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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Head Neck; Cancer Liver
• Intervention / Treatment: Behavioral: Prehabilitation

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nienke ter Hoeve, PhD; Phone Number: 0031107044599; Email: n.terhoeve@erasmusmc.nl

Study Locations

• Netherlands
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3000CA
      • Recruiting
      • ErasmusMC
      • Contact: Nienke ter Hoeve, PhD; Phone Number: +31107044599; Email: n.terhoeve@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: Prehabilitation; The prehabilitation program consists of 4 components: 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.; 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.; 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.; Psychosocial counseling led by a psychologist. All patients will be offered counselling by a psychologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age in years	Baseline
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	Outcomes will be collected twice: at baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Length of hospital stay	Registrered in patient file (length in days)	30 days post surgery
Complications Clavien Dindo grade ≥3 in first 30 days	Registrered in patient file (number of complications and clavien dindo grade)	30 days post surgery
Readmission rate in first 30 days	Number and reason for readmissions in first 30 days	30 days post surgery
Sex	Female/male/other	Baseline
Medical diagnosis	Medical diagnosis for surgery	Baseline
Educational level	Single-item question (high, middle, low educated)	Baseline
Marital status	Single-item question (Partnered/ unpartnered)	Baseline
Work status	Single-item question (employed/unemployed)	Baseline
Functional capacity	6-minute walk test: meters walked in 6 minutes time	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	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Hand grip strength	Hand dynamometer (kg)	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Quadriceps strength	Biodex dynamometer (Peak torque to body weight extension + Work fatigue)	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Nutritional status	Short Nutritional Assessment Questionnaire (SNAQ) score (range 4-20, lower score means higher risk of malnutrition)	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Body composition	Weight scale (kg)	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Health status	EuroQol-5D (EQ5D) questionnaire score (0-1, the maximum score of 1 indicates the best health state)	At baseline, at completion of the prehabilitation program (3-6 weeks after baseline), 30 days post surgery
Anxiety and Depression	Hospital Anxiety and Depression Scale questionnaire score (0-21, higher scores denotes risk of anxiety or depression	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Self-efficacy	General Self Efficacy Scale questionnaire score (10-40, with a higher score indicating more self-efficacy	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Self-reported smoking behaviour	Self-designed questionnaire (smoking yes/no)	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Smoking behaviour	carbon monoxide breath analyser (CO ppm + % COhb)	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Alcohol consumptiom	Five shot questionnaire score (0-7, a higher score indicates possible alcohol misuse)	At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Rijndam Revalidatiecentrum; Capri Hartrevalidatie

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Head and Neck Neoplasms; Liver Neoplasms
• Other Study ID Numbers: NL 80823.078.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No