EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy

The Netherlands Cancer Institute154 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

Erasmus Medical Center

Rotterdam, Doctor Molewaterplein 40, Netherlands

RECRUITING

Radboudumc

Nijmegen, Geert Grooteplein Zuid 10, Netherlands

RECRUITING

UMC Groningen

Groningen, Hanzeplein 1, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Heidelberglaan 100, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, Michelangelolaan 2, Netherlands

RECRUITING

Maastricht UMC+

Maastricht, P. Debyelaan 25, Netherlands

RECRUITING

Rijnstate

Arnhem, Wagnerlaan 55, Netherlands

RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, Wilhelminalaan 12, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Complications

The proportion of patients having Clavien-Dindo grade 2 or higher perioperative complications; obtained from the medical records

Time frame: 0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)

Secondary Outcomes

High grade complications

Clavien Dindo grade 3 or higher

Time frame: 0-12 weeks post-surgery

Duration of hospital stay

Time from admission until hospital discharge

Time frame: 0-12 weeks post-surgery

Readmissions

Hospital readmission as recorded in medical file

Time frame: 0-12 weeks post-surgery

Disease status

Progression/recurrence, any additional treatment as recorded in medical file

Time frame: 0-12 weeks post-surgery

Change in cardiorespiratory fitness

Assessed via cardiopulmonary exercise test (CPET)

Time frame: T0a (baseline), T1 (within 1 week before surgery)

Change in muscle strength

Grip strength

Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)

Change in muscle strength

30s chair stands

Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)

Change in physical performance

Short Physical Performance Battery (SPPB)

Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)

Change in nutritional status

Short Form- Patient Generated Subjective Global Assessment (SF-PGSA)

Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)

Change in body composition

Fat free mass and fat mass assessed by Scale Bioelectrical Impedance Analysis (BIA)

Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)

Nil per mouth consumption during hospitalization

The total days as recorded in medical file

Time frame: 0-12 weeks post-surgery

Change in weight

Measured in KG

Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)

Height

Measured in cm

Time frame: T0a (baseline) - T3 (12 weeks post-surgery)

Change in smoking status

Self-developed questionnaire