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

NCT06348654 | Not Yet Recruiting

• 1 other identifier: 6392
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Narrative Medicine; HER2-negative Breast Cancer; Patient Satisfaction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Interaction between multidisciplinary teams

  12 months

• Patient involvement and compliance in the care pathway

  12 Months

• lifestyles best suited to positively affect quality of life

  12 Months

• Awareness of disease condition

  12 Months

Interventions

introduction of digital listening may improve the quality of life of patients withe breast cancer BEHAVIORAL

Introduction of a digital listening and communication pathway aimed at improving the quality of life of patients with advanced HER2-negative breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Breast Neoplasms; Narrative Medicine; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Narration; Communication; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Fabi Alessandra

  Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabi Alessandra

CONTACT

+39.0630157337; alessandra.fabi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 5, 2024
• Study Start: March 30, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-03