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

Sponsor
Erasmus Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05745558
Collaborator
Rijndam Revalidatiecentrum (Other), Capri Hartrevalidatie (Other)
60
1
27

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Prehabilitation
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective Cohort StudyProspective Cohort Study
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Program satisfaction [At completion of the prehabilitation program (3-6 weeks after baseline)]

    Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)

  2. Program compliance [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.

  3. Percentage of patients willing to participate in prehabilitation program [At completion of the prehabilitation program (3-6 weeks after baseline)]

    It will be registered which patient are willing and not willing to participate

Secondary Outcome Measures

  1. Frailty [Outcomes will be collected twice: at baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    Groningen Frailty Score questionnaire score: score of 0-15, a GFI score of four or greater is considered the cut-off point for frailty

  2. Functional capacity [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    6-minute walk test: meters walked in 6 minutes time

  3. Physical activity level [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    ActiGraph GTx3+ accelerometer: average time per day (min) spend in moderate-to-vigorous activity, light physical activity and sedentary behaviour

  4. Hand grip strength [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    Hand dynamometer (kg)

  5. Quadriceps strength [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    Biodex dynamometer (Peak torque to body weight extension + Work fatigue)

  6. Nutritional status [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    Short Nutritional Assessment Questionnaire (SNAQ) score (range 4-20, lower score means higher risk of malnutrition)

  7. Body composition [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    Weight scale (kg)

  8. Health status [At baseline, at completion of the prehabilitation program (3-6 weeks after baseline), 30 days post surgery]

    EuroQol-5D (EQ5D) questionnaire score (0-1, the maximum score of 1 indicates the best health state)

  9. Anxiety and Depression [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    Hospital Anxiety and Depression Scale questionnaire score (0-21, higher scores denotes risk of anxiety or depression

  10. Self-efficacy [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    General Self Efficacy Scale questionnaire score (10-40, with a higher score indicating more self-efficacy

  11. Self-reported smoking behaviour [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    Self-designed questionnaire (smoking yes/no)

  12. Smoking behaviour [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    carbon monoxide breath analyser (CO ppm + % COhb)

  13. Alcohol consumptiom [At baseline and at completion of the prehabilitation program (3-6 weeks after baseline)]

    Five shot questionnaire score (0-7, a higher score indicates possible alcohol misuse)

  14. Length of hospital stay [30 days post surgery]

    Registrered in patient file (length in days)

  15. Complications Clavien Dindo grade ≥3 in first 30 days [30 days post surgery]

    Registrered in patient file (number of complications and clavien dindo grade)

  16. Readmission rate in first 30 days [30 days post surgery]

    Number and reason for readmissions in first 30 days

  17. Age [Baseline]

    Age in years

  18. Sex [Baseline]

    Female/male/other

  19. Medical diagnosis [Baseline]

    Medical diagnosis for surgery

  20. Educational level [Baseline]

    Single-item question (high, middle, low educated)

  21. Marital status [Baseline]

    Single-item question (Partnered/ unpartnered)

  22. Work status [Baseline]

    Single-item question (employed/unemployed)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Erasmus Medical Center
  • Rijndam Revalidatiecentrum
  • Capri Hartrevalidatie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roeland F. de Wilde, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT05745558
Other Study ID Numbers:
  • NL 80823.078.22
First Posted:
Feb 27, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2023