Application of a New Digital Person-based Care (PbC) Model for the Treatment of Patients With HER2-negative Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Standardized quality-of-life measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Standardized quality-of-life measurement
时间窗: 12 months
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.
Personalization of the care pathway
时间窗: 12 months
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.
Perceived quality of life
时间窗: 12 months
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.
Quality of the patient-physician relationship.
时间窗: 12 Months
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.
次要结局
- Interaction between multidisciplinary teams(12 months)
- lifestyles best suited to positively affect quality of life(12 Months)
- Patient involvement and compliance in the care pathway(12 Months)
- Awareness of disease condition(12 Months)
研究者
FABI ALESSANDRA
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS