Advanced Breast CancerPERGIQUALNCT05893368
New Model for Integrating Person-based Care (PbC) in the Treatment of Advanced HER2-negative Breast Cancer
An observational study of Advanced Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Sharing all key aspects associated with the quality of life in a single digital environment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 1 Feb 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: Women with HER2-negative advanced breast cancer (IHC score 0, 1+, or 2+ with non-amplified FISH/SISH) on 1st or 2nd line treatment, with advanced disease, under oncological treatment.
Who may be able to join
- Patient able to understand, sign and date the informed consent prior to any specific study procedure;
- Diagnosis of HER2-negative advanced breast cancer (ER and PgR hormone receptor negative or ER and/or PgR receptor positive), undergoing cancer treatment
- Age ≥18 years
- Knowledge of the Italian language
- Life expectancy ≥ 24 weeks
- Basic level of digital knowledge.
Who cannot join
- Inability to participate in the patient's study (psychiatric disorders, PS ECOG > 2) and unavailability of caregiver;
- Unavailability of an e-mail account or unavailability to use web-based tools (for the patient/caregiver);
- Patients who do not sign informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico A. Gemelli - IRCCS
Rome, 00168
Alessandra Fabi, +390630157337, alessandra.fabi@policlinicogemelli.it
Alessandra Fabi, +390630156124, alessandra.fabi@policlinicogemelli.it
About this study
Official title: New Model for Integrating Person-based Care (PbC) in the Treatment of Advanced HER2-negative Breast Cancer: InPerson Study
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".
Read more
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.
Read the detailed 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.
- Conditions
- Advanced Breast Cancer
- Being tested
- Sharing all key aspects associated with the quality of life in a single digital environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sharing all key aspects associated with the quality of life in a single digital environmentOther
A digital platform called DNMLAB (DNMLAB) offers the possibility of sharing all key aspects associated with the quality of life in a single digital environment by activating:
- a digital narrative diary in which the patient has the opportunity to share with the multidisciplinary team her needs, critical issues
- report Patient-Reported Outcome Measures (PROMs) aimed at detecting health-related quality of life (i.e. QLQ-C30-B23 EORTC).
- digital narrative diary focused on three main areas of health-related behavior-nutrition, physical activity, and sleep habits-aimed at personalizing and reshaping lifestyle, daily behaviors and, if required, the care pathway.
The patient will be guided by narrative prompts, but at the same time will always be free to share all aspects related to her lifestyle that she deems useful, in addition to those detected, to benefit from a personalized care approach.
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.
Measured: 12 months
Perceived quality of life
The improvement of perceived quality of life for patients with advanced breast cancer.
Measured: 12 months
Personalization of care pathway
The personalization of the care pathway with integrative therapies, based on the patients' needs, attitudes and lifestyles.
Measured: 12 months
Improvement of quality of life
The improvement of the quality of the patient-physician relationship.
Measured: 12 months
Secondary outcomes (5)
Validation of digital tools
The validation of digital tools to introduce innovative models of patient engagement and compliance in the care pathway.
Measured: 12 months
Enhancement of communicative processes
The enhancement of communicative processes aimed at informing metastatic patients about the most suitable lifestyles to positively impact their quality of life.
Measured: 12 months
Patients' awareness regarding their own disease condition
The increase of patients' awareness regarding their own disease condition, treatment effects, and care needs that may arise during treatment.
Measured: 12 months
Strengthening of multidisciplinary team
The strengthening of the multidisciplinary team interaction
Measured: 12 months
Enhancement of information exchange and sharing of experiences among patients with the same condition
The enhancement of information exchange and sharing of experiences among patients with the same condition in a privacy-protected digital environment.
