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 for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients.

INTRODUCTION: The EORTC Quality of Life (QL) Group has developed a questionnaire -the EORTC QLQ-CR29- for evaluating QL in colorectal cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQCR29 when applied to a sample of Spanish patients. MATERIALS AND METHODS: Eighty-four locally advanced rectal cancer patients in the treatment follow-up period after receiving surgery and neoadjuvant chemoradiotherapy were included in the study. Seventy subjects also had adjuvant chemotherapy. Patients completed both the EORTC QLQC30 and the QLQ-CR29 once. The psychometric evaluation of the questionnaire's structure, reliability, and convergent, divergent and known-groups validity was performed. RESULTS: Multitrait scaling analysis showed that three of the multi-item scales met the standards of convergent and discriminant validity. These same scales reached the 0.7 Cronbach's coefficient criterion or were close to it. In both analyses exceptions were observed in the blood and mucus in stool scale. Correlations between the scales of the QLQC30 and the module were low (r<0.02) in most cases. A few areas with more related content had higher correlations (r<0.05). Group comparison analyses showed differences in QL between groups of patients based on age, comorbidity, performance status, receipt of adjuvant chemotherapy and surgery modality. CONCLUSIONS: The EORTC QLQ-CR29 is a reliable and valid instrument when applied to a sample of Spanish rectal cancer patients. These results are in line with those of the EORTC validation study.

Quality of Life assessment through the EORTC questionnaires of colorectal cancer patients in advanced disease stages.

PURPOSE: The purpose of the present work is to evaluate Quality of Life in a group of colorectal cancer patients in advanced stages of their disease, along a standard chemotherapy treatment protocol, through the EORTC core questionnaire QLQ-C30 and the colorectal cancer module QLQ-CR38. These two questionnaires had previously been validated in our country. The present study has the novelty of its use during the chemotherapy treatment. MATERIALS AND METHODS: A consecutive sample of 44 colon o rectal cancer patients in stage IV, from an initial group of 46 patients who were addressed, have filled in the questionnaires, in three moments during their treatment process. Clinical and demographic data have also been recorded. Quality of Life scores and changes in them among the three assessments have been calculated. RESULTS: The quality of life scores of patients who have followed the treatment have been >70 points (100) in most dimensions, and has shown similar to the clinical data. Changes of >20 points in the quality of life scores during the treatment process appear in areas related to toxicity, fatigue and insomnia. Quality of life has been stable or has had small changes (between 10 and 20 points) in most dimensions. CONCLUSIONS: Quality of Life in the present sample has been good in general. The treatment has been administered to patients who could tolerate it adequately.

Quality of Life assessment through the EORTC questionnaires of locally advanced rectal cancer patients treated with preoperative chemo-radiotherapy.

PURPOSE: To assess the quality of life in a group of rectal cancer patients during the treatment period. MATERIAL AND METHODS: A sample of 83 rectal cancer patients in Dukes' stages B2 or C who started a chemoradiotherapy treatment followed by surgery, have filled in the EORTC core questionnaire QLQC30 and the colorectal module QLQ-CR38, in three moments during the treatment and follow-up periods: at the beginning of the treatment, at the end of the chemoradiotherapy, and after surgery. Clinical and demographic data have also been recorded. Quality of Life scores and changes in them among the three assessments have been calculated. RESULTS: Quality of life scores of patients who have followed the treatment has been good in most dimensions, and has shown similar to the clinical data. Soft and moderate alterations have appeared in the areas of disease symptoms, treatment toxicity, fatigue, emotional and sexual functioning, and also in functional areas after surgery. Quality of life has been stable or has had small changes in most dimensions. A worsening in toxicity areas has appeared after the neoadyuvant treatment. After surgery there has been a worsening in functional areas, fatigue and appetite loss, and an improvement in diarrhoea. CONCLUSIONS: Quality of life scores and clinical data indicate that the situation of the patients who have received the treatments has been good. Patients under treatment stood it adequately.

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.

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.