Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy.

Study Overview
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Brief Summary
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The aim of the study is to verify whether a multimodal prehabilitation programme prior to robotic radical prostatectomy contributes to a faster recovery of quality of life after surgery, to better functional results (including erectile function and continence) and to less perioperative anxiety.

Detailed Description
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Single center randomized clinical trial including prostate cancer patients undergoing robotic-assisted radical prostatectomy at the Hospital Clínic de Barcelona. Patients will be randomized into two groups, one receiving multimodal prehabilitation and the other a control group. Multimodal prehabilitation consists of improving the functional and mental capacity of an individual to cope with a significant stressor, in this case surgery. The design of our prehabilitation program, lasting 4 weeks prior to surgery, consists of three parts; physical state, nutritional state and mental health. In the case of physical condition, a series of supervised and home-based exercises (aerobic and functional) will be carried out in addition to specific pelvic floor exercises. The nutritional status will be evaluated by a nutritionist. Diet guidelines will be given and if there are deficiencies they will be supplemented. Regarding mental health, a visit will be made with a psychologist and group and online therapies will be offered. The outcomes will be evaluated before starting the prehabilitation program, at the end of it (just before surgery) and at 4, 8 and 16 weeks after surgery. The outcomes include variables on physical, nutritional and mental state, health-related quality of life (HRQoL), and continence and erectile function.

Official Title
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Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy. A Randomized Clinical Trial.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Multimodal prehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with localized prostate cancer Candidates to robotic radical prostatectomy Exclusion Criteria: Non-localized prostate cancer Previous history of pelvic radiotherapy or pelvic surgery Failure to consent, Unwillingness to participate Anticipated failure to adhere to the program sessions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>This group of patients will not receive a pre-hab program | |
| Experimental: Multimodal prehabilitation<br>This patients will receive the pre-hab program | Behavioral: Multimodal prehabilitation<br>* Physical state: individualised physical status will be evaluated by a physiotherapist. A specific training program and pelvic floor exercises sessions will be led by a physiotherapist. Nutritional state: individual nutritional status will be evaluated by a nutritionist and intervention will be done if applicable. A nutrition group session will be held. Mental health: mindfulness group sessions led by psychologists will be held.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continence recovery | Change in continence during the prehabilitation program and postoperative recovery. International Consultation on Incontinence Questionnaire (ICIQ) Scoring scale: 0-21 Higher value means worse outcome | Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op) | 
| Perioperative anxiety levels | Change in perioperative anxiety levels Hospital Anxiety & Depression (HAD ) Scoring scale: 0-21 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) | Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical status by STS | Sit-to-Stand (STS) Time needed for 5 repeated chair rises. Higher time means worse physical status. | Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op) | 
| Change in physical status by 6MWT | 6 Minute Walk Test (6MWT) Distance covered over a time of 6 minutes. Higher time means worse physical status. | Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op) | 
| Change in perception of physical status | Yale physical activity survey (YPAS) Part 1 - Scoring scale: 0-85680 kcal/week Part 2 - Scoring scale: 0-142 Part 3 - Scoring scale: 0.7-1.3 Higher values indicates higher activity. | Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op) | 
| Erectile function recovery | International Index Erectile Function (IIEF-5) Change in erectile function during the prehabilitation program and postoperative recovery. Scoring scale: 5-25 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction | Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op) | 
| Change in perceived general quality of life | EORTC QLQ - C30 Scoring scale: 0-100 Higher value indicates higher perceived general quality of life | Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op) | 
| Change in perceived prostate quality of life | EORTC QLQ - PR25 Scoring scale: 0-100 Higher value indicates higher perceived prostate quality of life | Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op) | 
| Early postoperative morbidity by CDC | Clavien-Dindo Classification (CDC) Scoring scale: 1-5 Higher value indicates more severe complication | Week 8 (post-op) | 
| Early postoperative morbidity by CCI | Comprehensive Complications Index (CII) Scoring scale: 0-100 Higher value indicates more severe complication | Week 8 (post-op) | 
| Perceived application usability | Usability questionare Includes a combination of the System Usability Scale (SUS) and the Net Promoter Score (NPS). Scoring scale: 0-100 Higher value indicates better perceived usability | Week 4 | 
| Satisfaction with the multimodal program | Satisfaction questionnaire Scoring scale: 0-45 Higher value indicates higher satisfaction | Week 4 | 
| Nutritional status | Nutritionist final evaluation summarized as optimal or suboptimal by the specialist. | Week 0 and 4 |