Rein 3D PRINT PERSONALIZE
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: personalized 3D model pré-opérative education, generic 3D model pré-opérative education.
- Кому может быть актуально
- Состояния в реестре: Tumoral Kidney. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effects of a Personalized or Generic Three-dimensional Tumoral Kidney Model on Patient Experience and Professional-patient Interactions, Before and After Partial Nephrectomy
Обзор
The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers.
Подробное описание
The use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in comprehensive care that is way not enough promoted for now.
A pilot study from 2015 demonstrated the benefits of using personalized 3D-printed kidney models as educational mediation tools during the pre-operative consultation of patients scheduled for robot-assisted partial nephrectomy. The patient's understanding of his pathology and of the surgery was thus facilitated, leading to greater satisfaction during treatment.
For personalized medicine, it is important to consider the heterogeneity in culture and social backgrounds of patients in the doctor-patient relationship. Measuring health literacy help to identify and describe this heterogeneity in patient profiles. Patients with low literacy levels have higher levels of anxiety, particularly regarding surgery, and poorer post-operative recovery. Some studies highlight the importance of improving patient understanding with strategies to improve patients' health literacy and information provided by carers.
The goal of this study is therefore to investigate the benefits of using a personalized 3D-printed kidney model versus a generic 3D-printed kidney model as a mediation tool, all along the care pathway, on patients' experience and their interactions with carers, before and after partial nephrectomy.
To achieve this aim, 60 patients planned for robot-assisted laparoscopic partial nephrectomy will be randomized, in a 1:1 ratio, between the use of a personalized 3D kidney model and a generic 3D kidney model.
3D models will be presented to the patients according to the allocated study group during a preoperative education consultation. All patients will complete questionnaires about their health literacy level, their knowledge of kidney anatomy and tumor and their satisfaction about the using 3D-printed kidney models as educational mediation tools. Semi-structured interviews will be conducted at three different times: between the first consultation with the surgeon and the preoperative education consultation, between this second consultation and the surgery and after the post-operative consultation.
Вмешательства
- Другое personalized 3D model pré-opérative education
Before surgery, during a preoperative therapeutic education consultation, a personalized 3D models will be presented to the patients according to the allocated study group - Другое generic 3D model pré-opérative education
Before surgery, during a preoperative therapeutic education consultation, a generic 3D models will be presented to the patients according to the allocated study group
Первичные конечные точки
- Qualitative assessment of patient experience 1 [Срок оценки: between baseline and Day15 post-op]
- Qualitative assessment of patient experience 2 [Срок оценки: between baseline and Day15 post-op]
- Qualitative assessment of patient experience 3 [Срок оценки: between baseline and Day15 post-op]
Вторичные конечные точки (6)
- Description of interactions between carers and patients [Срок оценки: between baseline and Day15 post-op]
- Comparison of the evolution and frequency of terms used by patients in the 2 groups during their care. [Срок оценки: between baseline and Day15 post-op]
- Studying the use of the 3D-printed kidney model introduced during the medical information consultation up to the post-operative visit by describing the life of the model throughout the entire care process [Срок оценки: between baseline and Day 15 post-op]
- To study the level of understanding of renal anatomy and surgical issues according to the type of tool (personalized vs generic 3D printed model) [Срок оценки: baseline ; between D-1 and Day-15 from surgery ; Day 15 post-op]
- Comparison of the level of health literacy between the two groups at different times with changes in the average score on the literacy questionnaire (HLSEU-Q16: European Health Literacy Survey Questionnaire) [Срок оценки: baseline ; Day-30 post-op]
- Description of the changes perceived by carers in patients management in both group [Срок оценки: between baseline and year 1 post baseline]
Критерии участия
Критерии включения
Patients:
- Adult patients (≥ 18 years of age)
- Scheduled for surgical management by laparoscopic robotic-assisted partial nephrectomy (1st management for a unilateral or bilateral kidney tumor)
- Expressed consent for integration in the UroCCR database
- Expressed consent for participation in the Rein-3D Personalize study
- Patients affiliated or benefiting from social security system
Professionals:
- Professionals working with patients treated in the Urology, Andrology and Renal Transplant - Department of the Bordeaux University Hospital for at least two months prior to the implementation of 3D models
- Free, informed and signed consent
Критерии исключения
Patients
- Metastatic at inclusion
- Previous renal cancer(s)
- Single kidney at time of inclusion
- No preoperative CT scan, or poor-quality CT scan unable to provide reliable 3D modeling
- Person under legal protection (safeguard of justice, guardianship or curatorship)
- Difficulty understanding and expressing oneself in French
Professionals
- Professionals on internship lasting less than 6 months
- Professionals with no contact with patients
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Франция · 1 центр
- CHU de Bordeaux — Bordeaux
Публикации
- Pattou M, Masanet S, Jutand MA, Hoarau H, Sarrazin J, Pitout A, Richert L, Larribere H, Rubat Baleuri F, Jaffredo M, Ricard S, Faessel M, Sabatier J, Bernhard JC, Margue G. Effects of a personalized or generic three-dimensional tumoral kidney model on patient experience and caregiver-patient interactions, before and after partial nephrectomy, a randomized trial (Rein 3D Print Personalize-UroCCR 11 PMID 40824885
Идентификаторы
NCT: NCT06379698 · CHUBX 2023/78