ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03086629
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : July 3, 2018
Sponsor:
Collaborators:
The Leeds Teaching Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Bangor University
Information provided by (Responsible Party):
Aintree University Hospitals NHS Foundation Trust

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).


Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Other: Patient Concerns Inventory Other: No Patient Concerns Inventory Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients (PCI-QoL)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
PCI Group
Participants who are patients of consultants randomized to this group will use the PCI during clinics.
Other: Patient Concerns Inventory
Other Name: PCI Group

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 Name: Non PCI Group




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086629


Contacts
Contact: Simon N Rogers 0151 5295287 simonn.rogers@aintree.nhs.uk

Locations
United Kingdom
St Helens & Knowsley Teaching Hospitals NHS Trust Recruiting
Liverpool, Merseyside, United Kingdom, L35 5DR
Aintree University Hospital NHS Foundation Trust Recruiting
Liverpool, Merseyside, United Kingdom, L9 7AL
Contact: Paula Harlow    0151 529 ext 5924    paula.harlow@aintree.nhs.uk   
Principal Investigator: Simon N Rogers         
Leeds Teaching Hospitals Nhs Trust Recruiting
Leeds, Yorkshire, United Kingdom, LS1 3EX
Contact: Jennifer Broads    0113 34 36197    J.A.Boards@leeds.ac.uk   
Principal Investigator: Anastasios Kanatas         
Sponsors and Collaborators
Aintree University Hospitals NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Bangor University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03086629     History of Changes
Other Study ID Numbers: 16/NW/0465
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms