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

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

NCT ID: NCT05745558

Condition: Cancer Liver
Cancer Head Neck

Conditions: Official terms:
Head and Neck Neoplasms
Liver Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Prospective Cohort Study

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Prehabilitation
Description: 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.
Arm group label: Prehabilitation

Summary: 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.

Detailed 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).

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: ErasmusMC

Address:
City: Rotterdam
Zip: 3000CA
Country: Netherlands

Status: Recruiting

Contact:
Last name: Nienke ter Hoeve, PhD

Phone: +31107044599
Email: n.terhoeve@erasmusmc.nl

Start date: April 1, 2023

Completion date: July 2025

Lead sponsor:
Agency: Erasmus Medical Center
Agency class: Other

Collaborator:
Agency: Rijndam Revalidatiecentrum
Agency class: Other

Collaborator:
Agency: Capri Hartrevalidatie
Agency class: Other

Source: Erasmus Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05745558