer | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Standardized quality-of-life measurement
- timeFrame
- 12 months
- description
- The integration of standardized quality-of-life measurement with the patient's subjective narrative through the application of validated narrative medicine methodologies. Primarily QoL questionnaires from EORTC QLQC-30 and QLQ-BR23, implemented with digital narrative tehniques.
- measure
- Perceived quality of life
- timeFrame
- 12 months
- description
- The improvement of the perceived quality of life of patients with advanced breast cancer,Primarily QoL questionnaires from EORTC QLQC-30 and QLQ-BR23, implemented with digital narrative tehniques.
- measure
- Personalization of the care pathway
- timeFrame
- 12 months
- description
- Personalization of the care pathway through integrative therapies, based on patients' needs, attitudes and lifestyles. This does not necessarily need standardized questionnaires, because if the patient raise concern about a sign or symptom, this will be properly evaluated with the last CTCAE available version.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HER2-negative advanced disease undergoing first- or second-line oncological treatment combined with integrative therapies; * Age ≥18 years; * Knowledge of Italian language; * Life expectancy ≥24 weeks. In case the patient is unable to actively participate, the caregiver can act as a vicarious narrator and contribute to the study by supplementing the patient's contribution. Exclusion Criteria: * ECOG Performance Status \>2; * Inability to participate in the study due to psychiatric disorders; * Unavailability of an e-mail account or unwillingness to use web-based tools.
References
Publications (0)
Data not yet available