DEVELOPMENT OF A HEAD AND NECK COMPANION MODULE FOR THE QUALITY OF LIFE-RADIATION THERAPY INSTRUMENT (QOL-RTI)

Purpose/Objective: A review of available head and neck quality of life (QOL) instruments reveals them to inadequately address important radi ation related side effects, or to be too cumbersome for routine use. T he purpose of this study was to develop a head and neck disease specif ic 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 towa rd patients receiving radiation therapy for head and neck cancer. Meth ods and Materials: This exploratory study included 34 consecutive pati ents undergoing definitive radiotherapy over a 6-7 week course (60-79. 8 Gy). We developed and administered a 14-item questionnaire to all el igible patients treated with radiotherapy for head and neck cancer who were not already registered in another research study assessing quali ty of life (e.g., RTOG). During the treatment period, the QOL-RTI gene ral tool and the head and neck (H&N) module were administered as follo ws: 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 compare d to the functional assessment cancer tool head and neck (FACT-H&N) qu estionnaire. 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 6 2 years (range 40 -75). Internal consistency of the module was satisfa ctory (Chronbach's alpha = 0.85). Test-retest yielded a correlation co efficient of 0.90 (p < 0.001). Concurrent validity, established by com paring the module to the FACT/H&N, yielded a correlation coefficient o f 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 s ite specific module. For the head and neck module, the difference in t he mean baseline (7.17) and end of treatment scores (4.20) was 2.94, o r 42% change (p < 0.0001). A smaller, yet still significant, differenc e 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 wer e pain in the mouth, and appearance. Conclusion: These initial results suggest that the H&N companion module to the QOL-RTI is a valid and r eliable 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 inc luding specific assessments of mucous, saliva, taste, cough, and local pain in a concise format. Significant changes in QOL scores were note d in all of these items. Evaluation of the tool in the post-treatment period (follow-up) is ongoing. (C) 1998 Elsevier Science Inc.