Core Outcome Set for Prevention of Oral Mucositis in Cancer Patients
Research type
Research Study
Full title
Core Outcome Set for Prevention of Oral Mucositis in Cancer Patients
IRAS ID
220077
Contact name
Philip Riley
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Oral mucositis is a common side-effect of cancer treatment with potentially serious consequences. There is a large volume of research on the prevention of oral mucositis, with very little evidence of beneficial preventive treatments. Outcome measures are the endpoint of research and “clinical trials are only as credible as their endpoints”. It is unethical to waste limited healthcare resources by assessing outcomes that are not considered important by patients or clinicians. The purpose of this research is to develop a core outcome set to be used in future clinical trials on the prevention of oral mucositis in patients of 16 years of age (young adults) and older receiving treatment for any type of cancer.
The research will involve using focus groups on The University of Manchester premises, involving people who have experienced oral mucositis during cancer treatment, to find out what were their major concerns. Participants will be free to end their participation at any time. The result will be an anonymised list of patient-important outcomes to feed into an international three-round Delphi process. The Delphi process will involve a range of stakeholders, including patients, carers, clinicians, nurses, and guideline developers. The purpose of the Delphi process will be to achieve consensus on a list of the most important outcomes. The demands on participants will be minimal (i.e. the participants will receive a list of outcomes, obtained from both the focus groups and a review of the literature, and will be asked to rate their importance on a 1 to 9 scale of increasing importance, adding any outcomes they feel are missing). All participants will be anonymised at all stages and may end their participation at any time. The research will take up to 6 months to complete.
REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/0464
Date of REC Opinion
9 Mar 2017
REC opinion
Favourable Opinion