Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05893368 |
| Other study ID # |
ID5640 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
February 1, 2025 |
Study information
| Verified date |
May 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Alessandra Fabi, dr |
| Phone |
+390630157337 |
| Email |
alessandra.fabi[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
