Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy.
Study Details
Study Description
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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control
|
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| Experimental: Multimodal prehabilitation
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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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Secondary Outcome Measures
- 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.
- 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.
- 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.
- 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
- 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
- Early postoperative morbidity by CCI [Week 8 (post-op)]
Comprehensive Complications Index (CII) Scoring scale: 0-100 Higher value indicates more severe complication
- 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
- Satisfaction with the multimodal program [Week 4]
Satisfaction questionnaire Scoring scale: 0-45 Higher value indicates higher satisfaction
- Nutritional status [Week 0 and 4]
Nutritionist final evaluation summarized as optimal or suboptimal by the specialist.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with localized prostate cancer
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Candidates to robotic radical prostatectomy
Exclusion Criteria:
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Non-localized prostate cancer
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Previous history of pelvic radiotherapy or pelvic surgery
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Failure to consent,
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Unwillingness to participate
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Anticipated failure to adhere to the program sessions.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinic de Barcelona | Barcelona | Catalonia | Spain | 08036 |
Sponsors and Collaborators
- Hospital Clinic of Barcelona
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCB/2021/0289