• Comparison of patient-reported late treatment toxicity (LENT-SOMA) with quality of life (EORTC QLQ-C30 and QLQ-H&N35) assessment after head and neck radiotherapy.

      Ho, Kean F; Farnell, Damian J J; Routledge, Jacqueline A; Burns, Meriel P; Sykes, Andrew J; Slevin, Nicholas J; Davidson, Susan E; Academic Radiation Oncology, University of Manchester, The Christie NHS Foundation Trust, Manchester, UK. (2010-06-14)
      PURPOSE: The patient's role in toxicity reporting is increasingly acknowledged but requires the adaptation and validation of toxicity reporting instruments for patient use as most toxicity scales are designed for physician use. Recording of radiotherapy related late toxicity is important and needs to be improved. A patient-scored symptom questionnaire of late treatment effects using LENT-SOMA was compared with a recognised quality of life tool (EORTC QLQ-C30/H&N35). MATERIALS/METHODS: LENT-SOMA and EORTC QLQ-C30 patient questionnaires were prospectively completed by 220 head and neck cancer patients over 3years and 72 completed EORTC QLQ-H&N35 questionnaires at 2years post-radiotherapy. RESULTS: Endpoints common to both questionnaires (pain, swallowing, dental pain, dry mouth, opening mouth, analgesics) were matched. Spearman rank correlation coefficients with rho>0.6 (P<0.001) were obtained for all "matched" scales except for analgesics scale, rho=0.267 (P<0.05). There was good agreement between LENT-SOMA and EORTC QLQ-H&N35 except for analgesic endpoints. Global quality of life scores correlated negatively with average LENT-SOMA scores (P<0.001). Significant differences in average LENT-SOMA scores between treatment modalities were found. The LENT-SOMA questionnaire has demonstrated a high Cronbach's alpha value (0.786) indicating good reliability. CONCLUSIONS: LENT-SOMA patient questionnaire results agreed well with those from the EORTC QLQ-H&N35 questionnaire for toxicity items where they could be compared explicitly, particularly for subjective endpoints. Patient-reported late toxicity had a negative impact on quality of life. The LENT-SOMA patient questionnaire is both reliable and sensitive to differences between patients treated with different modalities. A patient-based questionnaire is an important contributor to capturing late radiotherapy effects.
    • Developing a CTCAEs patient questionnaire for late toxicity after head and neck radiotherapy.

      Ho, Kean F; Farnell, Damian J J; Routledge, Jacqueline A; Burns, Meriel P; Sykes, Andrew J; Slevin, Nicholas J; Davidson, Susan E; Academic Radiation Oncology, University of Manchester, The Christie NHS Foundation Trust, Wilmslow Road, Manchester M20 4BX, United Kingdom. (2009-05-06)
      PURPOSE: Patient-based reporting of symptoms is increasingly important in providing treatment toxicity information. However, observer-based scoring systems such as the CTCAEs which incorporate the LENT-SOMA scales are not adapted for patient-based reporting. We aim to (1) report the late toxicity in patients following head and neck radiotherapy using a LENT-SOMA patient-based questionnaire, (2) describe how the responses help to improve the questionnaire and (3) adapt the questionnaire for patient reporting using CTCAEs. METHODS: A 31-item LENT-SOMA patient questionnaire was administered prospectively to 220 patients pre-treatment and at eight time periods post-radical head and neck radiotherapy over 3 years. Exploratory factor analysis was carried out and questionnaire reliability was evaluated using Cronbach's alpha coefficient. RESULTS: At 3-years follow-up, grade 3/4 toxicity was recorded for xerostomia (44%), hoarseness (14.3%), altered taste (6.1%) and oropharyngeal pain (1.9%). Factor analysis indicated that questionnaire division according to anatomical sub-site was reasonable. Cronbach's alpha was 0.851 (95% CI: 0.820-0.883) indicating high reliability. Good compliance was obtained with all questions except for the 'weight loss' item. A satisfaction survey showed that the questionnaire was clear and concise. Teeth and mandible sections have been removed. Dietary change due to xerostomia has been incorporated in line with CTCAEs. LENT-SOMA scoring of analgesic needs and dysphagia not described in CTCAEs were found useful and have been retained. CONCLUSIONS: The questionnaire has enabled reporting of late toxicity and the responses have enabled refinement of the questionnaire. It is reliable, feasible and has been validated for patient-based collection of CTCAEs late toxicity data.