Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients

Not Applicable

Completed

• Conditions: Cancer of Head and Neck
• Interventions: Other: No Patient Concerns Inventory; Other: Patient Concerns Inventory

• Registration Number: NCT03086629
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

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).

Study Timeline

• Study First Submitted: 2016-08-01
• Study Start: 2017-01
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-22
• Status Verified: 2018-07
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Last Update Submitted: 2022-12-30
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non PCI Group	No Patient Concerns Inventory	Participants who are patients of consultants randomized to this group will not use the PCI during clinics.
PCI Group	Patient Concerns Inventory	Participants who are patients of consultants randomized to this group will use the PCI during clinics.

Primary Outcome Measures

Name	Time	Method
UWQOL v4 QoL	Post-Treatment 1 Year Review Clinic	The percentage of participants with less than good overall quality of life at the final one-year clinic.

Secondary Outcome Measures

Name	Time	Method
UWQOL v4 Questionnaire	Post-Treatment 1 Year Review Clinic	Mean social-emotional subscale score
CSRI	6 Month and 12 Month Post-Treatment Review Clinics	Key health economics questionnaire
Distress Thermometer VAS	Post-Treatment 1 Year Review Clinic	Score ≥4
QALY-EQ-5D-5L	Post-Treatment 1 Year Review Clinic	Key health economics questionnaire

Trial Locations

Locations (3)

St Helens & Knowsley Teaching Hospitals NHS Trust; 🇬🇧 Liverpool, Merseyside, United Kingdom

Aintree University Hospital NHS Foundation Trust; 🇬🇧 Liverpool, Merseyside, United Kingdom

Leeds Teaching Hospitals Nhs Trust; 🇬🇧 Leeds, Yorkshire, United Kingdom