Bladder Carcinoma
Conditions
Keywords
prehabilitation, bladder cancer, exercise, smoking cessation, nutritional support, surgical complications, cystectomy
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.
Interventions
BEHAVIORALPrehabilitation
Multimodal prehabilitation program
Sponsors
UMC Utrecht
University Medical Center Groningen
Radboud University Medical Center
Rijnstate Hospital
Noordwest Ziekenhuisgroep
Erasmus Medical Center
Maastricht University Medical Center
Karolinska Institutet
The Netherlands Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| High grade complications | 0-12 weeks post-surgery | Clavien Dindo grade 3 or higher |
| Duration of hospital stay | 0-12 weeks post-surgery | Time from admission until hospital discharge |
| 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 |
| Change in cardiorespiratory fitness | T0a (baseline), T1 (within 1 week before surgery) | Assessed via cardiopulmonary exercise test (CPET) |
| Change in muscle strength | T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery) | Grip strength |
| Change in physical performance | T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery) | Short Physical Performance Battery (SPPB) |
| 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 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) |
| Nil per mouth consumption during hospitalization | 0-12 weeks post-surgery | The total days as recorded in medical file |
| 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 |
| 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 |
| Non participation analysis | T0a (baseline) | Identify clinical and sociodemographic variables that are related to non-participation of patients in this trial via 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 |
| Sense of coherence (SOC) | T0a (baseline) | 13-item SOC 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 |
| 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 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 |
| 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 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 |
| 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 |
| Intervention costs | T0a (baseline) - T3 (12 weeks post-surgery) | Cost analysis |
| 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) |
| Work status | T0a (baseline) - T3 (12 weeks post-surgery) | Productivity Cost Questionnaire (iPCQ) |
| Satisfaction with prehabilitation in intervention group and evaluation in control group | T3 (12 weeks post-surgery) | Self-developed questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall and bladder-cancer specific survival | 0-60 months | Exploratory outcome |
| Progression-free survival | 0-60 months | Exploratory outcome |
Countries
Netherlands
Contacts
Primary ContactMartijn Stuiver, PhD
Backup ContactEmine Akdemir, MSc
Outcome results
None listed