Background The recognition of patient-reported outcomes for oral cancer is important in improving patients’ quality of life. The aim of this study was to translate and validate the modified Sinhala version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oral Health Module (EORTC QLQ-OH15). Methods A cross-sectional study was conducted to validate the EORTC QLQ-OH15 that was modified after adding two questions to the original questionnaire. The two questions added were ‘difficulty in opening the mouth wide’ and ‘trouble with talking’ which affect oral health related quality of life (OHRQOL) of oral cancer patients receiving radiotherapy. The Sinhala translated modified EORTC QLQ-OH15 and already validated the core questionnaire EORTC QLQ-C30 were self-completed by 85 adult oral cancer patients who received initial anti-cancer treatment with radiotherapy with or without chemotherapy. Content and face validity were examined by an expert panel. Construct validity was confirmed by using factor analysis, multi-trait scaling analysis, and known group comparison. Reliability was assessed by internal consistency, test–retest reliability by Wilcoxon Signed Ranks Test and intra class correlation coefficient. Responsiveness to change was assessed. Results The majority of participants (58%) were aged 50–69 years and 84% were males. Nearly 32% had cancer of the anterior two thirds of the tongue. Of the sample, 66% received chemo radiotherapy. Thirteen items were included for the factor analysis. They were loaded for four factors. Three scales ‘Eating problem’, ‘Gum and Speech problem’ and ‘Soreness’ loaded with 5, 4 and 3 items respectively and single item ‘teeth’ to a one factor with the total variance explained was 72.74%. Mann–Whitney U tests for all three scales were statistically significant confirming the ability of the modified EORTC QLQ-OH15 to detect expected differences in OHRQOL in clinically different groups. Cronbach’s alpha for all the scales were more than 0.8. Wilcoxon Matched Paired Sign Rank Test showed highly significant results (p < 0.05) for all three scales revealing high responsiveness. Conclusions The modified Sinhala version of the EORTC QLQ-OH15 is a valid, reliable tool that can be used to measure OHRQOL in oral cancer patients who receive radiotherapy with or without chemotherapy.

Background: The recognition of patient-reported outcomes for oral cancer is important in improving patients’ quality of life. The aim of this study was to translate and validate the modified Sinhala version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oral Health Module (EORTC QLQ-OH15).Methods: A cross sectional study was conducted to validate the EORTC QLQ-OH15 that was modified after adding two questions to the original questionnaire. The two questions added were ‘difficulty in opening the mouth wide’ and ‘trouble with talking’ which affect oral health related quality of life (OHRQOL) of oral cancer patients receiving radiotherapy. The Sinhala translated modified EORTC QLQ-OH15 and the core questionnaire EORTC QLQ-C30 were self-completed by 85 adult oral cancer patients who received initial anti-cancer treatment with radiotherapy with or without chemotherapy.Face, consensual and content validity were examined by the appearance. Construct validity was confirmed by using factor analysis, multi-trait scaling analysis, and known group comparison. Reliability was assessed by internal consistency, test-retest reliability and intra class correlation coefficient. Responsiveness to change was assessed.Results: The majority of participants (58%) were aged 50-69 years and 84% were males. Nearly 32% had cancer of the anterior two thirds of the tongue. Of the sample, 66% received chemo radiotherapy. Thirteen items were included for the factor analysis. They were loaded for four factors. Three scales ‘Eating problem’, ‘Gum and Speech problem’ and ‘Soreness’ loaded with 5, 4 and 3 items respectively and single item ‘teeth’ to a one factor with the total variance explained was 72.74%.Mann–Whitney U tests for all three scales were statistically significant confirming the ability of the modified EORTC QLQ-OH15 to detect expected differences in OHRQOL in clinically different groups. Cronbach’s alpha for all the scales were more than 0.8. Wilcoxon Matched Paired Sign Rank Test showed highly significant results (p<0.05) for all three scales revealing high responsiveness. Conclusion: The modified Sinhala version of the EORTC QLQ-OH15 is a valid, reliable tool that can be used to measure OHRQOL in oral cancer patients who receive radiotherapy with or without chemotherapy.

