Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases (HQOL)

Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases A Prospective Multicenter Study

The purpose of this trial is to study health related quality of life (HQoL)after resection of colorectal liver metastases combined with perioperative chemotherapy. The investigators want to study if an aggressive, life prolonging and multimodal treatment can be defended from a quality of life perspective.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Metastasis

Detailed Description

Background: Hepatic resection is the only treatment with potential curative intent for patients having colorectal liver metastases. Combined with chemotherapy, the overall 5-year survival is 40-50%. The disease free 5-year survival is about 20%, and about 70% of resected patients experience recurrence from their disease. Even if surgery is superior all other treatments, most patients will finally die from their cancer. However; surgery contributes by adding years of life, and for a minority, a disease free life. There has been much effort to study predictors for outcome after surgery, but little has been focused on quality of life following this treatment.

Method: EORTC Validated questionnaire (European Organisation Research of Treatment of Cancer) version QLQ-C30 (3.0) and QLQ LMC21. The patients fill out the questionnaire before surgery as a baseline, and then after 3,6 and 12 months after surgery. The investigators also register important clinicopathological data about each patient prospectively.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jon-Helge Angelsen, MD; Phone Number: +4797520572; Email: jhangelsen@gmail.com
• Study Contact Backup: Name: Asgaut Viste, Professor; Phone Number: +5755972760; Email: asgaut.viste@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, N-5020
    • Recruiting
    • Departement of acute and digestive surgery, surgical clinic, Haukeland University Hospital
    • Contact: Arild Horn, MD, PhD; Phone Number: +4755972797; Email: arild.horn@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with resectable colorectal liver metastases treated at Haukeland and Stavanger University hospital, Norway.

Description

Inclusion Criteria:

• Liver metastasis from colorectal cancer
• Resectability, with intension of R0 resection
• No macroscopic tumor left after surgery
• Patients with combined resectable extrahepatic tumors are also included.
• Patients must complete the questionnaire before the operation.

Exclusion Criteria:

• Drop out of questionnaire after surgery
• Patients found to be irresectable during the operation or where macroscopic tumor tissue are left behind.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life after liver resection in combination with chemotherapy	The EORTC board has made validated questionaries with manuals for measuring quality of life. The important focus is to see if and when patients gain their HQoL as they did have before surgery.	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying possible clinical parameters influencing the HQoL after liver resection.	Examples of parameters: complications, extent of surgery, chemotherapy.	Up to one year after surgery, maybe longer

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Helse Stavanger HF
• Investigators: Study Director: August Bakke, Professor, Director, Surgical clinic, Haukeland University Hospital, Helse-Bergen HF, N-5020 Bergen, Norway

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: surveillance; Health related quality of life; Colorectal liver metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 2011/570