A study to develop standards for anal cancer trials (CORMAC study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Anal cancer

Status:

Closed

Phase:

Other

This study is for people who have had treatment or are having treatment for anal cancer.

It is part of a project looking at improving anal cancer studies.

More about this trial

Treatment for anal cancer can cause short and long term side effects. These side effects can affect your quality of life Open a glossary item.

Studies for new treatments should tell doctors how well a treatment works. They should also tell them how side effects affect your quality life. In the past, trials in anal cancer used different ways to measure the effects of treatment. This makes it difficult to compare the results and reach any conclusions.

This study has 2 parts. The first part is now complete. The researchers interviewed people with anal cancer. They asked about their thoughts and feelings of their experience of anal cancer. They also asked what treatment outcomes were important to them.

Using these responses, the researchers created a core outcome set. This is set of measures (standards) that hopefully all trials in anal cancer will use in the future. This should mean that there is greater consistency over the way treatment outcomes are measured and reported.

In the second part, the researchers will ask a larger number of people with anal cancer to fill in questionnaires. You are asked to rate how important the outcomes are. A group of health professionals will also take part.

The aim of this trial is to reach some agreement on these core outcomes and find out which should be used in future trials. 

You may not directly benefit from taking part in the study. By taking part, you can help in writing the standards for anal cancer studies. This will benefit people with anal cancer in future. 

Who can enter

The following bullet points list the entry conditions for this study. If you are unsure about any of these speak with your doctor or the study team. They will be able to advise you. 

You have 1 of the following types of anal cancer:

  • squamous cell, also called an epidermoid type
  • basaloid
  • baso-squamous
  • cloacogenic
  • transitional cell tumours

Diagram showing the anatomy of the anus

And you must also have had or are having external radiotherapy with chemotherapy (chemoradiation) with the aim of curing your cancer.

Trial design

This is a UK quality of life study. There are 2 parts, the first part is complete.

You might be asked to take part:

  • by your doctor or nurse at your follow up appointment
  • by letter in the post
  • via patient groups, for example through social media

Or you might see a poster asking for volunteers in your hospital.

You are asked to fill in a questionnaire on at least 2 separate occasions. You can do this at home either:

  • online on your computer or tablet  
  • filling in a paper questionnaire and sending it back by post

In the questionnaire, you are asked to rate the importance of a list of outcomes. You rate them on a scale of 1 (not important) to 9 (extremely important).

It will take about an hour to fill in the questionnaire. You don’t have to do this in one sitting. You can save your answers and come back to it later, if you are filling in the form online.

When everyone has completed the questionnaire, the team will contact you and ask you to fill in the same questionnaire again. This time you are shown how other people have rated the outcomes. You have the option to leave your rating the same, or change your rating.

The researchers will then look at the answers of the health professionals and those with anal cancer. They will identify those outcomes:

  • most important to people
  • agreed by most of those taking part

You might be asked to fill the questionnaire a third time if the researchers think this is necessary. 

Hospital visits

You do not have any hospital visits as a result of taking part in this study.

Side effects

Rating these outcomes will make you think about your diagnosis and treatment. This might be upsetting. 

The study team can talk to you about where to get support if you need it. 

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

Rebecca Fish

Supported by

NIHR Clinical Research Network:  Cancer
University of Manchester

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13713

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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