CORMAC: Core Outcome Research Measures in Anal Cancer phase 2
Research type
Research Study
Full title
CORMAC: Core Outcome Research Measures in Anal Cancer Development of a core outcome set for informed consent, clinical trials and treatment policy in patients with anal cancer. Phase 2: Delphi process & consensus meetings
IRAS ID
215791
Contact name
Rebecca Fish
Contact email
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
A high proportion of patients with anal cancer are considered cured after treatment. However, the treatment can cause short and long term side effects that reduce quality of life for survivors. Clinical trials of new treatments need to be able to measure how well a treatment works. It is also important that they measure how side effects impact on the quality of life of patients. Existing trials in anal cancer have used different ways of measuring the effects of treatment. This makes comparing the results of trials very difficult. Trials have also been poor at reporting how treatment affects quality of life.
The aim of the CORMAC project is to develop a ‘core outcome set’ for trials of treatment for anal cancer. This is a list of outcomes that all trials should measure and report. Having a core outcome set will make sure that the results from all future trials can be combined to get a better understanding of which treatments are best. It will also help to ensure that outcomes such as side effects and quality of life are included in research studies.
The aim of this phase of the study is to agree which outcomes should be included in the core outcome set by conducting a Delphi process and face to face consensus meetings involving patients, clinicans and trialists. The Delphi process involves 3 sequential rounds of questionnaires with feedback given between each round, and is a well described method for reaching consensus. The outcomes included in the Delphi questionnaires are derived from the results of the systematic review and patient interviews that were conducted for phase 1 of this project. The outcomes selected through the Delphi survey will be ratified for inclusion in a final core outcome set at a consensus meeting involving all stakeholder groups.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0392
Date of REC Opinion
2 Dec 2016
REC opinion
Favourable Opinion