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

Erasmus Medical Center60 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cancer Liver Cancer Head Neck

Interventions

PrehabilitationBEHAVIORAL

The prehabilitation program consists of 4 components: 1. Fitness training led by a physiotherapist. The patients will receive personalized training schedules to perform at home. The training sessions focus on improving aerobic fitness (biking or walking) and muscle strength (specific exercises for the different patient groups) and respiratory exercises aimed to relax. 2. Nutritional counseling led by a dietician. All patients will be offered an intake with a dietician (60 min) to discuss current eating habits and give personalized advices. Based on indication, patients will receive follow-up consults. 3. Smoking cessation counseling led by a trained social worker. For patients that are currently smoking, a social worker will offer counseling sessions to coach the patient in the process of smoking cessation. 4. Psychosocial counseling led by a psychologist. All patients will be offered counselling by a psychologist.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

ErasmusMC

Rotterdam, South Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Program satisfaction

Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)

Time frame: At completion of the prehabilitation program (3-6 weeks after baseline)

Program compliance

Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.

Time frame: At completion of the prehabilitation program (3-6 weeks after baseline)

Percentage of patients willing to participate in prehabilitation program

It will be registered which patient are willing and not willing to participate

Time frame: At completion of the prehabilitation program (3-6 weeks after baseline)

Secondary Outcomes

Frailty

Groningen Frailty Score questionnaire score: score of 0-15, a GFI score of four or greater is considered the cut-off point for frailty

Time frame: Outcomes will be collected twice: at baseline and at completion of the prehabilitation program (3-6 weeks after baseline)

Functional capacity

6-minute walk test: meters walked in 6 minutes time

Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)

Physical activity level

ActiGraph GTx3+ accelerometer: average time per day (min) spend in moderate-to-vigorous activity, light physical activity and sedentary behaviour

Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)

Central Contacts

Nienke ter Hoeve, PhD

CONTACT

0031107044599 n.terhoeve@erasmusmc.nl

Data from ClinicalTrials.gov

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