Background Oral cancer is the number one cancer among males in Sri Lanka. Radiotherapy is a common treatment modality for oral cancer, but this can affect oral health related quality of life (OHRQOL). This study assessed the OHRQOL and its changes from baseline to the last week of radiotherapy and three months post radiotherapy among oral cancer patients who received this treatment alone or with chemotherapy. Methods A prospective longitudinal study was conducted among 90 oral cancer patients awaiting for radiotherapy alone or with chemotherapy. The modified Sinhala version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oral Health Module (EORTC QLQ-OH15) was used to gather data related to OHRQOL before radiotherapy. Socio-demographic and clinical data were also recorded. The same cohort of patients were followed up and assessed their OHRQOL during the last week of radiotherapy and three months post radiotherapy. The Modified EORTC QLQ-OH15 assesses the OHRQOL under three domains namely ‘Eating problem’, ‘Gum and speech problem’ and ‘Soreness’, and one item named as ‘Teeth’. Results The majority of the sample (88%) was males. The anterior two-thirds of the tongue (40%) and buccal mucosa (22%) were the most common sites. The median scores of ‘Eating problem’ domain at baseline, last week of radiotherapy and three months post radiotherapy were 20 (IQR = 6.7–33.3), 100 (IQR = 86.9–100.0) and 66.7 (IQR = 46.7–93.3) respectively. ‘Gum and speech problem’ was higher during last week of radiotherapy (median, 50.0, IQR, 25.0-58.3) than three months post radiotherapy (median, 8.3, IQR, 0.0-33.3). The changes of OHRQOL between the time frames were statistically significant (p < 0.05). Baseline OHRQOL in relation to ‘Gum and speech problem’ domain and ‘Teeth’ item was identified as an influential factor for OHRQOL during last week of radiotherapy. Conclusion The OHRQOL of oral cancer patients who received radiotherapy alone or with chemotherapy had deteriorated from the baseline level to the last week of radiotherapy but then improved at three months post radiotherapy. The OHRQOL however did not return to the baseline level three months post radiotherapy. OHRQOL during the last week of radiotherapy was influenced by the OHRQOL at baseline, civil status and sites of metastasis.

Background Oral cancer is the number one cancer in males in Sri Lanka. Radiotherapy is a common treatment modality for oral cancer, but this can affect oral health related quality of life (OHRQOL). This study assessed the OHRQOL and its changes from baseline to the last week of radiotherapy and three months post radiotherapy among oral cancer patients who received this treatment alone or with chemotherapy. Methods A prospective longitudinal study was conducted among 90 oral cancer patients waiting for radiotherapy alone or with chemotherapy. The modified Sinhala version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oral Health Module (EORTC QLQ-OH15) was used to gather data related to OHRQOL before radiotherapy, during the last week of radiotherapy and three months after completion of radiotherapy. Socio-demographic and clinical data were also recorded. Results The majority of the sample (88%) were males. The anterior two-thirds of the tongue (40%) and buccal mucosa (22%) were the most common sites of oral cancer. The median scores of ‘Eating problem’ domain at baseline, last week of radiotherapy and three months after radiotherapy were 20 (IQR = 6.7–33.3), 100 (IQR = 86.9–100.0) and 66.7 (IQR = 46.7–93.3) respectively. ‘Gum and speech problem’ was higher during last week of radiotherapy (median, 50.0, IQR, 25.0-58.3) than three months post radiotherapy (median, 8.3, IQR, 0.0-33.3). The changes in the ‘Eating problem’, ‘Gum and speech problem’ and ‘Soreness’ domains and the item ‘Teeth’ between the time frames were statistically significant. Conclusion The OHRQOL of oral cancer patients who received radiotherapy alone or with chemotherapy had deteriorated from the baseline level to the last week of radiotherapy but then improved at three months post radiotherapy. The OHRQOL however did not return to the baseline level three months post RT.