The EORTC QLQ-ELD14 questionnaire for elderly cancer patients. Validation study for elderly Spanish breast cancer patients / El cuestionario EORTC QLQ-ELD14 para pacientes mayores con cáncer. Estudio de validación en pacientes con cáncer de mama

Background and objectives: Quality of life (QoL) is a key outcome for elderly cancer patients. The EORTC has developed QLQ-ELD14, a questionnaire that assesses important age-specific issues for older patients with cancer. This study aims to validate QLQ-ELD14 for use with elderly Spanish breast cancer patients. Materials and methods: A consecutive sample of breast cancer patients with localized disease (age ≥65) who had received surgery ≥5 years earlier, were disease-free, and may have received adjuvant treatments was included. Patients completed the QLQ-ELD14, QLQ-C30 and QLQ-BR23 questionnaires. A subsample of patients completed QLQ-ELD14 six months later. Psychometric evaluation of the structure, reliability and validity of QLQ-ELD14 was conducted. Results: 87 patients completed the first assessment and 30 the second. Multitrait scaling analysis showed that all items except two met the standards for convergent and divergent validity. Cronbach's coefficient met the 0.7 alpha criterion on all scales except worries about others. Areas of QLQ-ELD14 and QLQ-C30 whose contents are conceptually related correlated substantially (Spearman's Rho >0.40). Conversely, areas of QLQ-ELD14 that had less in common with those of QLQ-C30 and QLQ-BR23 had low correlations (Spearman's Rho <0.1). Differences in QLQ-ELD14 were found in groups based on age, disease duration, living arrangement, presence of limiting comorbidity, and level of performance status. Patients had a higher level of worries at the second assessment. Conclusions: QLQ-ELD14 is a reliable and valid instrument when applied to a sample of Spanish patients. Our results are in line with those of other validation studies

Antecedentes y objetivos: La Calidad de Vida (CV) es un resultado importante en los pacientes mayores con cáncer. La EORTC ha desarrollado el QLQ-ELD14, cuestionario que evalúa aspectos importantes específicos en mayores con cáncer. Se pretende validar el QLQ-ELD14 para su aplicación en pacientes mayores con cáncer de mama. Materiales y métodos: Una muestra consecutiva de pacientes con cáncer de mama y enfermedad localizada (edad≥65) que habían recibido cirugía≥5 años antes, y podían haber recibido tratamientos adyuvantes fue incluida. Las pacientes han contestado los cuestionarios QLQ-ELD14, QLQ-C30 y QLQ-BR23. Una submuestra el cuestionario QLQ-ELD14 6 meses después. Se ha evaluado la estructura, la fiabilidad y la validez del cuestionario QLQ-ELD14. Resultados: Ochenta y siete pacientes han contestado la primera medición y 30 la segunda. El análisis multirrasgo-multimétodo ha mostrado que todos los ítems excepto 2 presentaban valores adecuados de validez convergente y divergente. Todas las escalas, excepto preocupación por los otros, satisfacían el criterio de Alfa de Cronbach 0.7. Áreas del QLQ-ELD14 y QLQ-C30 cuyo contenido estaba más relacionado presentaban correlaciones altas (Rho de Spearman>0,40). Áreas del QLQ-ELD14 menos relacionadas con el QLQ-C30 y QLQ-BR23 presentaban correlaciones más bajas (Rho de Spearman<0,1). Se han encontrado diferencias significativas en el QLQ-ELD14 entre grupos basados en edad, duración de la enfermedad, convivencia, comorbilidad y estado funcional. Las pacientes presentaban un nivel mayor de preocupaciones en la segunda medición. Conclusiones: El cuestionario QLQ-ELD14 es un instrumento fiable y válido en su aplicación a pacientes españoles. Nuestros resultados van en la línea de otros estudios de validación

The EORTC QLQ-ELD14 questionnaire for elderly cancer patients. Validation study for elderly Spanish breast cancer patients.

