New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer (InPERSON)

Application of a New Digital Person-based Care (PbC) Model for the Treatment of Patients With HER2-negative Advanced Breast Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Patient Satisfaction; Narrative Medicine; HER2-negative Breast Cancer
• Intervention / Treatment: Behavioral: introduction of digital listening may improve the quality of life of patients withe breast cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Fabi Alessandra; Phone Number: +39.0630157337; Email: alessandra.fabi@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized quality-of-life measurement	The integration of standardized quality-of-life measurement with the patient's subjective narrative through the application of validated narrative medicine methodologies. Primarily QoL questionnaires from EORTC QLQC-30 and QLQ-BR23, implemented with digital narrative tehniques.	12 months
Perceived quality of life	The improvement of the perceived quality of life of patients with advanced breast cancer,Primarily QoL questionnaires from EORTC QLQC-30 and QLQ-BR23, implemented with digital narrative tehniques.	12 months
Personalization of the care pathway	Personalization of the care pathway through integrative therapies, based on patients' needs, attitudes and lifestyles. This does not necessarily need standardized questionnaires, because if the patient raise concern about a sign or symptom, this will be properly evaluated with the last CTCAE available version.	12 months
Quality of the patient-physician relationship.	The improvement of the quality of the patient-physician relationship. This is not necessary linked to a standardized evaluation method or solely to an improvement in QoL measured with the already cited questionnaires. Dedicated perception scales will be created by the digital narrative team to explore if the proposed methods are feasible.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interaction between multidisciplinary teams	The strengthening of interaction between multidisciplinary teams. Personalization of the care pathway implicitly needs the involvement of other professional figures: psychologist, antropologist, radiotherapist, dietician, integrative care specialist. Based on this, the team will try to develop a "holistic" care pathway, tailored on the single patient.	12 months
Patient involvement and compliance in the care pathway	The validation of digital tools to introduce innovative models of patient involvement and compliance in the care pathway. The continuos feedback from the oncologist based on the narrative diary will help the clinician to estimate the treatment compliance and the possible side effects.	12 Months
lifestyles best suited to positively affect quality of life	The enhancement of communication processes aimed at informing metastatic patients about lifestyles best suited to positively affect quality of life. Through the collaboration with the integrative care team, if needed, a change in lifestyle with a structured schedule will be proposed to each single patient.	12 Months
Awareness of disease condition	Increasing patients' awareness of their disease condition, the effects of treatment, and the care needs that may arise during treatment. The diary gives to the patient the opportunity to develop an introspective dimension of the disease, and stimulates her to properly elaborate the steps of the care pathway.	12 Months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Fabi Alessandra, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 6392

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No