A study developing a set of questions to help doctors identify problems after pelvic radiotherapy (DESIGNER)

Cancer type:

Bladder cancer
Bowel (colorectal) cancer
Cervical cancer
Ovarian cancer
Prostate cancer

Status:

Results

Phase:

Other

This study developed questions that helped doctors to identify people who had tummy or bowel problems following radiotherapy treatment for cancer. 

More about this trial

Radiotherapy to the area between the hips (the pelvis Open a glossary item) can cause long term side effects. For example, diarrhoea or pain. These symptoms can cause significant problems with socialising, work or travel. Despite being very common, sometimes these symptoms aren’t picked up.  

In this study, researchers developed a brief set of questions to help doctors identify the problems. The aim was it would help doctors to refer people to a specialist to control the symptoms that might cause these problems. This is called a screening tool.

The study team asked people who had problems after radiotherapy to fill out the screening tool they developed. They then asked them about any possible problems they could see with using the tool. 
Their answers helped the researchers to finalise the tool ready for doctors to use.
 

Summary of results

The team developed a screening tool called ALERT-B that doctors could use to identify people who might have problems after pelvic radiotherapy. 

About this study
There were 4 parts in the DESIGNER study. 

In part 1, the researchers developed the ALERT-B screening tool. They searched journals looking for articles about questionnaires already used to identify people with these problems. A panel of 8 people reviewed these questionnaires. The people were:

  • 2 cancer specialist doctors who treat cancers that need pelvic radiotherapy
  • 2 specialist doctors who treat diseases of the digestive system Open a glossary item and have experience of treating long term problems pelvic radiotherapy can cause
  • 3 staff members who are involved with research
  • 1 patient representative

In part 2, the team wanted to find out:

  • how easy ALERT-B was to use
  • if it was acceptable for patients 

A total of 12 people took part (6 women and 6 men). Between October 2013 and January 2014, the team interviewed these people. 

Each person completed the ALERT-B questionnaire. They were then asked about how easy it was to understand the instructions and the questions. 

In part 3, a panel of 9 people used what was reported in part 2 to improve the questions in the ALERT-B screening tool. The people were:

  • 3 cancer specialist doctors
  • 3 specialist doctors who treat diseases of the digestive system
  • 2 staff members who were involved with research
  • 1 patient representative

In the part 4, the ALERT-B screening tool was tested in a clinical trial Open a glossary item.  

Results
3 questions made up the final ALERT-B tool. The researchers found the questionnaire was:

  • easy to understand
  • easy and quick to fill in 

The questions covered the following:

  • bleeding from the back passage
  • inability to control bowel movements causing leaking (incontinence)
  • going to the toilet during the night
  • the impact on quality of life Open a glossary item including mood, relationships and socialising

Conclusion
The study team concluded that ALERT-B is a useful screening tool. Doctors can use it to improve the supportive care after radiotherapy to the area between the hips (pelvis). It can prompt the doctor when to refer the patient to another doctor who specialises in problems with the digestive system. 

A clinical trial called EAGLE has tested and confirmed that ALERT-B is a useful screening tool. 

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 Green

Supported by

Cardiff University
National Institute for Health Research Cancer Research Network (NCRN)
Tenovus

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 10987

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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