Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Introduction of a digital listening and communication pathway aimed at improving the quality of life of patients with advanced HER2-negative breast cancer

introduction of digital listening may improve the quality of life of patients withe breast cancer

Fabi Alessandra

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.

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.

New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer

Application of a New Digital Person-based Care (PbC) Model for the Treatment of Patients With HER2-negative Advanced Breast Cancer

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.

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 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.

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.

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.

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.

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.

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.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Principal Investigator

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Musculoskeletal Diseases

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Blood and Lymph Conditions

Rare Diseases

Diabetes Mellitus

Chronic Disease

Fibrosis

Rheumatic Diseases

Collagen Diseases

Cystic Fibrosis

Hematologic Diseases

Pancreatic Diseases

Gastrointestinal Diseases

Lung Diseases

Respiratory Tract Diseases

Genetic Diseases, Inborn

Infant, Newborn, Diseases

Disease Attributes

Connective Tissue Diseases

Chronic Graft Versus Host Disease

The Medical Honors Program students will fill out the Patient Provider Orientation Scale (PPOS). MHP students will then interview a patient with a chronic or life limiting illness.

The patients will fill out the PPOS scale. The patient will then have an Interview performed by MHP student

Investigators are interested in the impact that our activity has on the students' patient-centeredness. Investigators will use the Patient-Practitioner Orientation Scale (PPOS), which will be completed by both the student and the patient prior to the encounter. Following the interview, the co-investigators will lead a discussion with the patient and student. Investigators will discuss differences in patient and student PPOS scores, and how each party felt the interview went. Investigators will examine if the patients feel the interview differed from typical interactions with health care providers, and how this made the patient feel. The students will describe what was learned from the patients story as well as try to explore reasons why providers may not always learn the patient's illness story.

Patient Provider Orientation Scale

The MHP students took a course called Medical Humanities in the fall of 2016. MHP students learned patient interviewing skills and the importance of gathering the patients "illness story". The students will conduct an interview with a patient with chronic illness, which will be focused on gather information about how the patients illness affects daily life as well as interactions with the health care system.

Interview performed by MHP student

Robert Lawrence, MD

A qualitative study assessing the impact of early narrative medicine practice on Medical Honors Program (MHP) students' attitudes regarding patient-centered interactions, through interviewing patients with chronic or life-limiting illnesses to obtain their illness stories.

MHP students will develop a patient narrative for the patients interviewed. These narratives will be edited by the patient, and, with the permission of the patients, may be published as a collection of stories.

Teach MHP Students about obtaining the illness story and narrative medicine. This will be done during the curriculum of the Medical Humanities class in the fall of 2016.

Recruit patients on units and floors in Shands University of Florida (UF) Health that may potentially have patients that will be good candidates for enrollment in the patient narratives. These may include pediatric hematology and oncology patients, adult hematology and oncology patients, patients with diabetes, organ transplant patients, cystic fibrosis patients, and rheumatologic disorder patients. Investigators will communicate with child life/social workers, as well as faculty medical providers on these inpatient services to help identify appropriate patients for referral and recruitment. These faculty members will obtain authorization from the patient for the investigators to approach the patient regarding recruitment.

Once a patient has been identified, a co-investigator will introduce the project to the patient, review examples of the types of questions to be asked by the MHP student, provide opportunity for questions, obtain informed consent, and provide them with the patient-practitioner orientation scale (PPOS) for completion.

A MHP student will meet with the co-investigator, fill out the PPOS, and then interview the patient. The co-investigator will be present for the interview, but the investigator would like the MHP student to conduct the interview. The interview will be voice recorded with encryption for later transcription.

Following the interview, a co-investigator will lead a discussion to determine patient and student observations/opinions about such conversations. The co-investigator will address differences in PPOS responses from patient vs student, without specifically revealing the personal answers of each, and allow for discussion of how scales can be aligned to better the patient-physician relationship. This discussion will be voice recorded for transcription and qualitative analysis by the investigators

Following the interview, the MHP students will transcribe the patient narrative. During the interview, the student and patient will agree on whether the narrative is written from the first or third person point of view.

The initial informed consent will have a specific series of check boxes to address whether the patient approves of dissemination of their story. This initial consent will specifically state that this narrative will not be published prior to their approval of the final product. The patient will also have the opportunity to declare which patient identifiers, if any, will be changed for the publication. The narrative will be presented to the patient, who will then have the opportunity to make changes and edits. If extensive edits are necessary, a subsequent narrative will be presented to the patient for final approval prior to publication. The investigators will make every effort to get the patient approval in person, however because of the possibility of the patient being discharged before the narrative has been composed, investigators will identify an acceptable method of communication with the patient outside of the hospital (email, phone call) for this purpose. In the case of the patient being discharged and needing to obtain approval, verbal approval over the phone will be obtained by a co-investigator and a witness, and will keep this documentation in a binder locked in the PI's office.

Following the completion of the interviews, the MHP students will meet for a focus group to discuss as a group their observations from their patient encounters. This focus group will be audio recorded and transcribed by the co-investigators for qualitative analysis

After all patient narratives have been completed, narratives may be published in an online or book format, following the consent that the patient provided.

Impact of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes of Medical Students

Patients to People: Examining the Effects of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes in Medical Students. A Qualitative Study

The PPOS is an 18 item questionnaire developed to evaluate patient centered care. The items are rated on a 6 point Likert-type scale. It has two separate parts, sharing and caring, that can be either summed or divided for scoring purposes. Higher scores indicate more patient centeredness.

Total from the questions related to "sharing" on the PPOS. The sharing portion relates to how open the provider is in sharing power in the patient-physician relationship, or in the case of the patient filling out the form, how much the patient wishes to share the power in the patient-physician relationship.

Total from the questions related to "caring" on the PPOS. The caring portion relates to how oriented the provider is in caring for the patient as a person and not just a disease.

qualitative measurement of topics and themes discussed in immediate post-interview discussion between the co-investigator, MHP student, and patient

qualitative measurement of topics and themes discussed in the focus group held following all MHP students completing their individual interviews

University of Florida

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Medical Oncologists treating patients with metastatic colorectal cancer

Patients with metastatic colorectal cancer receiving re-staging CT scans

Christian S Adonizio, MD

The purpose of this study is to determine if the degree of agreement between patients and their physicians regarding the "story" of the illness correlates with improved patient symptom control and quality of life. Another goal of the study is to examine the actual language used by patients and physicians in a specific clinical situation.

The purpose of this study is to investigate the co-created therapeutic narrative in scheduled office visits between adult patients with metastatic colorectal carcinoma and their medical oncologists in a community practice setting. The study will focus on the negotiation of the illness narrative and the semiotic (primarily linguistic) tools employed. The study will involve patients from a large community cancer center from Northeastern Pennsylvania (this center sees about 3,000 new patients each year). About 85% of patients with cancer in the United States are treated in this type of setting (National Cancer Institute, 2007), and so many results from this population are applicable to most cancer patients in the United States. The location of this study makes it very different from the majority of medical anthropological studies that are usually performed in urban academic medical centers or in sites outside of the United States or Western Europe. Although community cancer centers are the location of most of the treatment of patients with cancer in the United States, there are few to no studies published studying this patient population.

Study of the Therapeutic Use of Language in Patients With Metastatic Colorectal Cancer

Critical Negotiations: Narrative Agreement, Negotiation, and Register Use in Encounters Between Patients With Metastatic Colorectal Carcinoma and Their Oncologists

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer	NCT06348654	Breast Cancer Narrative Medic... HER2-negative B... Patient Satisfa...	introduction of...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Impact of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes of Medical Students	NCT03041571	Narrative Medic... Chronic Disease Terminal Illnes... Cancer Diabetes Mellit... Cystic Fibrosis Rheumatologic D... Oncologic Disor... Hematologic Dis...	Patient Provide... Interview perfo...	8 Years - 100 Years	University of Florida
Study of the Therapeutic Use of Language in Patients With Metastatic Colorectal Cancer	NCT00711672	Colorectal Canc...		18 Years -	Hematology and Oncology Associates of NE Pennsylvania

Spots Global Cancer Trial Database for narrative medicine