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New Model for Integrating Person-based Care (PbC) in the Treatment of Advanced HER2-negative Breast Cancer

NCT05893368 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-04-24

No results posted yet for this study

Summary

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

Interventions

OTHER

Sharing all key aspects associated with the quality of life in a single digital environment

A digital platform called DNMLAB (DNMLAB) offers the possibility of sharing all key aspects associated with the quality of life in a single digital environment by activating: * a digital narrative diary in which the patient has the opportunity to share with the multidisciplinary team her needs, critical issues * report Patient-Reported Outcome Measures (PROMs) aimed at detecting health-related quality of life (i.e. QLQ-C30-B23 EORTC). * digital narrative diary focused on three main areas of health-related behavior-nutrition, physical activity, and sleep habits-aimed at personalizing and reshaping lifestyle, daily behaviors and, if required, the care pathway. The patient will be guided by narrative prompts, but at the same time will always be free to share all aspects related to her lifestyle that she deems useful, in addition to those detected, to benefit from a personalized care approach.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Alessandra Fabi · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-01-01
Completion
2025-02-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05893368 on ClinicalTrials.gov