Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients
1 other identifier
interventional
416
1 country
3
Brief 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. The 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. The primary outcome is an improvement in QOL. Secondary outcomes are: social-emotional scale, distress thermometer and health economics. This will be a pragmatic cluster randomised control trial with consultants randomised to either 'using or 'not using' the PCI at clinic. It will involve two centres. 416 patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome. Intervention; 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJanuary 4, 2023
July 1, 2018
3.5 years
August 1, 2016
December 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
UWQOL v4 QoL
The percentage of participants with less than good overall quality of life at the final one-year clinic.
Post-Treatment 1 Year Review Clinic
Secondary Outcomes (4)
UWQOL v4 Questionnaire
Post-Treatment 1 Year Review Clinic
Distress Thermometer VAS
Post-Treatment 1 Year Review Clinic
QALY-EQ-5D-5L
Post-Treatment 1 Year Review Clinic
CSRI
6 Month and 12 Month Post-Treatment Review Clinics
Study Arms (2)
PCI Group
OTHERParticipants who are patients of consultants randomized to this group will use the PCI during clinics.
Non PCI Group
OTHERParticipants who are patients of consultants randomized to this group will not use the PCI during clinics.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with HNC
- To be treated curatively (all sites, stage of disease, treatments).
You may not qualify if:
- Patients treated with palliative intent
- Patients with a recurrence.
- Patients with a history of cognitive impairment, psychoses or dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liverpool University Hospitals NHS Foundation Trustlead
- The Leeds Teaching Hospitals NHS Trustcollaborator
- National Institute for Health Research, United Kingdomcollaborator
- Bangor Universitycollaborator
Study Sites (3)
St Helens & Knowsley Teaching Hospitals NHS Trust
Liverpool, Merseyside, L35 5DR, United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, Merseyside, L9 7AL, United Kingdom
Leeds Teaching Hospitals Nhs Trust
Leeds, Yorkshire, LS1 3EX, United Kingdom
Related Publications (3)
Kanatas A, Lowe D, Rogers SN. Health-related quality of life at 3 months following head and neck cancer treatment is a key predictor of longer-term outcome and of benefit from using the patient concerns inventory. Cancer Med. 2022 Apr;11(8):1879-1890. doi: 10.1002/cam4.4558. Epub 2022 Feb 17.
PMID: 35178880DERIVEDEzeofor V', Spencer LH, Rogers SN, Kanatas A, Lowe D, Semple CJ, Hanna JR, Yeo ST, Edwards RT. An Economic Evaluation Supported by Qualitative Data About the Patient Concerns Inventory (PCI) versus Standard Treatment Pathway in the Management of Patients with Head and Neck Cancer. Pharmacoecon Open. 2022 May;6(3):389-403. doi: 10.1007/s41669-021-00320-4. Epub 2022 Jan 31.
PMID: 35099783DERIVEDRogers SN, Lowe D, Lowies C, Yeo ST, Allmark C, Mcavery D, Humphris GM, Flavel R, Semple C, Thomas SJ, Kanatas A. Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: a cluster preference randomized controlled trial. BMC Cancer. 2018 Apr 18;18(1):444. doi: 10.1186/s12885-018-4355-0.
PMID: 29669529DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2016
First Posted
March 22, 2017
Study Start
January 1, 2017
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
January 4, 2023
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share