Cancer rehabilitation for Hepato-Pancreato-Biliary cancer patients undergoing surgical treatment

Completed

Conditions: frailty
increased vulnerability towards stressors
10017990
10027656

Registration Number: NL-OMON46733

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 154

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

- 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 <15 kg2/m2, >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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>General fatigue, assessed with the Multidimensional Fatigue Inventory (MFI).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are quality of life, cardiopulmonary fitness, skeletal<br /><br>muscle mass and strength, frailty, anxiety, depression, performance status, and<br /><br>body weight. Furthermore, overall survival will be assessed.</p><br>