The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients.

OBJECTIVE: The EORTC Quality of Life Group has developed a questionnaire for evaluating Quality of Life in international clinical trials: EORTC QLQ-C30, which is widely used in many countries. The purpose of this study was to assess the psychometric properties of the third version of this questionnaire, EORTC QLQ-C30 (version 3.0), when applied to Spanish prostate cancer patients. METHODS: A sample of 137 prostate cancer patients prospectively filled in the questionnaire three times: on the first and last day of the treatment, and in the followup period. Psychometric evaluation of the structure, reliability and validity was made. RESULTS: Multitrait scaling analysis showed that most item-scale correlation coefficients met the standards of convergent and discriminant validity. Few exceptions appeared mainly in CF Most scales had low to moderate inter-correlations. Cronbach's coefficients of the scales were above 0.7, except for the CF and NV values. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in functioning and symptom areas appeared throughout the different measurements, which were in line with the treatment process. CONCLUSIONS: The EORTC QLQC30 (version 3.0) appeared as a reliable and valid instrument when applied to a sample of Spanish prostrate cancer patients. The results are in line with previous studies.

The EORTC Quality of life questionnaire OLO-C30 (version 3.0). Validation study for Spanish prostate cancer patients / Cuestionario de calidad de vida QLQ-C30 (versión 3.0): Estudio de validación en español con pacientes con cáncer de próstata

Objective: The EORTC Quality of Life Group has developed a questionnaire for evaluating Quality of Life in international clinical trials: EORTC QLQ-C30, which is widely used in many countries. The purpose of this study was to assess the psychometric properties of the third version of this questionnaire, EORTC QLQ-C30 (version 3.0), when applied to Spanish prostate cancer patients. Methods: A sample of 137 prostate cancer patients prospectively filled in the questionnaire three times: on the first and last day of the treatment, and in the follow-up period. Psychometric evaluation of the structure, reliability and validity was made. Results: Multitrait scaling analysis showed that most item-scale correlation coefficients met the standards of convergent and discriminant validity. Few exceptions appeared mainly in CF. Most scales had low to moderate inter-correlations. Cronbach's coefficients of the scales were above 0.7, except for the CF and NV values. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in functioning and symptom areas appeared throughout the different measurements, which were in line with the treatment process. Conclusions: The EORTC QLQ-C30 (version 3.0) appeared as a reliable and valid instrument when applied to a sample of Spanish prostrate cancer patients. The results are in line with previous studies (AU)

Objetivo: El Grupo de Calidad de Vida de la EORTC ha desarrollado un cuestionario para evaluar la Calidad de Vida en ensayos clínicos internacionales: EORTC QLQ-C30, el cual es ampliamente utilizado en muchos países. El objetivo de este trabajo es evaluar las propiedades psicométricas de la tercera versión de este cuestionario, EORTC QLQ-C30 (versión 3.0), al ser administrado a pacientes españoles con cáncer de próstata. Métodos: Una muestra de 137 pacientes con cáncer de próstata han contestado el cuestionario de forma prospectiva tres veces: el primer y último día de tratamiento, y durante el período de seguimiento. Se ha realizado una evaluación psicométrica de su estructura, fiabilidad y validez. Resultados: los análisis multirasgo-multimétodo han mostrado que la mayoría de las correlaciones ítem-escala satisfacían los criterios de validez convergente y divergente. Se han dado pocas excepciones, principalmente en la escala CF. La mayoría de las correlaciones entre escalas eran bajas o moderadas. Los coeficientes Alpha de Cronbach de las escalas eran superiores a 0,7, excepto en las escalas CF y NV. Los análisis de comparación entre grupos han indicado que se da una mejor Calidad de Vida en pacientes con mayor performance status. Se han dado cambios en áreas de funcionamiento y de síntomas a lo largo de las diferentes medidas, que han ido en línea con el proceso de tratamiento. Conclusiones: el EORTC QLQ-C30 (versión 3.0) se ha mostrado como un instrumento fiable y válido al ser aplicado a una muestra de pacientes españoles con cáncer de próstata. Los resultados van en línea con los estudios de validación previos (AU)

Quality of life in patients with locally advanced head and neck cancer treated with chemoradiotherapy. Comparison of two protocols using the EORTC questionnaires (QLQ-C30, H and N35).

