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

Symptoms and General Pathology

Nervous System Diseases

Behaviors and Mental Disorders

Cancer Pain

Pain

Neurologic Manifestations

Quality of Life

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Analgesics

Psychotropic Drugs

Channel Blockers

Anticonvulsants

Anesthetics

Ropivacaine

Morphine

Duloxetine Hydrochloride

Pregabalin

Analgesics, Opioid

Narcotics

The control group will be composed of 15 patients who will receive oral drug treatment according to the Clinical Protocol and Therapeutic Guidelines for Chronic Pain of the Brazilian Ministry of Health. The drugs included in the treatment plan are morphine (60 mg/day), pregabalin (150 mg/day) and duloxetine (60 mg/day), available free of charge to the participating patients. The treatment will be carried out orally in a home environment.

The intervention group will be composed of 15 patients who will undergo a surgical procedure for subcutaneous implantation of a catheter (Celsite ST304-19BBraun) that allows epidural administration of morphine and ropivacaine drugs. The treatment plan for such patients includes Patient Controlled Analgesia (PCA). Patients in this group will receive, via catheter, an anesthetic solution containing 2.0 mL of morphine (1.0 mg/mL), 3.0 mL of ropivacaine (7.5 mg/mL) and 5.0 mL of distilled water. For 24 hours after this application, if the patient continues to have pain, they may use a rescue dose of oral morphine of 10 mg.

Implantation of an epidural catheter for administration of morphine and ropvacaine

Interventional Group (Epidural morphine)

Oral administration of morphine, pregabalin or duloxetin

Control Group (Oral morphine)

Larissa Helena LT Pacheco, PhD

Carlos Marcelo Barros, M.D.

Márcia Helena MC Podestá, PhD

Liliana B Vieira, PhD

Carla S Ceron, PhD

Vanessa B Boralli, PhD

Carolina Aparecida F Almeida, MSC

Rafaela F Rodrigues, PhD

Larissa LT Pacheco, PhD

In 2012, more than 14 million cases of cancer were diagnosed worldwide, with the forecast for 2025 exceeding 20 million. Pain is the most critical symptom that accompanies cancer. The development of disease generates the need for oncological palliative care and adequacy of the structure by Public Health Care System. In this context, this study aims to evaluate an alternative to the treatment plans provided for in the Brazilian's Public Health Care System table. The objective is to carry out a cost-effectiveness analysis of the epidural administration of morphine and ropivacaine in patients with abdominal neoplasia, and pain that is difficult to clinically control, which leads to an improvement in the quality of life, functional conditions and survival of patients, and that reduces the cost to the Brazilian's Public Health Care System. This is a randomized clinical trial. Patients will be divided into two groups: control and intervention. The control group will receive oral treatment according to the Clinical Protocol and Therapeutic Guidelines for Chronic Pain of the Brazilian's Ministry of Health: morphine, pregabalin and duloxetine. The intervention group will receive an anesthetic solution containing morphine and ropivacaine for epidural administration through a surgically implanted catheter. Pain, quality of life, functional capacity and survival will be evaluated using the following instruments: Visual Analogue Scale; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire "Core" 30; Karnofsky Performance Scale; Eastern Cooperative Oncology Group Scale; Palliative Performance Scale; and Palliative Prognosis Index. It is expected that, at the end of the study, the intervention group will represent a significant savings for the Public Health Care System, due to the decrease in the number of hospitalizations/day and the possible complications due to the lack of effectiveness of the oral treatment. It is expected that the results found will produce scientific support to disseminate the proposed treatment plan for Brazilian's Public Health Care System patients in palliative care.

Control group: oral route morphine Intervention group: epidural route morphine

Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment

Effectiveness of Epidural Morphine and Ropivacaine Treatment for Abdominal Cancer Pain in Patients of Brazilian's Public Health System

Change From Baseline in Pain Scores on the Visual Analog Scale (0 means no pain and 10 means worst pain) in patients in the control group and intervention group for up to 60 days.

