EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy (ENHANCE)
Bladder Carcinoma
About this trial
This is an interventional treatment trial for Bladder Carcinoma focused on measuring prehabilitation, bladder cancer, exercise, smoking cessation, nutritional support, surgical complications, cystectomy
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0),
- Planned to undergo radical cystectomy,
- Age ≥ 18 years.
Exclusion Criteria:
- Subjects with severe cognitive or psychiatric disorders,
- Subjects who are operated within 3 weeks,
- Subjects with insufficient command of the Dutch language, which precludes them from following study instructions or completing study questionnaires,
- Subjects who have contraindications to safely perform exercise training or testing (i.e., CPET),
- Subject who are unable or unwilling to participate in the intervention.
Sites / Locations
- Erasmus Medical CenterRecruiting
- RadboudumcRecruiting
- UMC GroningenRecruiting
- UMC UtrechtRecruiting
- Catharina ZiekenhuisRecruiting
- Maastricht UMC+Recruiting
- RijnstateRecruiting
- Noordwest ZiekenhuisgroepRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Prehabilitation group
Control group
The intervention group will participate in a prehabilitation program of approximately 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. A dietician will provide nutritional support and give dietary advice to increase protein intake, including a supplement containing 30 g of whey-protein daily and after supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychologist. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation.
Patients randomized to the control group will receive care as usual according to local ERAS guideline implementation. In addition, they will receive a leaflet with the recent guidelines regarding physical activity, dietary advice, and smoking cessation. Their actual physical activity level will be obtained via questionnaire.