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

December 30, 2022 updated by: Liverpool University Hospitals NHS Foundation Trust

Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients (PCI-QoL)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

416

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L9 7AL
        • Aintree University Hospital NHS Foundation Trust
      • Liverpool, Merseyside, United Kingdom, L35 5DR
        • St Helens & Knowsley Teaching Hospitals NHS Trust
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS1 3EX
        • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PCI Group
Participants who are patients of consultants randomized to this group will use the PCI during clinics.
Other: Patient Concerns Inventory
Other Names:
  • PCI Group
Other: Non PCI Group
Participants who are patients of consultants randomized to this group will not use the PCI during clinics.
Other: No Patient Concerns Inventory
Other Names:
  • Non PCI Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UWQOL v4 QoL
Time Frame: Post-Treatment 1 Year Review Clinic
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Collaborators

The Leeds Teaching Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Bangor University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/NW/0465

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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