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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05745558
Other study ID # NL 80823.078.22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date July 2025

Study information

Verified date May 2023
Source Erasmus Medical Center
Contact Nienke ter Hoeve, PhD
Phone 0031107044599
Email n.terhoeve@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Participating patients will participate in a 3-to-6 week rehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Netherlands ErasmusMC Rotterdam South Holland

Sponsors (3)

Lead Sponsor Collaborator
Erasmus Medical Center Capri Hartrevalidatie, Rijndam Revalidatiecentrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary Hand grip strength Hand dynamometer (kg) At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Secondary 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)
Secondary 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)
Secondary Body composition Weight scale (kg) At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Secondary 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
Secondary 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)
Secondary 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)
Secondary Self-reported smoking behaviour Self-designed questionnaire (smoking yes/no) At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Secondary Smoking behaviour carbon monoxide breath analyser (CO ppm + % COhb) At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
Secondary 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)
Secondary Length of hospital stay Registrered in patient file (length in days) 30 days post surgery
Secondary Complications Clavien Dindo grade =3 in first 30 days Registrered in patient file (number of complications and clavien dindo grade) 30 days post surgery
Secondary Readmission rate in first 30 days Number and reason for readmissions in first 30 days 30 days post surgery
Secondary Age Age in years Baseline
Secondary Sex Female/male/other Baseline
Secondary Medical diagnosis Medical diagnosis for surgery Baseline
Secondary Educational level Single-item question (high, middle, low educated) Baseline
Secondary Marital status Single-item question (Partnered/ unpartnered) Baseline
Secondary Work status Single-item question (employed/unemployed) Baseline
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