Clinical trial NCT06379698: Rein 3D PRINT PERSONALIZE
Official title: Effects of a Personalized or Generic Three-dimensional Tumoral Kidney Model on Patient Experience and Professional-patient Interactions, Before and After Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumoral Kidney
Keywords: Renal-Cell Carcinoma
Nephron-Sparing Surgery
3D Model
3D Printing
Personalized Medicine
Literacy Questionnaire
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Qualitative assessment of patient experience 1
timeFrame: between baseline and Day15 post-op
measure: Qualitative assessment of patient experience 2
timeFrame: between baseline and Day15 post-op
measure: Qualitative assessment of patient experience 3
timeFrame: between baseline and Day15 post-op
Secondary outcomes:
measure: Description of interactions between carers and patients
timeFrame: between baseline and Day15 post-op
measure: Comparison of the evolution and frequency of terms used by patients in the 2 groups during their care.
timeFrame: between baseline and Day15 post-op
measure: 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
timeFrame: between baseline and Day 15 post-op
measure: To study the level of understanding of renal anatomy and surgical issues according to the type of tool (personalized vs generic 3D printed model)
timeFrame: baseline ; between D-1 and Day-15 from surgery ; Day 15 post-op
measure: 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)
timeFrame: baseline ; Day-30 post-op
measure: Description of the changes perceived by carers in patients management in both group
timeFrame: between baseline and year 1 post baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Gaëlle MARGUE, Docteur
role: PRINCIPAL_INVESTIGATOR
References: