Patient Concerns Inventory in head and neck cancer clinics
Research type
Research Study
Full title
Improving quality of life through the routine use of the Patient Concerns Inventory for head and neck cancer patients (PCI-QOL)
IRAS ID
189554
Contact name
Simon Rogers
Contact email
Sponsor organisation
Aintree University Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The Patient Concerns Inventory (PCI) for head and neck cancer (HNC) patients has been developed and used largely within the confines of a single clinic setting and has not been used routinely with patients in the first year following treatment. Research so far suggests it is popular with patients, they would like to continue to use it in clinic and it is feasible. Benefits of its routine repeated use is untested, notably its impact on improving QOL and in reducing emotional distress, especially within the first year after treatment when patients are more likely to benefit from repeated use of the PCI. \n\nThe overarching aim of the proposed research is to explore whether the routine use of the PCI in review clinics during the first year following head and neck cancer treatment can improve patients quality of life. \n\nThe primary outcome is an improvement in QOL. Secondary outcomes are: \nsocial-emotional scale, distress thermometer and health economics. \n\nThis will be a pragmatic cluster randomised control trial with consultants randomised to either ‘using or ‘not using’ the PCI at clinic. It will involve three sites. 416 patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome.\n\nInclusion Criteria: All patients with a first occurrence of HNC, treated curatively (all sites, stage of disease, treatments). To ensure participation of patients with little or no written or spoken English, we will provide translation services to help them complete questionnaires.\n\nIntervention; Patient completion of the PCI and its inclusion into the regular review clinic consultation is the ’intervention’ and is compared to standard out-patient follow-up. The pre-consultation questionnaires and PCI will be used from the first post-treatment clinic (i.e. baseline) onwards for one year. Completion of all pre-consultation questionnaires and the PCI is by computer (IPAD). \n\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0465
Date of REC Opinion
8 Jul 2016
REC opinion
Favourable Opinion