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Cancer Rehabilitation in hepato-pancreato-biliary cancer patients undergoing Surgical Treatment.

Cancer Rehabilitation in hepato-pancreato-biliary cancer patients undergoing Surgical Treatment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21906
Enrollment
154
Registered
2018-03-28
Start date
2018-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepato-pancreato-biliary cancer, HPB, fatigue, quality of life, muscle mass, rehabilitation.

Interventions

Physical therapy: Every week 2x 2hr for 12 weeks, At home Solution Focused Therapy: Every other week 1x 1hr for 12 weeks. Diatary support: if at risk for malnutrition

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

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 or pancreatic carcinoma; • Life expectancy of at least six (6) months; • 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: • Treatment with adjuvant chemo(radiation)therapy • Bone metastases or other high risk of fractures; • 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 5 years (except basal skin cancer); • Participation in other studies containing elements of physical exercise or psychological therapy.

Design outcomes

Primary

MeasureTime frame
MFI-20 General Fatigue at 12 months after surgery

Secondary

MeasureTime frame
MFI-20, Quality of life, Frailty, Anxiety and Depression, physical status, activity level, survival, cost-utility

Contacts

Public ContactB. Beumer
b.beumer@erasmusmc.nl06 361 446 32

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)