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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Behavioral: Multimodal prehabilitation

• Registration Number: NCT05553327
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-05-31
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15
• Primary Completion: 2023-12-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal prehabilitation	Multimodal prehabilitation	This patients will receive the pre-hab program

Primary Outcome Measures

Name	Time	Method
Perioperative anxiety levels	Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)	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)
Continence recovery	Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)	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

Secondary Outcome Measures

Name	Time	Method
Change in physical status by STS	Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)	Sit-to-Stand (STS); Time needed for 5 repeated chair rises. Higher time means worse physical status.
Perceived application usability	Week 4	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
Change in physical status by 6MWT	Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)	6 Minute Walk Test (6MWT); Distance covered over a time of 6 minutes. Higher time means worse physical status.
Erectile function recovery	Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)	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
Change in perceived general quality of life	Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)	EORTC QLQ - C30; Scoring scale: 0-100 Higher value indicates higher perceived general quality of life
Early postoperative morbidity by CCI	Week 8 (post-op)	Comprehensive Complications Index (CII); Scoring scale: 0-100 Higher value indicates more severe complication
Change in perception of physical status	Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)	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.
Change in perceived prostate quality of life	Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)	EORTC QLQ - PR25; Scoring scale: 0-100 Higher value indicates higher perceived prostate quality of life
Early postoperative morbidity by CDC	Week 8 (post-op)	Clavien-Dindo Classification (CDC); Scoring scale: 1-5 Higher value indicates more severe complication
Nutritional status	Week 0 and 4	Nutritionist final evaluation summarized as optimal or suboptimal by the specialist.
Satisfaction with the multimodal program	Week 4	Satisfaction questionnaire; Scoring scale: 0-45 Higher value indicates higher satisfaction

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Catalonia, Spain