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

Cancer of Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086629
• Other study ID #: 16/NW/0465
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2018
• Source: Liverpool University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Intervention

Other:
• Patient Concerns Inventory

• No Patient Concerns Inventory

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals Nhs Trust	Leeds	Yorkshire
United Kingdom	Aintree University Hospital NHS Foundation Trust	Liverpool	Merseyside
United Kingdom	St Helens & Knowsley Teaching Hospitals NHS Trust	Liverpool	Merseyside

Sponsors (4)

Lead Sponsor	Collaborator
Liverpool University Hospitals NHS Foundation Trust	Bangor University, National Institute for Health Research, United Kingdom, The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	UWQOL v4 Questionnaire	Mean social-emotional subscale score	Post-Treatment 1 Year Review Clinic
Secondary	Distress Thermometer VAS	Score =4	Post-Treatment 1 Year Review Clinic
Secondary	QALY-EQ-5D-5L	Key health economics questionnaire	Post-Treatment 1 Year Review Clinic
Secondary	CSRI	Key health economics questionnaire	6 Month and 12 Month Post-Treatment Review Clinics