NCT05480735

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

August 11, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

July 14, 2022

Last Update Submit

October 27, 2022

Conditions

Bladder Carcinoma

Keywords

prehabilitationbladder cancerexercisesmoking cessationnutritional supportsurgical complicationscystectomy

Outcome Measures

Primary Outcomes (1)

  • Complications

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

    0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)

Secondary Outcomes (27)

  • High grade complications

    0-12 weeks post-surgery

  • Duration of hospital stay

    0-12 weeks post-surgery

  • Readmissions

    0-12 weeks post-surgery

  • Disease status

    0-12 weeks post-surgery

  • Change in cardiorespiratory fitness

    T0a (baseline), T1 (within 1 week before surgery)

  • +22 more secondary outcomes

Other Outcomes (2)

  • Overall and bladder-cancer specific survival

    0-60 months

  • Progression-free survival

    0-60 months

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

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.

Behavioral: Prehabilitation

Control group

NO INTERVENTION

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.

Interventions

PrehabilitationBEHAVIORAL

Multimodal prehabilitation program

Prehabilitation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0),
  • Planned to undergo radical cystectomy,
  • Age ≥ 18 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Erasmus Medical Center

Rotterdam, Doctor Molewaterplein 40, 3015 GD, Netherlands

RECRUITING

Radboudumc

Nijmegen, Geert Grooteplein Zuid 10, 6525 GA, Netherlands

RECRUITING

UMC Groningen

Groningen, Hanzeplein 1, 9713 GZ, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Heidelberglaan 100, 3584 CX, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, Michelangelolaan 2, 5623 EJ, Netherlands

RECRUITING

Maastricht UMC+

Maastricht, P. Debyelaan 25, 6229 HX, Netherlands

RECRUITING

Rijnstate

Arnhem, Wagnerlaan 55, 6815 AD, Netherlands

RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, Wilhelminalaan 12, 1815 JD, Netherlands

RECRUITING

Related Publications (1)

  • Akdemir E, Sweegers MG, Vrieling A, Rundqvist H, Meijer RP, Leliveld-Kors AM, van der Heijden AG, Rutten VC, Koldewijn EL, Bos SD, Wijburg CJ, Marcelissen TAT, Bongers BC, Retel VP, van Harten WH, May AM, Groen WG, Stuiver MM. EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial. BMJ Open. 2023 Mar 7;13(3):e071304. doi: 10.1136/bmjopen-2022-071304.

    PMID: 36882246DERIVED

MeSH Terms

Conditions

Urinary Bladder NeoplasmsMotor ActivitySmoking Cessation

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Martijn Stuiver, PhD

CONTACT

+31205124136m.stuiver@nki.nl

Emine Akdemir, MSc

CONTACT

+31683395101e.akdemir@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 29, 2022

Study Start

August 11, 2022

Primary Completion

December 1, 2024

Study Completion

October 1, 2025

Last Updated

October 31, 2022

Record last verified: 2022-10

Locations

NL(8)