Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

The control group is based on the pre-existing organization, with no digital patient follow-up tools.

The UroConnect device has a "patient" interface for presenting self-questionnaires and access to a library of educational content and a "caregiver" interface to rationalize and optimize the nurse's activity of perioperative coordination in his task

Inplementation of UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination.

Uroconnect Follow Up Group

Jean-Christophe Bernhard, MD, PhD

Pierre Bigot, Pr

Jean-Christophe Bernhard, MD,PhD

Pierre Gimel, Dr

Thibaut Waeckel, Dr

Alexandre Ingels, Dr

Romain Boissier, Pr

Jean-Jacques Patard, Pr

Alexis Fontenil, Dr

Karim BENSALAH, Pr

Hervé LANG, Pr.

Nicolas Doumerc, Dr

The project proposes to evaluate the interest of the UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination

Kidney cancer represents 2 to 3% of solid cancers in adults. Worldwide, an estimated 431,288 people a year are diagnosed with kidney cancer. Each year, in France, 13,500 patients undergo total or partial nephrectomy. The development of minimally invasive surgical techniques and the structuring of innovative care pathways for the management of renal tumors in Enhanced Rehabilitation After Surgery (RAAC) and even on an outpatient basis have led to a significant reduction in the length of stays. The physiognomy of the course of care for patients operated on for a renal tumor is completely modified and generates for the patient a feeling of deterioration in the quality of care and disruption of medical follow-up.

The objective is to deploy a model for coordinating the perioperative care pathway of patients who have undergone nephrectomy for renal tumor in several French centers in order to assess the impact for patients, caregivers and the health system.

This coordination would lead to the formalization of a nurse coordinator job profile adapted to the specificities of oncological surgery and the tools necessary for its implementation. The UroConnect device has a "patient" interface for presenting self-questionnaires and access to a library of educational content and a "caregiver" interface to rationalize and optimize the nurse's activity of perioperative coordination in his task.

cross-sectional stepped wedge cluster randomized controlled trial

Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination (UroCCR 126)

Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination

In the 30 post-operative days, number of unscheduled and uncoordinated care utilizations (emergency visits, re-hospitalizations in urology, general medicine or urology consultations) corresponding to the difference between the use of care identified in the National health data system (SNDS) and scheduled and coordinated care, identified in the patient file of the initial hospitalization for scheduled care and by the coordinating nurse for coordinated care.

Patient anxiety measured by the State-Trait Anxiety Inventory STAI, The STAI questionnaire assesses anxiety as a personality trait and an emotional state and comprised 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

Patient satisfaction and experience measured by the e-Satis questionnaire .The e-satis questionnaire was created and validated in French by the Haute Autorité de Santé (HAS). It is used as a continuous measure of inpatient satisfaction and experience. It is therefore routinely collected by the HAS.

the e-Satis questionnaires are divided into "dimensions" of the patient pathway (from admission to discharge). Patients respond on a scale ranging from "poor" to "excellent" or from "never" to "always". For each dimension, an overall patient experience and satisfaction score is calculated (A score calculation guide is available on the HAS website).

Nature and reasons for seeking care declared by the patient and confirmed by the doctor who treated him/her

Number of re-hospitalizations for complications at D30, use of medical care (medical consultations and hospitalizations) in the 30 days following surgery (SNDS).

Number of alerts generated by UroConnect.

Evaluation of nurse activity due to patient requests on UroConnect

In each center, professionals and patients will be asked to take part in an individual interviews. This interview will focus on understanding the determining factors in the appropriation of the system and its impact from the point of view of professionals and patients, by identifying 1/ the factors that hinder and encourage appropriation of the system, 2/ the nature of the changes brought about in professional practice and in the patient's care pathway, the patient's feelings in terms of effects on his or her quality of life, disease management and relationship with carers, 3/ the individual, contextual, sociocultural and technical factors in the effectiveness of the intervention.Interview guides will be drawn up in advance, in line with the objectives and hypotheses of the research, and based on the findings of existing literature, such as theoretical models of behavioral and organizational change.

Difference in actual costs (€), from the hospital's point of view, between phases with and without the digital tool .

