Clinical trial NCT05893368: New Model for Integrating Person-based Care (PbC) in the Treatment of Advanced HER2-negative Breast Cancer
Official title: New Model for Integrating Person-based Care (PbC) in the Treatment of Advanced HER2-negative Breast Cancer: InPerson Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Breast Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with HER2-negative advanced breast cancer (IHC score 0, 1+, or 2+ with non-amplified FISH/SISH) on 1st or 2nd line treatment, with advanced disease, under oncological treatment.

Brief 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.

Detailed description: The healthcare system has undergone significant changes with the emergence of a person-centered medicine paradigm. Nowadays, care pathways are evaluated not only based on clinical results, but also on their impact on patients' quality of life. With the medical and therapeutic advancements in healthcare, the need for more integrated, empathic, and person-centered clinical approaches that consider the needs and expectations of patients is growing.

Clinical practice has introduced new measurement tools to capture the patient's perspective on the outcomes of care pathways, including Patient-Reported Outcome Measures (PROMs) aimed at evaluating patients' perceived quality of life during treatment and follow-up. However, currently approved questionnaires do not exhaustively inform clinicians on how disease and treatments impact a patient's care journey.

In this context, narrative medicine has proven to be a valid and reliable methodology for integrating the patients' perspective into standard clinical evaluation. Qualitative methodologies provided by narrative medicine can enrich the information expressed in standardized questionnaires, allowing access to the existential and emotional components of the patients' care experience. Narrative medicine can capture the perception of quality of life, which is highly subjective and influenced by each individual's needs and expectations (i.e. relative deprivation).

Systematic collection of patient-reported outcomes (PROs) has proven to be a valid, reliable, and accurate methodology in oncology for assessing care pathway outcomes and monitoring drug toxicity, as impacts and symptoms may be overlooked or underestimated by the clinicians. Narrative medicine has also proven to be feasible and reliable in improving physician-patient communication and promoting a bio-psycho-social personalization of the care pathway, particularly when used with digital listening tools, such as the digital narrative diary. Studies on digital narrative medicine in oncology have shown the potential of digital platforms in promoting the listening of patients' needs by a multidisciplinary team throughout the care pathway, resulting in a positive impact not only on the patient but also on the healthcare team.

The transition from a traditional disease-centered to a more person-centered care model has led to the introduction of integrative medicine in oncological care centers. Through a rational and evidence-based use of lifestyles, psychological support and complementary therapies, integrative medicine promotes better control of side effects, greater adherence to treatment protocols, and optimization of the patients' quality of life throughout their care pathway. In the context of breast, integrative oncology combines conventional oncological treatments with integrative therapies to support individuals in their bio-psycho-social dimension, thus providing effective and minimally invasive responses to complex and sometimes unmet health needs.

The objective of this project is to employ these resources in a digital listening and communication pathway to benefit the quality of life of patients affected by HER2-negative advanced breast cancer.

Eligibility criteria: 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.

Primary outcomes:
measure: Standardized quality of life measurement
timeFrame: 12 months
measure: Perceived quality of life
timeFrame: 12 months
measure: Personalization of care pathway
timeFrame: 12 months
measure: Improvement of quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Validation of digital tools
timeFrame: 12 months
measure: Enhancement of communicative processes
timeFrame: 12 months
measure: Patients' awareness regarding their own disease condition
timeFrame: 12 months
measure: Strengthening of multidisciplinary team
timeFrame: 12 months
measure: Enhancement of information exchange and sharing of experiences among patients with the same condition
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico A. Gemelli - IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Alessandra Fabi
role: PRINCIPAL_INVESTIGATOR
References: