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Completed

NCT Number: NCT03086629

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

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).

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Key information

Conditions

Cancer of Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aintree University Hospital NHS Foundation Trust, Liverpool, Merseyside, United Kingdom

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Concerns Inventory

Other

Other names: PCI Group

No Patient Concerns Inventory

Other

Other names: Non PCI Group

Primary outcomes

  1. 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.

Secondary outcomes

  1. UWQOL v4 Questionnaire

    Time frame: Post-Treatment 1 Year Review Clinic

    Mean social-emotional subscale score

  2. Distress Thermometer VAS

    Time frame: Post-Treatment 1 Year Review Clinic

    Score ≥4

  3. QALY-EQ-5D-5L

    Time frame: Post-Treatment 1 Year Review Clinic

    Key health economics questionnaire

  4. CSRI

    Time frame: 6 Month and 12 Month Post-Treatment Review Clinics

    Key health economics questionnaire

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2017
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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