Difference in inpatient and outpatient costs (€) between the 2 strategies

University Hospital, Bordeaux

Blood and Lymph Conditions

Behaviors and Mental Disorders

Hematologic Neoplasms

Quality of Life

Patients eligible for CAR-T treatment for their hemopathy at TOULOUSE University Hospital under early access or marketing authorization or as part of a clinical trial between 01/01/2019 and 31/12/2028

Patients eligible for CAR-T treatment

Pierre BORIES, MD

Sandra DE BARROS

Adoptive immunotherapy using CAR-T cells is now one of the Advanced Therapy Medicines routinely used for relapsed or refractory lymphoid hemopathies. In 2023, in France, 5 types of CAR-T cells have marketing authorization for 6 different indications. However, these marketing authorizations are based on clinical trials involving a limited number of selected patients. Real-life data are essential for assessing the post-authorization use of these innovative treatments. The French national DESCAR-T registry, promoted by LYSARC and in which Toulouse University Hospital plays an active role, is an international reference for this real-life evaluation. It does not, however, allow precise evaluation of patient-centered indicators and care pathways.

With the increasing number of indications and candidate patients, Toulouse University Hospital, the only healthcare facility authorized in the Western Occitanie region to administer CAR-T cells, is faced with growing hospital needs and longer treatment times. In 2023, this has necessitated the implementation of new ambulatory and inter-facility care pathways in collaboration with the referral centers of the Onco-Occitanie Ouest regional cancer network. The selection of patients for CAR-T cell treatment is based on objective clinical criteria linked to the pathology (histology, morphological localization, size and kinetics of the tumor mass) and the patient (physiological age, performance index, comorbidities, patient choice). Because of their innovative nature, in a difficult psychological and physical context for the patient (refractory disease), CAR-T cell care pathways also need to be evaluated in terms of their "quality of life" dimension. The impact of non-biological determinants (also described as social and territorial inequalities in health) such as place of residence and distance from healthcare provision, marital, economic and social status, has never been explored on the accessibility and progress of the CAR-T cell treatment pathway.

The creation of a registry of patients eligible for CAR-T cells at Toulouse University Hospital will enable these lines of research to be explored on the scale of a region with a population of 3 million.

Ambispective observational cohort: This observational study is monocentric. For each patient, data will be collected during 5 years.

Real-life Management of Patients Eligible for CAR-T Cell Therapy

Evaluation of the Real-life Management of Patients Eligible for CAR-T Cell Therapy for Hematologic Malignancies at Toulouse University Hospital

Overall survival from CAR-T cell injection to all-cause death

progression-free survival from CAR-T cell injection to date of progression and overall survival from CAR-T cell injection to all-cause death progression-free survival from CAR-T cell injection to date of progression and overall survival from CAR-T cell injection to all-cause death

number of days between the multidisciplinary consultation meeting and the injection of CAR-T cells

Ligue contre le cancer, France

Janssen, LP

University Hospital, Toulouse

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Precarious patients - exposed - will be those identified as precarious by at least one of the three scores (EPICES, Pascal, European Deprivation Index)

Non precarious patient - non exposed - will be all the patients identified as non-precarious by the three scores (EPICES, Pascal, European Deprivation Index)

Exposed

Non exposed

Charlotte NGO, MD

Precariousness is a multifactorial concept that can be broken down in the form of economic insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an impact on health that is difficult to assess precisely because it also impacts on other factors that may themselves influence health. Therefore, the understanding of the impact of precariousness on health involves studying individuals in their context.

Our study is designed to assess the impact of precariousness on the history of breast cancer, on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis. Indeed, the socio -economic and geographical inequalities affect the history of breast cancer, treatment and its delay and post- treatment rehabilitation.

The main objective of this project is to compare the stage of disease at diagnosis (according to the TNM classification) in deprived and non deprived patients. The secondary objectives are to compare in the two groups - the socio-economic and geographical inequalities - the direct and indirect costs related to the management, the out-of pocket costs and to describe, based on individual inequalities identified, the pathway of care of the patient.

