Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348654
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-20
Brief Title:
New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Application of a New Digital Person-based Care PbC Model for the Treatment of Patients With HER2-negative Advanced Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InPERSON
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
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 patients 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 patients care pathway
In this context narrative medicine on the other hand has proven to be a valid and reliable methodology capable of integrating the patients 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 individuals needs and expectations eg 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
New measurement tools that assess also the patients 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 patients care pathway
In this context narrative medicine on the other hand has proven to be a valid and reliable methodology capable of integrating the patients 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 individuals needs and expectations eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None