INTRODUCTION: The objective of this study is to assess the quality of life (QoL) of two groups of patients during treatment for locally advanced head and neck (H and N) cancer. MATERIAL AND METHODS: Two samples of 30 patients each in AJCC stages III and IV undergoing either of two chemo-radiotherapy protocols completed the EORTC QLQ-C30 general questionnaire and the QLQ-H and N35 H and N module on three occasions during the treatment and follow-up periods. We also collected clinical data. The QoL scores and their evolution over the three measurements were calculated and both protocols were compared during the treatment period. RESULTS: The QoL scores are acceptable in general. Limitations were observed in relation to toxicity, psycho-social and some functional areas during the treatment. QoL improved in the follow-up period. The clinical and QoL data are better in one of the two treatment protocols. DISCUSSION: The QoL scores indicate that the condition of the patients receiving the protocols was acceptable, considering the severity of their disease. The treatments were reasonably-well tolerated.

Quality of life in patients with locally advanced head and neck cancer treated with chemoradiotherapy. Comparison of two protocols using the EORTC questionnaires (QLQ-C30, H&N35)

Introduction. The objective of this study is to assess the quality of life (QoL) of two groups of patients during treatment for locally advanced head and neck (H&N) cancer. Material and methods. Two samples of 30 patients each in AJCC stages III and IV undergoing either of two chemo-radiotherapy protocols completed the EORTC QLQ-C30 general questionnaire and the QLQ-H&N35 H&N module on three occasions during the treatment and follow-up periods. We also collected clinical data. The QoL scores and their evolution over the three measurements were calculated and both protocols were compared during the treatment period. Results. The QoL scores are acceptable in general. Limitations were observed in relation to toxicity, psycho-social and some functional areas during the treatment. QoL improved in the follow-up period. The clinical and QoL data are better in one of the two treatment protocols. Discussion. The QoL scores indicate that the condition of the patients receiving the protocols was acceptable, considering the severity of their disease. The treatments were reasonably-well tolerated

Concomitant boost radiation and concurrent cisplatin for advanced head and neck carcinomas. Preliminary results of a phase II, single-institutional trial.

INTRODUCTION: This study aims to asses the effectiveness and toxicity of boost radiotherapy concomitant and concurrent cisplatin for patients with locally advanced head and neck cancer (LAHNC). MATERIAL AND METHODS: There were 30 patients included in a prospective, phase II single-institution trial and of whom, 29 were at AJCC stage IV and 1 at stage III. Treatment consisted of radiotherapy acceleration fractionation with concomitant boost, 72 Gy, and 2 cycles of concomitant cisplatin (20 mg/m2/day continuous infusion; days 1-5 and 29-33). Amifostine, (i.v. 200 mg/m2) was administered to 26 prior to the first fraction of radiotherapy. Endpoints of the study were quality-of-life (QL), overall survival, and local control of disease. RESULTS: Complete response (CR) was achieved in 23 patients (77%), 2 patients had partial response (PR) (7%), 4 had no response (13%), and 1 was not evaluated for response. The 2-year overall survival and loco-regional control were 60% and 56%, respectively. Main toxicity was grade 3 or 4 mucositis in 93% of the patients. QL scores (questionnaire QLQC30; version 3.0) and the HN cancer module QLQ-HN35) showed a worsening in areas related to the treatment e.g. dry mouth, problems stretching the mouth, and sticky saliva. CONCLUSIONS: this combination modality is active, but toxic, in the treatment for LAHNC. Concomitant boost radiotherapy is probably, not the best radiotherapy schema for combining with chemotherapy in LAHNC.

Concomitant boost radiation and concurrent cisplatin for advanced head and neck carcinomas. Preliminary results of a phase II, single-institutional trial

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Introduction. This study aims to asses the effectiveness and toxicity of boost radiotherapy concomitant and concurrent cisplatin for patients with locallyadvanced head and neck cancer (LAHNC). Material and methods. There were 30 patients included in a prospective, phase II single-institution trial and of whom, 29 were at AJCC stage IV and 1 at stage III. Treatment consisted of radiotherapyacceleration fractionation with concomitant boost, 72 Gy, and 2 cycles of concomitant cisplatin (20 mg/m2/day continuous infusion; days 1-5 and 29-33). Amifostine, (i.v. 200 mg/m2) was administered to 26 prior to the first fraction of radiotherapy. Endpoints of the study were quality-of-life (QL), overall survival, and local control of disease. Results. Complete response (CR) was achievedin 23 patients (77%), 2 patients had partial response (PR) (7%), 4 had no response (13%), and 1 was not evaluated for response. The 2-year overall survival and loco-regional control were 60% and 56%, respectively. Main toxicity was grade 3 or 4 mucositis in 93% of the patients. QL scores (questionnaire QLQC30; version 3.0) and the HN cancer module QLQ-HN35) showed a worsening in areas related to thetreatment e.g. dry mouth, problems stretching the mouth, and sticky saliva. Conclusions. this combination modality is active, but toxic, in the treatment for LAHNC. Concomitant boost radiotherapy is probably, not the best radiotherapy schema for combining with chemotherapy in LAHNC