BACKGROUND AND OBJECTIVES: Quality of life (QoL) is a key outcome for elderly cancer patients. The EORTC has developed QLQ-ELD14, a questionnaire that assesses important age-specific issues for older patients with cancer. This study aims to validate QLQ-ELD14 for use with elderly Spanish breast cancer patients. MATERIALS AND METHODS: A consecutive sample of breast cancer patients with localized disease (age ≥65) who had received surgery ≥5 years earlier, were disease-free, and may have received adjuvant treatments was included. Patients completed the QLQ-ELD14, QLQ-C30 and QLQ-BR23 questionnaires. A subsample of patients completed QLQ-ELD14 six months later. Psychometric evaluation of the structure, reliability and validity of QLQ-ELD14 was conducted. RESULTS: 87 patients completed the first assessment and 30 the second. Multitrait scaling analysis showed that all items except two met the standards for convergent and divergent validity. Cronbach's coefficient met the 0.7 alpha criterion on all scales except worries about others. Areas of QLQ-ELD14 and QLQ-C30 whose contents are conceptually related correlated substantially (Spearman's Rho >0.40). Conversely, areas of QLQ-ELD14 that had less in common with those of QLQ-C30 and QLQ-BR23 had low correlations (Spearman's Rho <0.1). Differences in QLQ-ELD14 were found in groups based on age, disease duration, living arrangement, presence of limiting comorbidity, and level of performance status. Patients had a higher level of worries at the second assessment. CONCLUSIONS: QLQ-ELD14 is a reliable and valid instrument when applied to a sample of Spanish patients. Our results are in line with those of other validation studies.

Quality of life evolution in elderly survivors with localized breast cancer treated with radiotherapy over a three-year follow-up.

PURPOSE: This paper studies the Quality of Life (QL) of elderly early-stage breast cancer survivors. The aims are to compare the QL scores of these patients after follow-up with their scores before the start of radiotherapy (RT) and compare QL among different axillary treatment groups. METHODS: Of 173 patients over 65 who began treatment and completed the EORTC QLQ-C30 and QLQ-BR23 and the Interview for Deterioration in Daily Living Activities in Dementia (IDDD) before RT, 138 also completed these questionnaires three years after RT. Longitudinal changes in QL were assessed for the whole sample using linear mixed-effect models. Also assessed were differences in QL scores between axillary treatment groups (axillary node dissection ALND, sentinel lymph node biopsy SLNB, and no surgery) at the end of the follow-up (Anova or Kruskal-Wallis) and differences in the evolution of QL from baseline among these groups (linear regression models). RESULTS: QL scores in the follow-up were high (>70/100 points) in most QL areas, with moderate limitations (>30) in sexual functioning and enjoyment. Five areas (pain, nausea/vomiting, financial impact, breast symptoms and IDDD) improved significantly (<6 points) in the follow-up. The ALND group scored less for the future perspective item (15-20 points) in the follow-up than the other two axillary treatment groups. No differences between the pre-treatment and follow up assessments regarding treatment were found among the axillary treatment groups. CONCLUSIONS: Our results suggest that early-stage breast cancer patients adapted well both to their disease and treatments over the follow-up period and to the administration of RT. There were few QL differences between the axillary treatment groups.

An evaluation study of the determinants of future perspective and global Quality of Life in Spanish long-term premenopausal early-stage breast cancer survivors.

AIM OF THE STUDY: Quality of life (QL) is important in premenopausal long-term breast cancer survivors. In this study we assessed QL and factors associated with future perspective and global QL in premenopausal early-stage long-term breast cancer survivors from Spain. MATERIAL AND METHODS: 243 premenopausal stage I-IIIA relapse-free breast cancer patients who had received surgery 5-20 years previously completed EORTC QLQ-C30 and QLQ-BR23 questionnaires once during follow-up. Univariate and multivariate logistic regression analyses were performed. RESULTS: QL mean scores were high in most areas (> 80 in functioning; < 20 in symptoms). The main factors for future perspective were emotional and social functioning, fatigue, breast symptom, and body image. The main factors for global QL were fatigue, pain and physical functioning, and emotional and social functioning. The best logistic model to explain future perspective associated high emotional and social functioning and low breast symptoms with a lower risk of low future perspective (R(2) = 0.56). Higher scores in physical and emotional functioning and lower scores in fatigue were associated with a lower risk of low global QL (R(2) = 0.50). CONCLUSIONS: Psychological, social, and physical factors were found to be possible determinants of global QL and future perspective. QL in premenopausal early-stage long-term breast cancer survivors may benefit from multidisciplinary treatment.

Quality of life in elderly patients with localized breast cancer treated with radiotherapy. A prospective study.

PURPOSE: There is a debate on the role of adjuvant Radiotherapy (RT) in elderly breast cancer patients. The aim is to study Quality of Life (QL) throughout the treatment and follow-up periods in early stages breast cancer patients who have started radiotherapy, and to compare the QL of axillary surgery groups. METHODS: 173 patients, ≥65 years completed the EORTC QLQ-C30 and QLQ-BR23, and the Interview for Deterioration in Daily Living Activities in Dementia(IDDD) questionnaires three times throughout treatment and follow-up periods. Linear mixed effect models were used to evaluate longitudinal changes in QL, and whether these changes differed among axillary surgery groups. RESULTS: QL scores were high (>70/100 points) in most QL areas, with moderate limitations (>30) in sexual functioning and enjoyment, future perspective and global QL. In six areas there was a decline at the RT sessions end, that after 6 weeks was recovered. For three areas, there was an improvement in the follow-up measurement compared to the previous assessments. Changes in seven areas were <5 points. Axillary node dissection patients had a body image decrease (6 points) in the follow up period. The lymphadenectomy group had more fatigue (10 points, p = 0.078) than the other two axillary surgery groups. CONCLUSIONS: Results orientate towards good patients' adaptation to their disease and treatments, and to administering RT in early stages breast cancer patients. QL differences between the axillary surgery groups and in their evolutions were few but have appeared in key QL areas.

Current Status of Radiotherapy for the Management of Regional Nodes in Breast Cancer.

Worldwide, breast cancer is the most common invasive cancer in women. Breast cancer constitutes about 23% of invasive cancers in women. The management of breast cancer depends on various factors, including the cancer stage and patient age. Breast cancer is usually treated with surgery, which can be followed by chemotherapy or radiation therapy, or both. Until recently, the standard procedure for axillary study was axillary dissection. Sentinel lymph node biopsy has been validated as a less-aggressive axillary treatment without an impact on survival. In the present report, we review the current management of the axillary lymph nodes, especially from the viewpoint of an oncology radiotherapist.

Quality of life and voice assessment in patients with early-stage glottic cancer.

BACKGROUND: The purpose of this study was to assess the quality of life (QOL) and voice handicap in a sample of disease-free patients who had been treated at our center with radiotherapy (RT) or surgery for early glottic cancer. METHODS: QOL and voice handicap were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires Quality of Life Questionnaire-Core 30-questions (QLQ-C30) and Quality of Life Questionnaire-Head and Neck 35-questions (QLQ-H&N35) and the Voice Handicap Index (VHI). RESULTS: Ninety-one patients completed the questionnaires. Fifty-nine patients (65%) were treated with RT and 32 (35%) with surgery. QOL scores for the sample recorded, moderate limitations in 6 areas, and more than moderate limitations (>30 of 100) in 2 areas. Significant differences were found in emotional functioning (88.5 vs 76.6) and social contact (4.6 vs 12.1) on the EORTC questionnaires and on the VHI (6.1 vs 12.8), which favored the RT group. CONCLUSION: In this cross-sectional study, voice quality, emotional functioning, and social contact were better in the RT group.

The EORTC QLQ-C15-PAL questionnaire: validation study for Spanish bone metastases patients.

PURPOSE: Quality of life (QL) is a key outcome for advanced disease cancer patients. The European Organization for Research and Treatment of Cancer (EORTC) has developed the QLQ-C15-PAL questionnaire, a short version of the QLQ-C30 for palliative care. The aim of the present study is to validate the QLQ-C15-PAL for use with Spanish patients with bone metastasis. METHODS: For this study, we used a consecutive sample of stage IV cancer patients with bone metastases who started radiotherapy with palliative intention. Two assessments were proposed for each patient: one on the first day of treatment and one a month after the end of the radiotherapy sessions. Psychometric evaluation of the structure, reliability, and validity was undertaken. RESULTS: One hundred and sixteen patients completed the first questionnaire and seventy five completed the second. Multitrait scaling analysis showed that all items met the standards for convergent validity, and all except the fatigue scale met the standards for divergent validity. Cronbach's coefficient met the 0.7 alpha criterion on all scales except pain (second assessment). Most QLQ-C15-PAL areas had low-to-moderate correlations with the other areas. Significant differences appeared in the comparisons between groups with regard to: patients who died before the second assessment (six areas); patients receiving chemotherapy before starting radiotherapy in the two assessments (three and four areas, respectively); the performance status in the two assessments (nine and eight areas); and the number of RT sessions received (four). Quality of life was better in the second assessment in nine areas. CONCLUSION: The QLQ-C15-PAL is a reliable and valid instrument when applied to a sample of Spanish patients. These results are in line with those of other validation studies.

The EORTC information questionnaire, EORTC QLQ-INFO25. Validation study for Spanish patients.

INTRODUCTION: The EORTC QLQ-INFO25 evaluates the information received by cancer patients. This study assesses the psychometric properties of the QLQ-INFO25 when applied to a sample of Spanish patients. MATERIALS AND METHODS: A total of 169 patients with different cancers and stages of disease completed the EORTC QLQINFO25, the EORTC QLQ-C30 and the information scales of the inpatient satisfaction module EORTC IN-PATSAT32 on two occasions during the patients' treatment and follow- up period. Psychometric evaluation of the structure, reliability, validity and responsiveness to changes was conducted. Patient acceptability was assessed with a debriefing questionnaire. RESULTS: Multi-trait scaling confirmed the 4 multi-item scales (information about disease, medical tests, treatment and other services) and eight single items. All items met the standards for convergent validity and all except one met the standards of item discriminant validity. Internal consistency for all scales (α>0.70) and the whole questionnaire (α>0.90) was adequate in the three measurements, except information about the disease (0.67) and other services (0.68) in the first measurement, as was test-retest reliability (intraclass correlations >0.70). Correlations with related areas of IN-PATSAT32 (r>0.40) supported convergent validity. Divergent validity was confirmed through low correlations with EORTC QLQ-C30 scales (r<0.30). The EORTC QLQ-INFO-25 discriminated among groups based on gender, age, education, levels of anxiety and depression, treatment line, wish for information and satisfaction. One scale and an item showed changes over time. CONCLUSIONS: The EORTC QLQ-INFO 25 is a reliable and valid instrument when applied to a sample of Spanish cancer patients. These results are in line with those of the EORTC validation study.

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)

Impact of radiotherapy on the quality of life of elderly patients with localized breast cancer. A prospective study.

INTRODUCTION: There are few studies on the effect on quality of life (QL) of cancer-related illness and treatment in elderly patients. The aim of this work was to evaluate prospectively QL in a sample of elderly patients with stages I.III breast cancer who started radiotherapy treatment and compare their QL with that of a sample of younger patients. MATERIALS AND METHODS: Forty-eight patients, > or = 65 years of age completed the European Organization for Research and Treatment of Cancer (EORTC) QL questionnaires QLQ-C30 and QLQ-BR23, and the Interview for Deterioration in Daily Living Activities in Dementia (IDDD) daily activities scale three times throughout treatment and follow-up periods. Clinical and demographic data were also recorded. Fifty patients ages 40-64 years with the same disease stage and treatment modality had previously completed the QL questionnaires. QL scores, changes in them among the three assessments, differences between groups based on clinical factors, and differences between the two samples were calculated. RESULTS: QL scoring was good and stable (>70/100 points) in most areas, in line with clinical data. Light and moderate limitations occurred in global QL and some emotional, sexual, and treatment-related areas. Moderate decreases (10-20) appeared in some toxicity-related areas, which recovered during the follow-up period. Breast-conservation and sentinel-node patients presented higher scores in emotional areas. There were few QL differences among agebased samples. CONCLUSIONS: QL and clinical data indicate radiotherapy was well tolerated. Age should not be the only factor evaluated when deciding upon treatment for breast cancer patients.

Progresos en la evaluación de la calidad de vida en el cáncer de mama. El sistema de medida de la EORTC / Progress in quality of life assessment of breast cancer. The, measurement system of EORTC

Este trabajo pretende presentar la situación actual de la evaluación de la Calidad de Vida en el cáncer de mama. Esta es la localización tumoral de la que se han realizado más estudios de Calidad de Vida. Su valoración es de gran utilidad en la práctica clínica, en los ensayos clínicos con dicha enfermedad y en la propia adaptación de las pacientes a su situación, incluyendo la toma de decisiones. Se prestan el sistema de medida de la EORTEC para cáncer de mama, y otros dos instrumentos de cáncer de mama y otros dos instrumentos de evaluación. Se da atención especial a la áreas de la medición de la Calidad de Vida en dicha enfermedad, en las que entendemos se están dando más avances en la actualidad; la biopsia del ganglio centinela, los tipos de cirugía, la experiencia de las pacientes mayores, las diferencias entre grupos de edad, y los estudios de seguimiento a largo plazo (AU)

The aim of the present work is to present the situation of Quality of Life assessment in breast cancer. Breast cancer is the tumour site in which more Quality of Life studies have been carried out. Quality of Life assessment can be quite useful in clinical practice, clinical trials and in the patients´ adaptation process to their situation, including decision making. The EORTC assessment system for breast cancer and two other instruments are presented. Special attention is paid to the Quality of Life assessment areas in which we consider that more progress is being performed nowadays; the sentinel node biopsy, the different surgery modalities, the experience of elderly patients, the differences among age based groups, and the long term follow-up studies (AU)

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