"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study to develop standards for anal cancer trials (CORMAC study)
This study was for people who had treatment or were having treatment for anal cancer.
It was 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
Studies for new treatments should tell doctors how well a treatment works. They should also tell them how side effects impact on things such as 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 is trying to tackle this problem.
The CORMAC study was in 3 parts.
In the first part researchers interviewed people with anal cancer. They asked about their thoughts and feelings of their experience of anal cancer. They also asked what was important to them in terms of their treatment and side effects. These are called treatment outcomes.
Using these responses, the researchers created a core outcome set. This is a 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 asked a number of people with anal cancer to fill in surveys. They were given a list of outcomes and were asked to rate how important the outcomes were. A group of health professionals also took part.
In the third part, people who had taken part in the interviews and surveys (both people who had anal cancer and health professionals) were brought together to discuss the results face to face and agree a final ‘core’ set of outcomes.
The aim of this was to reach some agreement on these core outcomes and find out which outcomes to use in future trials.
Summary of results
- 73 were patients
- 109 were healthcare professionals
- 55 people were patients
- 94 were healthcare professionals
- 13 patients
- 23 healthcare professionals
Final core outcome list (CORMAC core outcome set)
- Treatment response
- Local failure
- Regional failure
- Distance failure
- Disease progression
- Salvage surgery
- Overall survival
- Cancer-specific survival
- Disease-free survival
- Metastatic-free survival
- Progression-free survival
- Anal incontinence
- Faecal urgency
- Pelvic fistula
- Colostomy or ileostomy
- Skin loss
- Physical function
- Sexual function
- Health-related quality of life
How to join a clinical trial
NIHR Clinical Research Network: Cancer
University of Manchester