Clinical trial NCT05745558: PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
Official title: PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Liver
Cancer Head Neck
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Rijndam Revalidatiecentrum
name: Capri Hartrevalidatie
First posted: 2023-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort Study
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Program satisfaction
timeFrame: At completion of the prehabilitation program (3-6 weeks after baseline)
measure: Program compliance
timeFrame: At completion of the prehabilitation program (3-6 weeks after baseline)
measure: Percentage of patients willing to participate in prehabilitation program
timeFrame: At completion of the prehabilitation program (3-6 weeks after baseline)
Secondary outcomes:
measure: Frailty
timeFrame: Outcomes will be collected twice: at baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Functional capacity
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Physical activity level
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Hand grip strength
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Quadriceps strength
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Nutritional status
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Body composition
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Health status
timeFrame: At baseline, at completion of the prehabilitation program (3-6 weeks after baseline), 30 days post surgery
measure: Anxiety and Depression
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Self-efficacy
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Self-reported smoking behaviour
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Smoking behaviour
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Alcohol consumptiom
timeFrame: At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)
measure: Length of hospital stay
timeFrame: 30 days post surgery
measure: Complications Clavien Dindo grade ≥3 in first 30 days
timeFrame: 30 days post surgery
measure: Readmission rate in first 30 days
timeFrame: 30 days post surgery
measure: Age
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Medical diagnosis
timeFrame: Baseline
measure: Educational level
timeFrame: Baseline
measure: Marital status
timeFrame: Baseline
measure: Work status
timeFrame: Baseline
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: ErasmusMC
state: South Holland
Study officials:
References: