Prostate Cancer, Radical Prostatectomy
Conditions
Keywords
Prehabilitation, Robotic-assisted radical prostatectomy
Brief summary
The aim of the study is to verify whether a multimodal prehabilitation program prior to robotic-assisted radical prostatectomy (RARC) contributes to a faster recovery of quality of life after surgery.
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.
Interventions
BEHAVIORALMultimodal prehabilitation
Patients randomized to the intervention group participated in a structured, four-week multimodal prehabilitation program, initiated immediately after the baseline assessment. The program was delivered by a multidisciplinary prehabilitation team. The program consisted of the following components lead by specialists: 1. Physical activity: aerobic/resistance exercises 45-60min x 2-3 times per week (adapted by a personal trainer), encouraged to walk 7500 steps daily 2. Pelvic floor muscle training: a structured PFMT program, introduced and supervised by a physiotherapist during baseline assessment and unsupervised with written instructions for home practice 3. Nutritional optimization: weekly group sessions led by a dietitian and supplementation was tailored to individuals needs. 4. Psychological Support: weekly 60-minute group sessions based on mindfulness-based stress reduction led by a psychologist
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Eligible patients: * Men aged ≥18 years * Histologically confirmed localized or locally advanced prostate cancer - Scheduled for robotic-assisted radical prostatectomy (RARP).
Exclusion criteria
* Metastatic disease * Prior treatment for prostate cancer (e.g., brachytherapy, radiotherapy), - Significant cardiopulmonary comorbidities contraindicating physical activity * Declining consent * Patients referred from hospitals outside our city were also excluded (to ensure consistent adherence to the prehabilitation program at nearby fitness centers).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early postoperative HRQoL | From baseline to 1 month after RARP | The change in the global health status domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional HRQoL domains of the EORTC QLQ-C30 | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months | Additional HRQoL domains of the EORTC QLQ-C30 |
| Mental health | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months | Hospital Anxiety and Depression Scale (HADS) |
| Physical performance | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months | 6-minute walk test (6MWT) |
| Functional recovery | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months | Urinary continence using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) |
| Erectile Function | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months | Index of Erectile Function-5 (IIEF-5) |
| Disease-specific HRQoL | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months | EORTC QLQ-PR25 |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORAntoni Vilaseca, Dr
Clinic
Outcome results
None listed