Clinical trial · Observational
New Model for Integrating Person-based Care (PbC) in the Treatment of Advanced HER2-negative Breast Cancer
New Model for Integrating Person-based Care (PbC) in the Treatment of Advanced HER2-negative Breast Cancer: InPerson Study
- 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 emerging paradigm of person-centered medicine has resulted in a change in the approach and management of health needs, and the introduction of new models and tools into clinical practice. One important change is the introduction of quality of life measurement (HRQoL). The tools used, however, remain anchored in a purely quantitative model, which does not enter the person's specific identity and emotional territory. The perception of quality of life is highly subjective, anchored in each person's needs and expectations (relative deprivation). The structured integration of the patient's point of view can be strengthened by the introduction of narrative medicine and qualitative methodologies, which enrich the point of view expressed in a standardized way, favoring person-centered care and not categories of patients. The National Chronicity Plan (2016) promotes the application of narrative medicine in clinical practice, aiming at the personalization of care: "the patient-person and his or her individual 'global' health project built through a personalized and shared 'Care Pact' that considers not only his or her clinical condition, but also the life context in which the disease is experienced". The current spread of digital tools in health care can facilitate the integration of qualitative and quantitative components through the use of dedicated platforms. In breast cancer patients with advanced disease, especially with triple-negative and HER2-negative biological subtype, oncological treatments include chemotherapy regimens, without or with target therapies and biological treatments combined with endocrinotherapy. For these patients, there is a need to improve treatment-related outcomes and overall quality of care and quality of life. To date, there is a lack of detection of subjective experience on an ongoing basis, which is the basis for personalization of care, and which may also have an impact on adherence to cancer treatment. The study aims to evaluate the introduction of the digital Person based Care (PbC) model designed by the project team. The model uses an online platform to integrate HRQoL quantitative data and qualitative narrative data for personalized care pathway based on the daily needs and existential project of the patient/caregiver.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sharing all key aspects associated with the quality of life in a single digital environment | Other | — | 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.
- measure
- Perceived quality of life
- timeFrame
- 12 months
- description
- The improvement of perceived quality of life for patients with advanced breast cancer.
- measure
- Personalization of care pathway
- timeFrame
- 12 months
- description
- The personalization of the care pathway with integrative therapies, based on the patients' needs, attitudes and lifestyles.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient able to understand, sign and date the informed consent prior to any specific study procedure; * Diagnosis of HER2-negative advanced breast cancer (ER and PgR hormone receptor negative or ER and/or PgR receptor positive), undergoing cancer treatment * Age ≥18 years * Knowledge of the Italian language * Life expectancy ≥ 24 weeks * Basic level of digital knowledge. Exclusion Criteria: * Inability to participate in the patient's study (psychiatric disorders, PS ECOG \> 2) and unavailability of caregiver; * Unavailability of an e-mail account or unavailability to use web-based tools (for the patient/caregiver); * Patients who do not sign informed consent.
References
Publications (1)
- DERIVEDFabi A, Rossi A, Mocini E, Cardinali L, Bonavolonta V, Cenci C, Magno S, Barberi V, Moretti A, Besharat ZM, Iolascon G, Baldari C, Ferretti E, Botticelli A, Paris I, Scambia G, Migliaccio S. An Integrated Care Approach to Improve Well-Being in Breast Cancer Patients. Curr Oncol Rep. 2024 Apr;26(4):346-358. doi: 10.1007/s11912-024-01500-1. Epub 2024 Feb 24. PMID 38400984