Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients
Condition: Cancer of Head and Neck
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

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).
    

Intervention name(s): Patient Concerns Inventory; No Patient Concerns Inventory
Intervention type(s): Other; Other
Other intervention name(s): PCI Group; Non PCI Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care