Breast CancerInPERSONNCT06348654
New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer
An observational study of Breast Cancer and Narrative Medicine, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Narrative Medicine, HER2-negative Breast Cancer
- What is being tested?
- introduction of digital listening may improve the quality of life of patients withe breast cancer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- introduction of digital listening may improve the quality of life of patients withe breast cancer
- Medical subject headings
- Breast Neoplasms, Narrative Medicine, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
introduction of digital listening may improve the quality of life of patients withe breast cancerBehavioural
Introduction of a digital listening and communication pathway aimed at improving the quality of life of patients with advanced HER2-negative breast cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start30 Mar 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FABI ALESSANDRA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Fabi Alessandra, Principal investigator, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348654
- Sponsor's protocol ID
- 6392
- Acronym
- InPERSON
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a New Digital Person-based Care (PbC) Model for the Treatment of Patients With HER2-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06348654
- Acronym / sponsor ID
- InPERSON / 6392
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| introduction of digital listening may improve the quality of life of patients withe breast cancerIntroduction of a digital listening and communication pathway aimed at improving the quality of life of patients with advanced HER2-negative breast cancer | Behavioural | – |
Primary outcome
Standardized quality-of-life measurement
Time frame: 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.
Perceived quality of life
Time frame: 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.
Personalization of the care pathway
Time frame: 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.
Quality of the patient-physician relationship.
Time frame: 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.
4 secondary outcomes
Interaction between multidisciplinary teams
Time frame: 12 months
Patient involvement and compliance in the care pathway
Time frame: 12 Months
lifestyles best suited to positively affect quality of life
Time frame: 12 Months
Awareness of disease condition
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabi Alessandra principal investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Narrative Medicine, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabi Alessandra (+39.0630157337, alessandra.fabi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized quality-of-life measurement (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.