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

Quality of Life Clinical Trial

— HQOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01587976
• Other study ID #: 2011/570
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2012
• Last updated: March 27, 2015
• Start date: June 2011
• Est. completion date: December 2015

Study information

• Verified date: September 2013
• Source: Haukeland University Hospital
• Contact: Jon-Helge Angelsen, MD
• Phone: +4797520572
• Email: jhangelsen[@]gmail.com
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metastasis
• Neoplasm Metastasis
• Quality of Life

Locations

Country	Name	City	State
Norway	Departement of acute and digestive surgery, surgical clinic, Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No