Tumoral KidneyR3DP-ANCT06035211
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety
A study testing 3D model pré-operative education in people with Tumoral Kidney, run by University Hospital, Bordeaux at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumoral Kidney
- What is being tested?
- 3D model pré-operative education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 6 sitesFrance
- Study dates
- 19 Sep 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU d'ANGERS
Angers
Pierre BIGOT, Pr.
- Recruiting
CHU de Bordeaux
Bordeaux
Jean-Christophe BERNHARD, Pr.
- Recruiting
CHU de CAEN
Caen
Thibaut WAECKEL, Dr.
- Recruiting
Hôpital Kremlin-Bicêtre
Le Kremlin-Bicêtre
Sébastien PARIER, Dr.
- Recruiting
CHU de La CONCEPTION
Marseille
Romain BOISSIER, Pr.
- Recruiting
CHU de NANTES
Nantes
Stéphane De VERGIE, Dr.
About this study
Official title: Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor. R3DP-A
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.
Read the 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.
- Conditions
- Tumoral Kidney
- Being tested
- 3D model pré-operative education
- Keywords
- Kidney Neoplasms, Renal-Cell Carcinoma, Nephron-Sparing Surgery, 3D Modeling, 3D Printing, Anxiety, STAI, Personalized Medicine
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D model pré-operative educationOther
Before surgery, during a preoperative therapeutic education consultation, 3D models will be presented to the patients according to the allocated study group
| Study group | Role | What they receive |
|---|---|---|
| Virtual 3D model group | Active comparator | exchange time with the virtual 3D model of the kidney to be operated on as information support Receives: Other: 3D model pré-operative education |
| 3D Printed Model Group | Active comparator | eexchange time with the printed three-dimensional model of the kidney to be operated on as information support Receives: Other: 3D model pré-operative education |
| Control group | No intervention | discussion time with the patient information sheet of the French Association of Urology (AFU) as information support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the mean pre-operative anxiety score per arm, by filling the STAI-state self-questionnaire
The STAI-Etat will be collected before surgery to evaluate the effect of using a personalized three-dimensional model of the patient's kidney during a pre-operative information visit .
Measured: Day-1 from surgery
Secondary outcomes (5)
Measurement of the progression of the mean anxiety score per arm, by filling STAI-Trait Anxiety self-questionnaire.
The progression of the mean anxiety score per arm, measured by STAI-State self-questionnaire at the three follow-up visits in the study and adjusted on the STAI-Trait score at baseline will assess feelings of apprehension, tension, nervousness and worries that the subject usually feels.
Measured: between baseline and Day 15 post-op
Measurement of the progression in mean health literacy questionnaire score HLSEU-Q16 between baseline and 15-day post-operative follow-up per arm
This questionnaire is a short version version of the European Health Literacy Survey Questionnaire based on a model including 4 health information processing skills: accessing, understanding, evaluating and applying application of health information .
Measured: between baseline and Day 15 post-op
Measurement of the mean pre-operative score for understanding disease and choice of treatment per arm by filling the WAKE questionnaire
The WAKE questionnaire is used assess the feeling of understanding of the disease and the choice of treatment preoperatively in each of the three groups, the questionnaire comprises five question on the understanding of the disease . Each dimension has 5 levels : very poor, poor,faire, good, very good or strongly desagree, disagree,neutral,agree or strongly agree
Measured: Day-1 from surgery
Measurement of the progression of quality of life in each of the three groups by filling the EQ-5D-5L questionnaire
The EQ-5D-5L questionnaire measures participants' quality of life.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Additinonally, the questionnaire records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: between inclusion and Day 15 post-op
Measurement of the average duration of the pre-operative information visit in each of the three groups
Measured: between Day-21 and Day-4 from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start19 Sep 2023
- Primary completion19 Sep 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumoral KidneyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe BERNHARD, Professeur, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035211
- Sponsor's protocol ID
- CHUBX 2022/18
- Acronym
- R3DP-A
- Status last verified
- Jun 2025
- First submitted
- 28 Aug 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor. R3DP-A
- ClinicalTrials.gov ID
- NCT06035211
- Acronym / sponsor ID
- R3DP-A / CHUBX 2022/18
- Conditions
- Tumoral Kidney
- Keywords
- Kidney Neoplasms, Renal-Cell Carcinoma, Nephron-Sparing Surgery, 3D Modeling, 3D Printing, Anxiety, STAI, Personalized Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 19 Sep 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual 3D model group | Active comparator | Other: 3D model pré-operative educationexchange time with the virtual 3D model of the kidney to be operated on as information support |
| 3D Printed Model Group | Active comparator | Other: 3D model pré-operative educationeexchange time with the printed three-dimensional model of the kidney to be operated on as information support |
| Control group | No intervention | –discussion time with the patient information sheet of the French Association of Urology (AFU) as information support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D model pré-operative educationBefore surgery, during a preoperative therapeutic education consultation, 3D models will be presented to the patients according to the allocated study group | Other | 3D Printed Model Group, Virtual 3D model group |
Primary outcome
Measurement of the mean pre-operative anxiety score per arm, by filling the STAI-state self-questionnaire
Time frame: Day-1 from surgery
The STAI-Etat will be collected before surgery to evaluate the effect of using a personalized three-dimensional model of the patient's kidney during a pre-operative information visit .
5 secondary outcomes
Measurement of the progression of the mean anxiety score per arm, by filling STAI-Trait Anxiety self-questionnaire.
Time frame: between baseline and Day 15 post-op
Measurement of the progression in mean health literacy questionnaire score HLSEU-Q16 between baseline and 15-day post-operative follow-up per arm
Time frame: between baseline and Day 15 post-op
Measurement of the mean pre-operative score for understanding disease and choice of treatment per arm by filling the WAKE questionnaire
Time frame: Day-1 from surgery
Measurement of the progression of quality of life in each of the three groups by filling the EQ-5D-5L questionnaire
Time frame: between inclusion and Day 15 post-op
Measurement of the average duration of the pre-operative information visit in each of the three groups
Time frame: between Day-21 and Day-4 from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Christophe BERNHARD, Professeur principal investigator
University Hospital, Bordeaux
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D model pré-operative education in people with Tumoral Kidney, run by University Hospital, Bordeaux at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe BERNHARD, Professeur (05 57 82 03 50, jean-christophe.bernhard@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the mean pre-operative anxiety score per arm, by filling the STAI-state self-questionnaire (time frame: Day-1 from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.