title: Development of a head and neck companion module for the quality of life-radiation therapy instrument (QOL-RTI)
abstract: OBJECTIVE
  A review of available head and neck quality of life (QOL) instruments reveals them to inadequately address important radiation related side effects, or to be too cumbersome for routine use. The purpose of this study was to develop a head and neck disease specific module as a companion to the previously developed quality of life - radiation therapy instrument (QOL-RTI). The goal was to create a more complete, yet concise, head and neck site-specific module geared toward patients receiving radiation therapy for head and neck cancer.
  
  
  METHODS
  This exploratory study included 34 consecutive patients undergoing definitive radiotherapy over a 6-7 week course (60-79.8 Gy). We developed and administered a 14-item questionnaire to all eligible patients treated with radiotherapy for head and neck cancer who were not already registered in another research study assessing quality of life (e.g., RTOG). During the treatment period, the QOL-RTI general tool and the head and neck (H&N) module were administered as follows: at baseline, at week four (for test-retest), and at the end of the treatment period. For validation purposes the QOL-RTI/H&N was compared to the functional assessment cancer tool head and neck (FACT-H&N) questionnaire. The FACT-H&N was administered one time at week 4, on the same day as the QOL-RTI/H&N. This report includes the treatment phase of the study (during the course of radiation).
  
  
  RESULTS
  Mean age was 62 years (range 40-75). Internal consistency of the module was satisfactory (Chronbach's alpha = 0.85). Test-retest yielded a correlation coefficient of 0.90 (p < 0.001). Concurrent validity, established by comparing the module to the FACT/H&N , yielded a correlation coefficient of 0.85. Significant changes in quality of life scores during a course of radiation was noted for both general quality of life tool and the site specific module. For the head and neck module, the difference in the mean baseline (7.17) and end of treatment scores (4.20) was 2.94, or 42% change (p < 0.0001). A smaller, yet still significant, difference in scores was seen in the general QOL tool (22 % change, p = 0.001). Item analysis of the module revealed statistically significant (p < 0.05) worsening in quality of life scores in the following areas: pain in throat, swallowing difficulty (meat/bread and liquids), changes in mucous and saliva, changes in taste, difficulty chewing, trouble with coughing, and speech difficulties. Items that were not significant were pain in the mouth, and appearance.
  
  
  CONCLUSIONS
  These initial results suggest that the H&N companion module to the QOL-RTI is a valid and reliable tool that is responsive to changes in QOL during a course of H&N radiation therapy. This tool differs from existing H&N tools by including specific assessments of mucous, saliva, taste, cough, and local pain in a concise format. Significant changes in QOL scores were noted in all of these items. Evaluation of the tool in the post-treatment period (follow-up) is ongoing.
authors.affiliation: Division of Radiation Oncology, and the Biostatistics Core, University of South Florida, James A. Haley VA Medical Center, Tampa, USA. trotti@moffitt.usf.edu
authors.forename: A
authors.initials: A
authors.lastname: Trotti
authors.forename: D J
authors.initials: DJ
authors.lastname: Johnson
authors.forename: C
authors.initials: C
authors.lastname: Gwede
authors.forename: L
authors.initials: L
authors.lastname: Casey
authors.forename: B
authors.initials: B
authors.lastname: Sauder
authors.forename: A
authors.initials: A
authors.lastname: Cantor
authors.forename: J
authors.initials: J
authors.lastname: Pearlman
mesh_terms: D000328:Adult; D000368:Aged; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires