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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553327
• Other study ID #: HCB/2021/0289
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: November 2023
• Source: Hospital Clinic of Barcelona
• Contact: Antoni Vilaseca, Dr
• Phone: 932 275 400
• Email: avilasec[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Early postoperative morbidity by CDC	Clavien-Dindo Classification (CDC); Scoring scale: 1-5 Higher value indicates more severe complication	Week 8 (post-op)
Secondary	Early postoperative morbidity by CCI	Comprehensive Complications Index (CII); Scoring scale: 0-100 Higher value indicates more severe complication	Week 8 (post-op)
Secondary	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
Secondary	Satisfaction with the multimodal program	Satisfaction questionnaire; Scoring scale: 0-45 Higher value indicates higher satisfaction	Week 4
Secondary	Nutritional status	Nutritionist final evaluation summarized as optimal or suboptimal by the specialist.	Week 0 and 4