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PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)

Erasmus University logo

Erasmus University

Status

Enrolling

Conditions

Cancer Head Neck
Cancer Liver

Treatments

Behavioral: Prehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT05745558
NL 80823.078.22

Details and patient eligibility

About

The objective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with head and neck cancer or liver cancer. Participating patients will participate in a 3-to-6 week rehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.

Full description

In patients diagnosed with head and neck cancer (HNC) or liver cancer, (major) surgery is the standard of care. Nevertheless, surgery may result in complications that have a substantial impact on the physical and psychological state of the patient. Detrimental postoperative outcomes are influenced by unhealthy lifestyle behaviors such as a sedentary lifestyle, smoking and malnutrition. Prehabilitation programs focusing on these lifestyle aspects have been suggested as a promising intervention to improve pre- and postoperative outcomes. Therefore, the obective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with HNC or liver cancer

This study concerns a prospective cohort study in 60 patients with HNC or liver cancer that participate in a 3 to 6-week pilot prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.

Data on feasibility (program satisfaction, program compliance and percentage of patients willing to participate in the prehabilitation program) and effectiveness (e.g. complications, health status, compliance to healthy lifestyle) is collected at three time points (pre- and post the prehabilitation program and 30 days post-surgery).

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥18 years
  • Diagnosis of head and neck cancer or liver cancer
  • Scheduled for surgery in Erasmus MC
  • Provision of written informed consent
  • Only patient with a waiting time of at least 3 weeks till surgery can participate in this study

Exclusion criteria

  • Patients that do not understand the Dutch language
  • Patients with severe physical or psychological comorbidities that limit participation in the prehabilitation program

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Prehabilitation
Experimental group
Description:
A 3-to-6-week prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.
Treatment:
Behavioral: Prehabilitation

Trial contacts and locations

1

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Central trial contact

Nienke ter Hoeve, PhD

Data sourced from clinicaltrials.gov

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