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.

Conditions

• Tumoral Kidney

Intervention / Treatment

• Other: personalized 3D model pré-opérative education
• Other: generic 3D model pré-opérative education

Primary Outcome Measures

• Qualitative assessment of patient experience 1 (between baseline and Day15 post-op)
  Patient experience will be measured by a set of element including observations and 3 questionnaires described in outcome 1, outcome 2, outcome 3. Measurement of the progression in mean health literacy questionnaire score HLSEU-Q16 this questionnaire is a short version version of the European Health Literacy Survey Questionnaire (Sørensen et al., 2013), based on a model including 4 health information processing skills: accessing, understanding, evaluating and applying application of health information. The Items are scored from 'Strongly Disagree' to 'Strongly Agree', and from 'Cannot Do' to 'Very Easy'. The total score is produced by summing all items
• Qualitative assessment of patient experience 2 (between baseline and Day15 post-op)
  Patient experience will be measured by a set of element including observations and 3 questionnaires described in outcome 1, outcome 2, outcome 3. Measurement of the level of understanding of renal anatomy and surgical issues using the Bernhard et al. questionnaire. The knowledge questionnaire ( Bernhard 2016) consists of 4 parts: basic kidney physiology, basic kidney anatomy, tumor characteristics and planned surgical procedure. The patient answers 'False' , 'True' or 'Don't know'. The scores are calculated in each part by calculating the numbers of correct answers . These dimensions will be studied before and after the presentation of the model, and compared according to the model used.;
• Qualitative assessment of patient experience 3 (between baseline and Day15 post-op)
  Patient experience will be measured by a set of element including observations and 3 questionnaires described in outcome 1, outcome 2, outcome 3. Patient satisfaction is measured using the satisfaction questionnaire adapted from the Bernhard 2016 study. This measures how well the three-dimensional printed kidney model helped patients in learning " basic notions " about the kidney, and improving their understanding of : the disease, the scheduled surgery and the risk of complications related to the surgery. Each of the four dimensions is rated by a 10-point score ranging from 1 "no help at all" to 10 "great help". The average of the scores per dimension and an overall satisfaction score will be calculated and compared between the groups.

Countries

France

Locations and Investigators

• CHU de Bordeaux, Bordeaux, France (Recruiting)
  • Gaëlle MARGUE, Docteur

Study Officials

• Gaëlle MARGUE, Docteur (Principal Investigator) — University Hospital, Bordeaux