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 posted7 Jun 2023
- Study start1 Mar 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandra Fabi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893368
- Sponsor's protocol ID
- ID5640
- Acronym
- PERGIQUAL
- Status last verified
- May 2023
- First submitted
- 29 May 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fabi A, Rossi A, Mocini E, Cardinali L, Bonavolonta V, Cenci C, Magno S, Barberi V, Moretti A, Besharat ZM, Iolascon G, Baldari C, Ferretti E, Botticelli A, Paris I, Scambia G, Migliaccio S. An Integrated Care Approach to Improve Well-Being in Breast Cancer Patients. Curr Oncol Rep. 2024 Apr;26(4):346-358. doi: 10.1007/s11912-024-01500-1. Epub 2024 Feb 24.
PubMed 38400984
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Model for Integrating Person-based Care (PbC) in the Treatment of Advanced HER2-negative Breast Cancer: InPerson Study
- ClinicalTrials.gov ID
- NCT05893368
- Acronym / sponsor ID
- PERGIQUAL / ID5640
- Conditions
- Advanced Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 7 Jun 2023 (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 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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with HER2-negative advanced breast cancer (IHC score 0, 1+, or 2+ with non-amplified FISH/SISH) on 1st or 2nd line treatment, with advanced disease, under oncological treatment.
Key inclusion criteria (6 listed)
- Patient able to understand, sign and date the informed consent prior to any specific study procedure;
- Diagnosis of HER2-negative advanced breast cancer (ER and PgR hormone receptor negative or ER and/or PgR receptor positive), undergoing cancer treatment
- Age ≥18 years
- Knowledge of the Italian language
- Life expectancy ≥ 24 weeks
Key exclusion criteria (3 listed)
- Inability to participate in the patient's study (psychiatric disorders, PS ECOG > 2) and unavailability of caregiver;
- Unavailability of an e-mail account or unavailability to use web-based tools (for the patient/caregiver);
- Patients who do not sign informed consent.
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 |
|---|---|---|
| Sharing all key aspects associated with the quality of life in a single digital environmentA digital platform called DNMLAB (DNMLAB) offers the possibility of sharing all key aspects associated with the quality of life in a single digital environment by activating: * a digital narrative diary in which the patient has the opportunity to share with the multidisciplinary team her needs, critical issues * report Patient-Reported Outcome Measures (PROMs) aimed at detecting health-related quality of life (i.e. QLQ-C30-B23 EORTC). * digital narrative diary focused on three main areas of health-related behavior-nutrition, physical activity, and sleep habits-aimed at personalizing and reshaping lifestyle, daily behaviors and, if required, the care pathway. The patient will be guided by narrative prompts, but at the same time will always be free to share all aspects related to her lifestyle that she deems useful, in addition to those detected, to benefit from a personalized care approach. | Other | – |
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.
Perceived quality of life
Time frame: 12 months
The improvement of perceived quality of life for patients with advanced breast cancer.
Personalization of care pathway
Time frame: 12 months
The personalization of the care pathway with integrative therapies, based on the patients' needs, attitudes and lifestyles.
Improvement of quality of life
Time frame: 12 months
The improvement of the quality of the patient-physician relationship.
5 secondary outcomes
Validation of digital tools
Time frame: 12 months
Enhancement of communicative processes
Time frame: 12 months
Patients' awareness regarding their own disease condition
Time frame: 12 months
Strengthening of multidisciplinary team
Time frame: 12 months
Enhancement of information exchange and sharing of experiences among patients with the same 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 24 Apr 2024.
- Derived from this study: PubMed 38400984Fabi A, Rossi A, Mocini E, Cardinali L, Bonavolonta V, Cenci C, Magno S, Barberi V, Moretti A, Besharat ZM, Iolascon G, Baldari C, Ferretti E, Botticelli A, Paris I, Scambia G, Migliaccio S. An Integrated Care Approach to Improve Well-Being in Breast Cancer Patients. Curr Oncol Rep. 2024 Apr;26(4):346-358. doi: 10.1007/s11912-024-01500-1. Epub 2024 Feb 24.
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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.
Alessandra Fabi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 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 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Alessandra Fabi, dr (+390630157337, 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?
On the ClinicalTrials.gov record for NCT05893368, which also lists 1 linked publication.
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 24 Apr 2024.