Clinical trial NCT06035211: Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety
Official title: Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor. R3DP-A
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumoral Kidney
Keywords: Kidney Neoplasms
Renal-Cell Carcinoma
Nephron-Sparing Surgery
3D Modeling
3D Printing
Anxiety
STAI
Personalized Medicine
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate the impact of showing and handling a three-dimensional modelization of a patient's tumoral kidney the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI state score. 3 types of pre-operative information were compared (3D virtual model, 3D printed model, and information) using a randomization.

Detailed description: Announcement of serious illnesses and especially cancerous disease has major impacts on one's psychological field. Need of surgery can create even other fears due to its unknown nature. 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. In the field of surgery, available methods to deal with pre-operative anxiety are massively represented by anxiolytics drugs, only few other devices were evaluated.

Technological development in healthcare has seen the rising of three-dimensional media, especially in surgery, for procedure planning. There is no doubt that this tool is effective in helping surgeons regarding the studies published within the past few years but there is no such evidence concerning the benefit for patients. Some authors report improvement of patients understanding and great satisfaction referring to the usefulness of this tool. But none of these papers evaluated anxiety.

The goal of this research is to measure the effect of a personalized three-dimensional model of patients' tumoral kidney on peri-operative anxiety.

For this purpose this clinical trial is designed as following: a total of 234 (78\*3) patients planned to have a nephron-sparing surgery for kidney tumor are going to be randomly assign in 3 different groups. Inside the 2 interventional groups, patients' kidneys will be modelled in three dimensions, but in one of the two groups, the model will be 3D-printed. The control group will include patients for whom the pre-operative information will be made based on standardized information letter from the French Urological Association.

Before surgery, during a preoperative therapeutic education consultation, 3D models will be presented to the patients according to the allocated study group. All patients will have to complete questionnaires to assess their anxiety level, their quality of life, their health literacy level and their understanding of disease and surgical procedure.

One month after surgery, during the post-operative consultation, patients will also fill out the different questionnaires to assess their anxiety level, quality of life, and level of litteracy.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years of age)
* Scheduled surgical management by laparoscopic partial nephrectomy with robotic assistance for kidney tumor
* Unilateral kidney tumor or 1st surgery for bilateral involvement
* Consent expressed for integration of the UroCCR cohort,
* Expressed consent for participation in the 3D Anxiety study.
* Patients affiliated or benefiting from a social security plan

Exclusion Criteria:

* Refusal of consent or participation
* Difficulty understanding and expressing oneself in French
* Patient under guardianship or curatorship
* No preoperative CT scan available for 3D modeling

Primary outcomes:
measure: Measurement of the mean pre-operative anxiety score per arm, by filling the STAI-state self-questionnaire
timeFrame: Day-1 from surgery
Secondary outcomes:
measure: Measurement of the progression of the mean anxiety score per arm, by filling STAI-Trait Anxiety self-questionnaire.
timeFrame: between baseline and Day 15 post-op
measure: Measurement of the progression in mean health literacy questionnaire score HLSEU-Q16 between baseline and 15-day post-operative follow-up per arm
timeFrame: between baseline and Day 15 post-op
measure: Measurement of the mean pre-operative score for understanding disease and choice of treatment per arm by filling the WAKE questionnaire
timeFrame: Day-1 from surgery
measure: Measurement of the progression of quality of life in each of the three groups by filling the EQ-5D-5L questionnaire
timeFrame: between inclusion and Day 15 post-op
measure: Measurement of the average duration of the pre-operative information visit in each of the three groups
timeFrame: between Day-21 and Day-4 from surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'ANGERS
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: CHU de CAEN
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Kremlin-Bicêtre
city: Marseille
country: France
facility: CHU de La CONCEPTION
city: Nantes
country: France
facility: CHU de NANTES
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-Christophe BERNHARD, Professeur
role: PRINCIPAL_INVESTIGATOR
References: