TY - JOUR

T1 - Study protocol- Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: a cluster preference randomised controlled trial

AU - Rogers, SN

AU - Lowe, D

AU - Lowie, C

AU - Yeo, ST

AU - Allmark, C

AU - Mcavery, D

AU - Humphris, GM

AU - Flavel, R

AU - Semple, C

AU - Thomas, SJ

AU - Kanatas, A

N1 - This trial is funded by the RfPB on behalf of the NIHR (PB-PG-0215-36047)

PY - 2018/4/18

Y1 - 2018/4/18

N2 - Background: The consequences of treatment for Head and Neck cancer (HNC) patients has profound detrimental impacts such as impaired QOL, emotional distress, delayed recovery and frequent use of healthcare. The aim of this trial is to determine if the routine use of the Patients Concerns Inventory (PCI) package in review clinics during the first year following treatment can improve overall quality of life, reduce the social-emotional impact of cancer and reduce levels of distress. Furthermore, we aim to describe the economic costs and benefits of using the PCI.Methods: This will be a cluster preference randomised control trial with consultants either ‘using’ or ‘not using’ the PCI package at clinic. It will involve two centres Leeds and Liverpool. 416 eligible patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome. The primary outcome is the percentage of participants with less than good overall quality of life at the final one-year clinic as measured by the University of Washington QOL questionnaire version 4 (UWQOLv4). Secondary outcomes at one-year are the mean social-emotional subscale (UWQOLv4) score, Distress Thermometer (DT) score≥4, and key health economic measures (QALY-EQ-5D-5 L; CSRI).Discussion: This trial will provide knowledge on the effectiveness of a consultation intervention package based around the PCI used at routine follow-up clinics following treatment of head and neck cancer with curative intent. If this intervention is (cost) effective for patients, the next step will be to promote wider use of this approach as standard care in clinical practice.Trial registration: 32,382. Clinical Trials Identifier, NCT03086629.

AB - Background: The consequences of treatment for Head and Neck cancer (HNC) patients has profound detrimental impacts such as impaired QOL, emotional distress, delayed recovery and frequent use of healthcare. The aim of this trial is to determine if the routine use of the Patients Concerns Inventory (PCI) package in review clinics during the first year following treatment can improve overall quality of life, reduce the social-emotional impact of cancer and reduce levels of distress. Furthermore, we aim to describe the economic costs and benefits of using the PCI.Methods: This will be a cluster preference randomised control trial with consultants either ‘using’ or ‘not using’ the PCI package at clinic. It will involve two centres Leeds and Liverpool. 416 eligible patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome. The primary outcome is the percentage of participants with less than good overall quality of life at the final one-year clinic as measured by the University of Washington QOL questionnaire version 4 (UWQOLv4). Secondary outcomes at one-year are the mean social-emotional subscale (UWQOLv4) score, Distress Thermometer (DT) score≥4, and key health economic measures (QALY-EQ-5D-5 L; CSRI).Discussion: This trial will provide knowledge on the effectiveness of a consultation intervention package based around the PCI used at routine follow-up clinics following treatment of head and neck cancer with curative intent. If this intervention is (cost) effective for patients, the next step will be to promote wider use of this approach as standard care in clinical practice.Trial registration: 32,382. Clinical Trials Identifier, NCT03086629.

KW - Head and Neck Cancer

KW - Quality of life

KW - Patient reported outcomes

KW - Intervention

KW - Patient concerns inventory

U2 - 10.1186/s12885-018-4355-0

DO - 10.1186/s12885-018-4355-0

M3 - Article

VL - 18

JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

M1 - 444

ER -