Clinical trial · Interventional
Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients
Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients (PCI-QoL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Patient Concerns Inventory | Other | — | UNRESOLVED |
| Patient Concerns Inventory | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- PCI Group
- description
- Participants who are patients of consultants randomized to this group will use the PCI during clinics.
- interventionNames
- Other: Patient Concerns Inventory
- type
- OTHER
- label
- Non PCI Group
- description
- Participants who are patients of consultants randomized to this group will not use the PCI during clinics.
- interventionNames
- Other: No Patient Concerns Inventory
Primary outcomes (1)
- measure
- UWQOL v4 QoL
- timeFrame
- Post-Treatment 1 Year Review Clinic
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDKanatas 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. PMID 35178880
- DERIVEDEzeofor 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. PMID 35099783
- DERIVEDRogers 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. PMID 29669529