NCT05893368: PERGIQUAL

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

Status unknown Last updated 24 April 2024

What this trial tests

trial testing Sharing all key aspects associated with the quality of life in a single digital environment in Advanced Breast Cancer in 50 participants. Status unknown.

Timeline

1 March 2023

Primary endpoint
1 January 2025

1 February 2025

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	50
Start date	1 March 2023
Primary completion	1 January 2025
Estimated completion	1 February 2025
Sites	1 location across Italy

Drugs / interventions tested

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

Conditions studied

• Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, female only, with Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Integrated Care Approach to Improve Well-Being in Breast Cancer Patients.
   Fabi A, Rossi A, Mocini E, Cardinali L, et al · · 2024 · cited 17× · PMID 38400984 · DOI 10.1007/s11912-024-01500-1
2. Digital integration of narrative medicine and patient-reported outcome measures to improve understanding of quality of life in metastatic breast cancer: the PERGIQUAL study.
   Fabi A, Cercato MC, Rossi A, Bianchini P, et al · · 2025 · PMID 41206065 · DOI 10.1093/oncolo/oyaf367