MetastasisHQOLNCT01587976
Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases
An observational study of Metastasis and Quality of Life, run by Haukeland University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastasis, Quality of Life
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with resectable colorectal liver metastases treated at Haukeland and Stavanger University hospital, Norway.
Who may be able to join
- 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.
Who cannot join
- Drop out of questionnaire after surgery
- Patients found to be irresectable during the operation or where macroscopic tumor tissue are left behind.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Departement of acute and digestive surgery, surgical clinic, Haukeland University Hospital
Bergen, Bergen, N-5020
Arild Horn, MD, PhD, +4755972797, arild.horn@helse-bergen.no
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastasis, Quality of Life
- Keywords
- Health related quality of life, Colorectal liver metastasis, surveillance
- Medical subject headings
- Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after surgery
Secondary outcomes (1)
Identifying possible clinical parameters influencing the HQoL after liver resection.
Examples of parameters: complications, extent of surgery, chemotherapy.
Measured: Up to one year after surgery, maybe longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasisStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF
- Responsible party
- Sponsor
- Investigators
- August Bakke, Professor, Study director, Director, Surgical clinic, Haukeland University Hospital, Helse-Bergen HF, N-5020 Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587976
- Sponsor's protocol ID
- 2011/570
- Acronym
- HQOL
- Status last verified
- Sep 2013
- First submitted
- 27 Feb 2012
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT01587976
- Acronym / sponsor ID
- HQOL / 2011/570
- Conditions
- Metastasis, Quality of Life
- Keywords
- Health related quality of life, Colorectal liver metastasis, surveillance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF
- Study start
- Jun 2011
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with resectable colorectal liver metastases treated at Haukeland and Stavanger University hospital, Norway.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Drop out of questionnaire after surgery
- Patients found to be irresectable during the operation or where macroscopic tumor tissue are left behind.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health related quality of life after liver resection in combination with chemotherapy
Time frame: 12 months after surgery
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.
1 secondary outcome
Identifying possible clinical parameters influencing the HQoL after liver resection.
Time frame: Up to one year after surgery, maybe longer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
August Bakke, Professor study director
Director, Surgical clinic, Haukeland University Hospital, Helse-Bergen HF, N-5020 Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastasis and Quality of Life, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jon-Helge Angelsen, MD (+4797520572, jhangelsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life after liver resection in combination with chemotherapy (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.