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

NCT05745558 | Unknown

• 1 other identifier: NL 80823.078.22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Liver; Cancer Head Neck

Outcome Measures

Primary Outcomes (3)

• Program satisfaction

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

  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.

  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

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

Secondary Outcomes (22)

• Frailty

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

• Functional capacity

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

• Physical activity level

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

• Hand grip strength

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

• Quadriceps strength

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

Study Arms (1)

Prehabilitation

EXPERIMENTAL

A 3-to-6-week prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.

Behavioral: Prehabilitation

Interventions

Prehabilitation BEHAVIORAL

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.

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Rijndam Revalidatiecentrum: collaborator
• Capri Hartrevalidatie: collaborator

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3000CA, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Head and Neck Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Nienke ter Hoeve, PhD

CONTACT

0031107044599; n.terhoeve@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective Cohort Study

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 27, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)