Change of quality of life score by the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30), which consists of a likert-type scale ranging from 1 to 4 for functions and symptoms, where 1= not at all, 2=slightly, 3= moderately, and 4 = very much. If the resulting score on the functional scale is high, this represents a healthy functional level, while a high score on the symptom scale represents a low level of symptom tolerance and treatment side effects. This scale also assesses overall health, ranging from 1 to 7, with 1=bad and 7 = very good

Change in the patient's functional status by the Karnofsky Performance Scale (KPS), which ranges from 100% to 0%, where 100% means no evidence of disease and 0% means death

Change in disease status using the Eastern Cooperative Oncology Group (ECOG) scale, ranging from 0 to 5, where 0 = completely active and 5 =dead

Change in clinical-functional status by the Palliative Performance Scale (PPS), which ranges from 100 to 0%, where 100% = good clinical-functional status and 0%= dead

Change in survival time by the Palliative Prognosis Scale (PPI), which assesses PPS, presence of delirium, dyspnea, oral intake and edema, where each factor presents a score and at the end the scores are summed and the patient is classified into group A (Total Score \< 2.0): \> 6 weeks survival, group B (Total Score between 2.0 - 4.0): 3 - 6 weeks survival and group C (Total Score \> 4.0): \< 3 weeks survival

For cost-effectiveness analysis, a direct cost analysis using the cost-effectiveness ratio will be used. The costs considered in this study will be the direct non-medical and direct medical costs. For direct cost analysis, the microcosting technique will be used.

For economic analysis, the incremental cost-effectiveness ratio (ICER) will be used. Once a CERI is obtained, the result is evaluated by defining a cost-effectiveness threshold, which aims to identify values that society considers feasible, from an economic point of view, to be incorporated as additional costs in society's spending on health (BRASIL, 2014).

Once the RCEI is obtained, the next step in a pharmacoeconomic analysis will be to perform a sensitivity analysis of the parameters involved during the research.

Patients will undergo blood draws to obtain plasma, 1:30h after taking morphine (oral or epidural) which will later be quantified for morphine by gas chromatography.

The amount of morphine found in plasma (outcome 8) will be correlated with the therapeutic effects (pain levels by Visual Analog Scale)

BDNF quantification will be done in the plasma of the patients, using the BDNF enzyme-linked immunosorbent assay (ELISA) kit from sigma and adverse effects

Fundação de Amparo à Pesquisa do estado de Minas Gerais

Universidade Federal de Alfenas

PhD Professor

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:

\>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list \<100 ng/dL - no colonoscopy

Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.

Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:

Positive - colonoscopy as per waiting list Negative - no colonoscopy

Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.

This test measures the amount of blood within the submitted stool specimen

Qualitative fecal immunochemical test

This test detects presence or absence of blood within a submitted stool specimen.

Quantitative fecal immunochemical test

Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.

Colonoscopy

Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.

Cost analysis

Hospital Anxiety and Depression Scale (HADS) questionnaire

Anxiety scores

A 5-point patient satisfaction score will be documented at each patient visit related to screening.

Patient satisfaction scores

April C Roslani, MBBCh

The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral).

It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.

Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral

Evaluating the Effectiveness of Screening Strategies Using Quantitative Versus Qualitative Fecal Immunochemical Test (FIT) to Prioritize Urgency of Colonoscopy Referral - a Randomized Controlled Trial Protocol

Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm

Total costs incurred as a result of the screening process

As measured by the Hospital Anxiety and Depression Scale (HADS)

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
Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment	NCT05558397	Cancer Pain Opioid Use Cost Analysis Palliative Care Epidural Route Morphine-ropiva... Quality of Life Rational Use of...	Interventional ... Control Group (...	18 Years - 75 Years	Universidade Federal de Alfenas
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral	NCT02037646	Colorectal Canc...	Qualitative fec... Quantitative fe... Colonoscopy Cost analysis Anxiety scores Patient satisfa...	50 Years -	University of Malaya

Spots Global Cancer Trial Database for cost analysis