Impact of treatment options for benign thyroid nodules on QoL
Research type
Research Study
Full title
Impact of treatment options on health related quality of life (QoL) in patients with benign thyroid nodules: a feasibility and acceptability study.
IRAS ID
238978
Contact name
Farhan Ahmad
Contact email
Sponsor organisation
Royal Berkshire NHS Foundation Trust
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
Benign thyroid nodules are common non-cancerous neck lumps. Occasionally large nodules cause local symptoms, such as pressure, pain and difficulty breathing. This leads patients to seek treatment. Standard treatment is surgery to remove the nodule and involves a general anaesthetic and potentially a large neck scar. At the Royal Berkshire Hospital over 120 operations are performed annually for this condition. Another option is a conservative approach where active treatment is delayed until necessary.
A new alternative approach is minimally invasive ultrasound guided radiofrequency ablation (RFA). RFA has recently been approved by NICE as a treatment for enlarged thyroids. It is safe and effective at nodule shrinkage. It has a number of perceived benefits over surgery as it is minimally invasive and performed under local anaesthetic. It avoids a neck scar, in-patient admission and the need for long-term thyroid replacement tablets. Health related quality of life (HRQoL) is an important consideration when patients decide on treatment. There is currently very little information on the impact of surgery, RFA and a conservative approach on HRQoL.
Our aim is to explore whether it is possible to recruit to a trial investigating differences in HRQoL for patients undergoing these management options and whether a larger multi-centre study of this type would be feasible.
Over a 6-month period we aim to recruit a maximum of 10 patients with enlarged thyroid nodules to each research group (total maximum 30 patients but number dependent on feasibility of recruitment). All will complete a questionnaire determining the HRQoL impact of available treatment options. Data will be collected at baseline (once treatment option confirmed), then 3 and 6 months post-procedure. Of these patients; 3 from each group will also be interviewed to explore their experiences further. Funding has been awarded through the British Society of Interventional Radiology.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
19/LO/0876
Date of REC Opinion
30 Jul 2019
REC opinion
Further Information Favourable Opinion