EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0),

• Planned to undergo radical cystectomy,

• Age ≥ 18 years.

Locations
Other Locations
Netherlands
Noordwest Ziekenhuisgroep
RECRUITING
Alkmaar
Rijnstate
RECRUITING
Arnhem
Catharina Ziekenhuis
RECRUITING
Eindhoven
UMC Groningen
RECRUITING
Groningen
Maastricht UMC+
RECRUITING
Maastricht
Radboudumc
RECRUITING
Nijmegen
Erasmus Medical Center
RECRUITING
Rotterdam
UMC Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Martijn Stuiver, PhD
m.stuiver@nki.nl
+31205124136
Backup
Emine Akdemir, MSc
e.akdemir@nki.nl
+31683395101
Time Frame
Start Date: 2022-08-11
Estimated Completion Date: 2025-10
Participants
Target number of participants: 154
Treatments
Experimental: Prehabilitation 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.
No_intervention: Control group
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.
Related Therapeutic Areas
Sponsors
Collaborators: UMC Utrecht, University Medical Center Groningen, Karolinska Institutet, Noordwest Ziekenhuisgroep, Radboud University Medical Center, Maastricht University Medical Center, Erasmus Medical Center, Rijnstate Hospital
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov