CORMAC: Core Outcome Research Measures in Anal Cancer
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
IRAS ID
183034
Contact name
Lynne Macrae
Contact email
Duration of Study in the UK
1 years, 11 months, 30 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 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.
We are developing 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 study is to determine the outcomes that are most relevant and important to individuals who have, or have had anal cancer. We will be interviewing 20-30 individuals to explore their perceptions, priorities and experiences of living with and having treatment for anal cancer. Through analysis of the interviews we will identify the outcomes that are most important to them. The outcome list generated will be combined with a list of outcomes identified through a systematic review of the published literature. The longlist of outcomes generated from the patient interviews and systematic review will form the starting point from which a final core set of outcomes will be derived using a series of questionnaire surveys (Delphi process) and consensus meetings.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0971
Date of REC Opinion
22 Dec 2015
REC opinion
Further Information Favourable Opinion