Clinical trial NCT06348654: New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer
Official title: Application of a New Digital Person-based Care (PbC) Model for the Treatment of Patients With HER2-negative Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Narrative Medicine
HER2-negative Breast Cancer
Patient Satisfaction
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population refers to women with HER2-negative advanced breast cancer (IHC score 0, 1+ or 2+ with unamplified FISH/SISH) in first- or second-line treatment, with advanced disease, undergoing cancer treatment.

Brief summary: 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.

Detailed description: In recent years, the health care system has undergone significant changes that have led to the emergence of a person-centered medicine paradigm. In this new scenario, outcomes of care pathways are evaluated not only on the basis of clinical outcomes but also in terms of the impact on patients' quality of life. Due to therapeutic advances, it therefore becomes increasingly necessary to adopt integrated, empathic and person-centered clinical approaches that also take into account patients' needs and expectations for care.

New measurement tools that assess also the patient's perspective have been introduced into clinical practice.

Among these new tools are Patient-Reported Outcome Measures (PROMs), aimed at determining patients' perceived quality of life during treatment and follow-up. Systematic collection of patient-reported outcomes has indeed been proven to be a valid, reliable, and accurate methodology in oncology, both for assessing treatment outcomes and monitoring drug toxicity, and for avoiding all those cases where impacts and symptoms are overlooked or underestimated by clinicians.

However, currently approved and standardized questionnaires do not comprehensively inform clinicians about how the disease and treatments affect the patient's care pathway.

In this context, narrative medicine, on the other hand, has proven to be a valid and reliable methodology capable of integrating the patient's perspective into standard clinical assessment.

Qualitative narrative medicine methodologies have been recognized as useful and effective to the extent that they allow clinicians to access the existential and emotional components of patients' experience of care, and for their ability to enrich the information expressed in standardized questionnaires. Narrative methodologies thus make it possible to capture perceptions of quality of life, and thus to capture a highly subjective dimension influenced by each individual's needs and expectations (e.g., relative deprivation).

Narrative medicine has also been shown to be feasible and reliable in improving doctor-patient communication and promoting bio-psycho-social personalization of the care pathway, particularly when used in combination 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 listening to patient needs, especially when listening is done by a multidisciplinary care team throughout the care pathway. It has also been seen how digital has a positive impact not only on the patient but also, more broadly, on the entire care team.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Standardized quality-of-life measurement
timeFrame: 12 months
measure: Perceived quality of life
timeFrame: 12 months
measure: Personalization of the care pathway
timeFrame: 12 months
measure: Quality of the patient-physician relationship.
timeFrame: 12 Months
Secondary outcomes:
measure: Interaction between multidisciplinary teams
timeFrame: 12 months
measure: Patient involvement and compliance in the care pathway
timeFrame: 12 Months
measure: lifestyles best suited to positively affect quality of life
timeFrame: 12 Months
measure: Awareness of disease condition
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma
name: Fabi Alessandra
role: PRINCIPAL_INVESTIGATOR
References: