EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy
- Conditions
- Bladder Carcinoma
- Interventions
- Behavioral: Prehabilitation
- Registration Number
- NCT05480735
- Lead Sponsor
- The Netherlands Cancer Institute
- Brief Summary
Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs.
- Detailed Description
The ENHANCE study is a multicenter, randomized controlled trial. The intervention group will participate in a prehabilitation program of 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The prehabilitation 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. Patients will be asked to be physically active for an additional 2 times a week for at least 30 minutes. A dietician will provide nutritional support and give dietary advice to increase protein intake to enhance the anabolic effect on muscle mass. Additionally, patients will receive a supplement containing 30 g of high quality whey-protein daily preferably before sleep and after the supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychological support. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients in the intervention group will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation. The physical activity level in both groups will be obtained via questionnaire.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 154
- Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0),
- Planned to undergo radical cystectomy,
- Age ≥ 18 years.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation group Prehabilitation 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.
- Primary Outcome Measures
Name Time Method Complications 0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery) The proportion of patients having Clavien-Dindo grade 2 or higher perioperative complications; obtained from the medical records
- Secondary Outcome Measures
Name Time Method Change in nutritional status T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery) Short Form- Patient Generated Subjective Global Assessment (SF-PGSA)
Change in muscle invasive bladder cancer specific scores T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery) EORTC QLQ-BLM30
Duration of hospital stay 0-12 weeks post-surgery Time from admission until hospital discharge
Change in physical performance T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery) Short Physical Performance Battery (SPPB)
Change in muscle strength T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery) 30s chair stands
Change in body composition T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery) Fat free mass and fat mass assessed by Scale Bioelectrical Impedance Analysis (BIA)
Change in weight T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery) Measured in KG
Height T0a (baseline) - T3 (12 weeks post-surgery) Measured in cm
Healthcare resources consumption T0a (baseline) - T3 (12 weeks post-surgery) (measured within 1 week before surgery, 4 and 12 weeks post-surgery and if applicable : after neoadjuvant chemotherapy) Medical Consumption Questionnaire (iMCQ)
Change in cardiorespiratory fitness T0a (baseline), T1 (within 1 week before surgery) Assessed via cardiopulmonary exercise test (CPET)
Work status T0a (baseline) - T3 (12 weeks post-surgery) Productivity Cost Questionnaire (iPCQ)
Readmissions 0-12 weeks post-surgery Hospital readmission as recorded in medical file
Disease status 0-12 weeks post-surgery Progression/recurrence, any additional treatment as recorded in medical file
Nil per mouth consumption during hospitalization 0-12 weeks post-surgery The total days as recorded in medical file
Change in smoking status T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery) Self-developed questionnaire
Change in fatigue T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery) MFI questionnaire
High grade complications 0-12 weeks post-surgery Clavien Dindo grade 3 or higher
Intervention costs T0a (baseline) - T3 (12 weeks post-surgery) Cost analysis
Sense of coherence (SOC) T0a (baseline) 13-item SOC questionnaire
Change in HRQoL T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery) EORTC QLQ-C30
Change in physical activity T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery) SQUASH questionnaire
Hypoxia T3 (12 weeks post-surgery) To study the effectiveness of the prehabilitation program in terms of inducing favorable changes in tumor hypoxia markers
Change in health status T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery) EQ-5D-5L
Change in anxiety and depression T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery) HADS questionnaire
Satisfaction with prehabilitation in intervention group and evaluation in control group T3 (12 weeks post-surgery) Self-developed questionnaire
Non participation analysis T0a (baseline) Identify clinical and sociodemographic variables that are related to non-participation of patients in this trial via questionnaire
Trial Locations
- Locations (8)
UMC Groningen
🇳🇱Groningen, Hanzeplein 1, Netherlands
UMC Utrecht
🇳🇱Utrecht, Heidelberglaan 100, Netherlands
Maastricht UMC+
🇳🇱Maastricht, P. Debyelaan 25, Netherlands
Rijnstate
🇳🇱Arnhem, Wagnerlaan 55, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Doctor Molewaterplein 40, Netherlands
Radboudumc
🇳🇱Nijmegen, Geert Grooteplein Zuid 10, Netherlands
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Wilhelminalaan 12, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Michelangelolaan 2, Netherlands