frailty increased vulnerability towards stressors
Conditions
Interventions
rehabilitation program consisting of physical exercise therapy, psychotherapy
and dietary consultation.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Undergoing curative intent surgery for HPB malignancies. Liver surgery will be defined as major if a left or right (extended) hemihepatectomy or if 3 or more segments are resected and minor if less than 3 segments are resected. * Clinically suspect or histologically confirmed liver, bile duct, pancreatic carcinoma or invasive IPMN; * Life expectancy of at least six (6) months; * Resection performed * Fatigue score * 4 on a numeric rating scale (NRS) with scores of 0 to 10 * Able to read and understand the Dutch language; * Written informed consent.
Exclusion criteria
Exclusion criteria: - Bone metastases or other high risk of fracture; - Not able to perform basic activities of daily living (ECOG *3); - Decompensated heart disease, uncontrolled hypertension (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg), heart failure (NYHA Class II or greater) or chronic obstructive pulmonary disease causing fatigue; - Living in nursing homes; - Cognitive impairment; - BMI 5% weight loss per month or other health problems that would not allow physical exercise training; - Anxiety or depression requiring psychiatric consultation; - Cancer treatment in the previous 3 years (except basal skin cancer); - Participation in other studies containing elements of physical exercise or psychological therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| General fatigue, assessed with the Multidimensional Fatigue Inventory (MFI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are quality of life, cardiopulmonary fitness, skeletal muscle mass and strength, frailty, anxiety, depression, performance status, and body weight. Furthermore, overall survival will be assessed. | — |
Countries
Netherlands
Outcome results
None listed