COrSIcA: Patient Interviews
Research type
Research Study
Full title
Core Outcome measures in Squamous Intra-epithelial precursor lesions of the Anus (COrSIcA): Patient interviews
IRAS ID
321687
Contact name
David Finch
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
NHS002068, COrSIcA: Patient Interviews
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
Anal cancer can be prevented through detection and treatment of a recognised precancerous lesion, known as anal intra-epithelial neoplasia (AIN), specifically the anal high-grade squamous intra-epithelial lesion (aHSIL) subtype.
There are multiple treatments for aHSIL. These treatments have a variety of consequences for patients, including potential for quality-of-life (QOL) impact.
The evidence for aHSIL treatments is of poor quality, such that the optimal approach cannot be defined. Existing trials in aHSIL 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 patients, e.g., QOL.
We are developing a ‘core outcome set’ (COS) for trials in aHSIL. This is a list of outcomes (treatment effects) that future trials in aHSIL should measure and report on. COS include outcomes that are important to all involved with a particular condition (patients, doctors, trialists). Utilisation of the COS in future trials will ensure that the outcomes reported are meaningful to those affected, and comparable to determine the optimal approach.
To make sure the COS is relevant to patients, we will interview 20-30 participants whom are currently being treated or have previously been treated for aHSIL to explore their views and experiences of living with and having treatment for aHSIL. Interviews will last approximately 60 minutes and be undertaken at a location of the participants choice, options include; their own home, a clinic or meeting room at a local hospital/research facility, over the telephone or via an online conferencing platform such as Zoom.
By analysing the interviews, we will be able to determine the outcomes that are most important to patients. We anticipate the study to last approximately 1 year from conducting the first interview to completion of interview analysis.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
23/YH/0115
Date of REC Opinion
30 May 2023
REC opinion
Favourable Opinion