Cancer LiverPREPARENCT05745558
PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
A study testing Prehabilitation in people with Cancer Liver and Cancer Head Neck, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Liver, Cancer Head Neck
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients that do not understand the Dutch language
- Patients with severe physical or psychological comorbidities that limit participation in the prehabilitation program
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
ErasmusMC
Rotterdam, South Holland, 3000CA
Nienke ter Hoeve, PhD, +31107044599, n.terhoeve@erasmusmc.nl
About this study
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.
Read the 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).
- Conditions
- Cancer Liver, Cancer Head Neck
- Being tested
- Prehabilitation
- Medical subject headings
- Carcinoma, Hepatocellular, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | A 3-to-6-week prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling. Receives: Behavioral: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program satisfaction
Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)
Measured: 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.
Measured: 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
Measured: At completion of the prehabilitation program (3-6 weeks after baseline)
Secondary outcomes (22)
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
Measured: 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
Measured: 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
Measured: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Hand grip strength
Hand dynamometer (kg)
Measured: 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)
Measured: 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)
Measured: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Body composition
Weight scale (kg)
Measured: 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)
Measured: 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
Measured: 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
Measured: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Self-reported smoking behaviour
Self-designed questionnaire (smoking yes/no)
Measured: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Smoking behaviour
carbon monoxide breath analyser (CO ppm + % COhb)
Measured: 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)
Measured: 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)
Measured: 30 days post surgery
Complications Clavien Dindo grade ≥3 in first 30 days
Registrered in patient file (number of complications and clavien dindo grade)
Measured: 30 days post surgery
Readmission rate in first 30 days
Number and reason for readmissions in first 30 days
Measured: 30 days post surgery
Age
Age in years
Measured: Baseline
Sex
Female/male/other
Measured: Baseline
Medical diagnosis
Medical diagnosis for surgery
Measured: Baseline
Educational level
Single-item question (high, middle, low educated)
Measured: Baseline
Marital status
Single-item question (Partnered/ unpartnered)
Measured: Baseline
Work status
Single-item question (employed/unemployed)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Apr 2023
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer LiverStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort Study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rijndam Revalidatiecentrum, Capri Hartrevalidatie
- Responsible party
- Principal investigator, Roeland F. de Wilde, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745558
- Sponsor's protocol ID
- NL 80823.078.22
- Acronym
- PREPARE
- Status last verified
- May 2023
- First submitted
- 6 Feb 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
- ClinicalTrials.gov ID
- NCT05745558
- Acronym / sponsor ID
- PREPARE / NL 80823.078.22
- Conditions
- Cancer Liver, Cancer Head Neck
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Rijndam Revalidatiecentrum, Capri Hartrevalidatie
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort Study
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: PrehabilitationA 3-to-6-week prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients that do not understand the Dutch language
- Patients with severe physical or psychological comorbidities that limit participation in the prehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationThe 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. | Behavioural | Prehabilitation |
Primary outcome
Program satisfaction
Time frame: At completion of the prehabilitation program (3-6 weeks after baseline)
Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)
Program compliance
Time frame: At completion of the prehabilitation program (3-6 weeks after baseline)
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
Time frame: At completion of the prehabilitation program (3-6 weeks after baseline)
It will be registered which patient are willing and not willing to participate
22 secondary outcomes
Frailty
Time frame: Outcomes will be collected twice: at baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Functional capacity
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Physical activity level
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Hand grip strength
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Quadriceps strength
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Nutritional status
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Body composition
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Health status
Time frame: At baseline, at completion of the prehabilitation program (3-6 weeks after baseline), 30 days post surgery
Anxiety and Depression
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Self-efficacy
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Self-reported smoking behaviour
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Smoking behaviour
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Alcohol consumptiom
Time frame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Length of hospital stay
Time frame: 30 days post surgery
Complications Clavien Dindo grade ≥3 in first 30 days
Time frame: 30 days post surgery
Readmission rate in first 30 days
Time frame: 30 days post surgery
Age
Time frame: Baseline
Sex
Time frame: Baseline
Medical diagnosis
Time frame: Baseline
Educational level
Time frame: Baseline
Marital status
Time frame: Baseline
Work status
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Cancer Liver and Cancer Head Neck, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nienke ter Hoeve, PhD (0031107044599, n.terhoeve@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program satisfaction (time frame: At completion of the prehabilitation program (3-6 weeks after baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.