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

Primary Purpose

Cancer Liver, Cancer Head Neck

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ErasmusMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prehabilitation

Arm Description

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

Outcomes

Primary Outcome Measures

Program satisfaction
Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)
Program compliance
Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.
Percentage of patients willing to participate in prehabilitation program
It will be registered which patient are willing and not willing to participate

Secondary Outcome Measures

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
Functional capacity
6-minute walk test: meters walked in 6 minutes time
Physical activity level
ActiGraph GTx3+ accelerometer: average time per day (min) spend in moderate-to-vigorous activity, light physical activity and sedentary behaviour
Hand grip strength
Hand dynamometer (kg)
Quadriceps strength
Biodex dynamometer (Peak torque to body weight extension + Work fatigue)
Nutritional status
Short Nutritional Assessment Questionnaire (SNAQ) score (range 4-20, lower score means higher risk of malnutrition)
Body composition
Weight scale (kg)
Health status
EuroQol-5D (EQ5D) questionnaire score (0-1, the maximum score of 1 indicates the best health state)
Anxiety and Depression
Hospital Anxiety and Depression Scale questionnaire score (0-21, higher scores denotes risk of anxiety or depression
Self-efficacy
General Self Efficacy Scale questionnaire score (10-40, with a higher score indicating more self-efficacy
Self-reported smoking behaviour
Self-designed questionnaire (smoking yes/no)
Smoking behaviour
carbon monoxide breath analyser (CO ppm + % COhb)
Alcohol consumptiom
Five shot questionnaire score (0-7, a higher score indicates possible alcohol misuse)
Length of hospital stay
Registrered in patient file (length in days)
Complications Clavien Dindo grade ≥3 in first 30 days
Registrered in patient file (number of complications and clavien dindo grade)
Readmission rate in first 30 days
Number and reason for readmissions in first 30 days
Age
Age in years
Sex
Female/male/other
Medical diagnosis
Medical diagnosis for surgery
Educational level
Single-item question (high, middle, low educated)
Marital status
Single-item question (Partnered/ unpartnered)
Work status
Single-item question (employed/unemployed)

Full Information

First Posted
February 6, 2023
Last Updated
May 9, 2023
Sponsor
Erasmus Medical Center
Collaborators
Rijndam Revalidatiecentrum, Capri Hartrevalidatie
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1. Study Identification

Unique Protocol Identification Number
NCT05745558
Brief Title
PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
Acronym
PREPARE
Official Title
PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Rijndam Revalidatiecentrum, Capri Hartrevalidatie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Liver, Cancer Head Neck

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Cohort Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nienke ter Hoeve, PhD
Phone
0031107044599
Email
n.terhoeve@erasmusmc.nl
Facility Information:
Facility Name
ErasmusMC
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3000CA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nienke ter Hoeve, PhD
Phone
+31107044599
Email
n.terhoeve@erasmusmc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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

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