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

NCT ID: NCT03086629

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-06-30

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).

Conditions

Cancer of Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PCI Group

Participants who are patients of consultants randomized to this group will use the PCI during clinics.

Group Type: OTHER

Patient Concerns Inventory

Intervention Type: OTHER

Non PCI Group

Participants who are patients of consultants randomized to this group will not use the PCI during clinics.

Group Type: OTHER

No Patient Concerns Inventory

Intervention Type: OTHER

Interventions

Patient Concerns Inventory

Intervention Type: OTHER

No Patient Concerns Inventory

Intervention Type: OTHER

Other Intervention Names

PCI Group; Non PCI Group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Bangor University

OTHER

Sponsor Role: collaborator

Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35178880 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35099783 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29669529 (View on PubMed)

Other Identifiers

16/NW/0465

Identifier Type: -

Identifier Source: org_study_id