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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Multimodal prehabilitation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoni Vilaseca, Dr; Phone Number: 5545 932 275 400; Email: avilasec@clinic.cat

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Recruiting
      • Hospital Clinic de Barcelona
      • Contact: Antoni Vilaseca, Dr; Phone Number: 5545 932275400; Email: avilasec@clinic.cat
      • Principal Investigator: Antoni Vilaseca, Dr
      • Sub-Investigator: Enric Carbonell, Dr
      • Sub-Investigator: Claudia Mercader, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; This group of patients will not receive a pre-hab program
Experimental: Multimodal prehabilitation; This patients will receive the pre-hab program	Behavioral: Multimodal prehabilitation; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Antoni Vilaseca, Dr, Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HCB/2021/0289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No