A study testing a quality of life questionnaire for cancer of the gallbladder and bile duct (QoL BIL)

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Cancer type:

Bile duct cancer
Biliary tree cancers
Gallbladder cancer

Status:

Results

Phase:

Phase 4

This study looked at a quality of life questionnaire for people with gallbladder cancer and cancer of the bile duct.

More about this trial

It is important to find out how the symptoms of cancer and the side effects of treatment affect people’s quality of life Open a glossary item.  To find this out, doctors ask people to fill in quality of life questionnaires. 

The only questionnaire that people with gallbladder cancer and cancer of the bile duct could fill in was a general one for cancer.  It didn’t draw attention to any particular problems that people with gallbladder cancer and cancer of the bile duct had.  

The researchers developed a questionnaire (QLQ-BIL21) that looked particularly at the quality of life for people with gallbladder cancer and cancer of the bile duct. 

They wanted to find out if it gave a better measure of quality of life for these people when used alongside the general questionnaire.

Summary of results

The study team found the QLQ-BIL21 questionnaire can be used to measure the quality of life for people with these cancers. 
 
This study was open for people to join between September 2011 and June 2014.
 
The results were published in 2016.
 
About this study
This was an international phase 4 study. 
 
Worldwide 263 people joined the study:
  • 172 people had cancer of the bile duct
  • 91 people had gallbladder cancer   
Everyone filled in the QLQ-BIL21 questionnaire and the general quality of life questionnaire (QLQ-C30) before treatment and then 2 months later. 
 
Results
 
Completing the questionnaires 
Of the 263 people, 256 completed the QLQ-BIL21 questionnaire before starting treatment. 
 
75 people didn’t complete the questionnaire 2 months later. Of these:
  • 48 people had died
  • 11 people were lost to follow up
  • 13 people weren’t well enough
  • 3 people for other reasons
When the team looked at where the questionnaire was filled in they found that:
  • 168 people (66%) did so at the hospital outpatient clinic
  • 28 people (10.7%) did so at home
  • 20 people (7.8%) did so as a patient in hospital
  • 39 people (15.2%) did so elsewhere
They also looked at the time it took to complete the QLQ-BI21 and the QLQ-C30 questionnaires. They found that most of the people (89.1%) completed both in less than 20 minutes. 
  • 98 people (38.3%) did so in less than 10 minutes
  • 88 people (34.4%) did so between 11 and 15 minutes
  • 42 people (16.4%) did so between 16 and 20 minutes
  • 23 people (9.0%) did so between 21 and 30 minutes
  • 4 people (1.6%) took more than 30 minutes
41 people (61%) found 1 or more questions difficult to answer. 
 
115 people (45%) found at least 1 question not applicable. 
 
How reliable and dependable is QLQ-BIL21 
The team found that the questions in QLQ-BIL21 measured what they were intended to measure. And the QLQ-BIL21 questionnaire produced reliable and consistent results.
 
The questionnaire was able to measure significant differences to the quality of life from before treatment and 2 months later. 
 
The team found there was no difference between using the QLQ-BIL21 questionnaire for people with gallbladder cancer and cancer of the bile duct. 
 
Conclusion
The study team concluded that QLQ-BIL21 is an accurate and reliable quality of life questionnaire for people with gallbladder cancer and cancer of the bile duct. They recommend it should be used in clinical trials and during treatment to provide an accurate guide for therapy and future research. 
 
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr John K Ramage

Supported by

Hampshire Hospitals NHS Foundation Trust
European Organisation for Research and Treatment of Cancer (EORTC)
NIHR Clinical Research Network: Cancer

 

 

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Last review date

CRUK internal database number:

8736

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

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“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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