International Phase IV Field Study for the Reliability and Validity of the European Organisation for Research and Treatment of Cancer Thyroid Cancer Module EORTC QLQ-THY34.

Purpose: The aim of this study was to validate the new European Organisation for Research and Treatment of Cancer Quality of Life Thyroid Cancer Module (EORTC QLQ-THY34). Methods: We enrolled 437 thyroid cancer patients from 17 countries. One group (n = 303), undergoing treatment or best supportive care, completed the questionnaires at three time points (before therapy [t1], 6 weeks later [t2], and 6 months after t2 [t3]). A second group (survivors ≥2 years after diagnosis, n = 134) completed it at a random baseline time point and a second time 1 week later. We determined internal consistency (using Cronbach's alpha), the scale structure (with confirmatory factor analysis), and discriminant validity (using known-group comparisons). Group 1 data were used to assess responsiveness and group 2 data to determine test-retest reliability using intra-class correlations (ICC). Results: All 34 items fulfilled the criteria to be kept in the questionnaire. Cronbach's alpha was >0.70 in 8 of the 9 multi-item scales. All standardized factor loadings exceeded 0.40, confirming the proposed scale structure. The ICC was >0.70 in all scales expressing good test-retest reliability. Differences in scale scores between patients with different histology were >5 points in all scales. In all but one of the pre-specified scales (Dry Mouth), changes over time were ≥|4| points between at least two time points. Conclusion: The EORTC QLQ-THY34 with its 9 multi-item and 8 single-item scales is a reliable and valid tool to measure quality of life in thyroid cancer patients and can be used in future trials and studies.

Head and neck specific Health Related Quality of Life scores predict subsequent survival in successfully treated head and neck cancer patients: a prospective cohort study.

To examine the survival prediction of head and neck (H&N) Health Related Quality of Life (HRQoL) scores among successfully treated and cognitive functioning H&N squamous cell carcinoma (HNSCC) patients. Through structured interviews, self-reported questionnaires were given to 139 successfully treated HNSCC patients, 67 ± 32 months following diagnosis. HRQoL-scores, measured with the EORTC QLQ-H&N35 inventory, self-reported levels of neuroticism, avoidance focused coping, coping by suppression of competing activity, alcohol consumption, smoking status, and heart and lung disease, as well as gender, age, TNM-stage, and tumor site were determined. The mean observation period was 75 ± 4 months among the survivors. Twenty-four deaths were observed. A EORTC QLQ-H&N 35 sum score, including a dichotomized version (HR 2.73-3.67), was predictive of survival, both directly and after adjustment for all of the above mentioned variables. The H&N HRQoL indices "feeling ill", "sexuality", "open mouth", "swallowing", and "pain" specifically predicted survival. The dichotomized H&N HRQoL sum score compared the 4th upper quartile to the three lower quartiles, and a cut off value of 28.5 was designated. Analyses demonstrated that a high risk group with 33% mortality may include only one quarter of the patient population as opposed to 12.5% mortality among the other patients. Our findings indicate a unique survival prediction from EORTC QLQ-H&N 35 sum scores in successfully treated HNSCC patients. HRQoL scores, in particular, related to oral health, predicted survival. Furthermore, HRQoL-scores may be a screening tool for identifying patients with high mortality risk.