Clinical trial NCT03086629: Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients
Official title: Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients (PCI-QoL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
name: National Institute for Health Research, United Kingdom
name: Bangor University
First posted: 2017-03-22
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: 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 the percentage of participants with less than good overall quality of life at the final one-year clinic as measured by the single UWQOLv4 question.

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-5L; CSRI).

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 recruited from 14 MFU and ENT consultants 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).

Eligibility criteria: Inclusion Criteria:

* Patients with HNC
* To be treated curatively (all sites, stage of disease, treatments).

Exclusion Criteria:

* Patients treated with palliative intent
* Patients with a recurrence.
* Patients with a history of cognitive impairment, psychoses or dementia

Primary outcomes:
measure: UWQOL v4 QoL
timeFrame: Post-Treatment 1 Year Review Clinic
Secondary outcomes:
measure: UWQOL v4 Questionnaire
timeFrame: Post-Treatment 1 Year Review Clinic
measure: Distress Thermometer VAS
timeFrame: Post-Treatment 1 Year Review Clinic
measure: QALY-EQ-5D-5L
timeFrame: Post-Treatment 1 Year Review Clinic
measure: CSRI
timeFrame: 6 Month and 12 Month Post-Treatment Review Clinics
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: St Helens & Knowsley Teaching Hospitals NHS Trust
state: Merseyside
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital NHS Foundation Trust
state: Merseyside
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals Nhs Trust
state: Yorkshire
Study officials:
References:
citation: 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.
citation: Ezeofor 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.
citation: Rogers 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.