These objectives will be pursued in the framework of an observational cohort study, prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each precarious patient will be matched to a non- precarious patient in the same age group, regardless of the center. The study will include any patient resident in Ile de France seeking treatment for breast cancer, regardless of the stage.

All patients seeking treatment for breast cancer, regardless of the stage, can be included in the study. Three scores of precariousness will be applied to all patients (EPICES score, Pascal score and the European Deprivation Index). Patients identified as precarious by at least one of those three scales will be in the exposed group. The others will be in the non-exposed group.

Baseline assessment T0:

Are required only the clinical examination and radiological evaluation with the tumor size and node involvement according to TNM classification. A questionnaire will be distributed including EPICES score, Pascal score and European Deprivation Index. The baseline questionnaire will also assess the socio-economic characteristics of patients and the care trajectory before arriving in the center (see appendix).

Follow-up visits:

The following questionnaire will be distributed during a consultation that is scheduled in the routine care. There will be no additional consultation imposed on the patient.

* T1: questionnaire at 3 months after inclusion
* T2: questionnaire at 6 months after inclusion
* T3: questionnaire at 12 months after inclusion

Questionnaires will be focused on direct-costs and out-of-pocket costs, socio-economical characteristics, rehabilitation, return to work.

Economic and Social Disparities and Breast Cancer

Breast Cancer and Precariousness: Influence of Socio-demographic Inequalities in Cancer Stage at Diagnosis, Treatment Management and Rehabilitation in the Ile de France Area

TNM classification according to initial clinical and radiological assessment

National Cancer Institute, France

Paris West University Nanterre La Défense

Paris 12 Val de Marne University

Fondation Ophtalmologique Adolphe de Rothschild

Assistance Publique - Hôpitaux de Paris

Behavior, Addictive

Compulsive Behavior

Impulsive Behavior

Paramedical professionals of the Lucien Neuwirth Cancer Institute

Semi directive interview will be performed to try to define the management of addictions in the oncology care course. Thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.

Semi directive interview

Elise Verot

Nowadays, guidance is given on the implementation of innovative approaches to promote autonomy and user participation through strategies designed to strengthen the patient's empowerment. \[SNS 2018-2022, Ministère des Solidarités et de la Santé\] The 2014-2019 Cancer Plan calls for the systematic support of smokers during smoking cessation. This means that health workers need to be trained to help with smoking cessation, as well as the motivational attitude that reinforces the patient's smoker's self-esteem as well as his desire to off-load this addiction. \[Perriot, Underner, Peiffer, Dautzenberg, 2018\] It is recommended that these interventions be included from the beginning of the management, once the diagnosis of Cancer is made. It seems legitimate then to wonder about the place of choice the Motivational Interview (EM) could have in the course of cancer care, for the management of addictions during the treatment of cancer. We therefore wish to carry out descriptive qualitative research in the Lucien Neuwirth Oncology Institute in order to try to define the management of addictions in the oncology care course. Thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.

The Treatment of Addictions in the Course of Care in Oncology: an Inventory of Fixtures Among Paramedical Professionals

We therefore wish to carry out descriptive qualitative research in the Lucien Neuwirth Oncology Institute in order to try to define the management of addictions in the oncology care course. In a first time, number of addiction managements will be reported.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination (UroCCR 126)	NCT06047600	Digitizing Peri...	Uroconnect Foll...	18 Years -	University Hospital, Bordeaux
Real-life Management of Patients Eligible for CAR-T Cell Therapy	NCT06369389	Hemopathy	Patients eligib...	18 Years -	University Hospital, Toulouse
Real-life Management of Patients Eligible for CAR-T Cell Therapy	NCT06369389	Hemopathy	Patients eligib...	18 Years -	University Hospital, Toulouse
Economic and Social Disparities and Breast Cancer	NCT02948478	Breast Cancer	Exposed Non exposed	18 Years -	Assistance Publique - Hôpitaux de Paris
The Treatment of Addictions in the Course of Care in Oncology: an Inventory of Fixtures Among Paramedical Professionals	NCT03706937	Paramedical Pro...	Semi directive ...	18 Years -	Institut de Cancérologie de la Loire

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