General Spanish population normative data analysis for the EORTC QLQ-C30 by sex, age, and health condition.

PURPOSE: General population normative data for the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire facilitates interpretation of data assessed from cancer patients. This study aims to present normative data of the general Spanish population. METHODS/PATIENTS: Data were obtained from a prior larger study collecting EORTC QLQ-C30 norm data across 15 countries. Data were stratified by sex and age groups (18-39, 40-49, 50-59, 60-69 and > 70 years). Sex and age distribution were weighted according to population distribution statistics. Sex- and age-specific normative values were analysed separately, as were participants with versus those without health conditions. Multiple linear regression was used to estimate the association of each of the EORTC QLQ-C30 scales with the determinants age, sex, sex-by-age interaction term, and health condition. RESULTS: In total, 1,165 Spanish individuals participated in the study. Differences were found by sex and age. The largest sex-related differences were seen in fatigue, emotional functioning, and global QOL (Quality of Life), favouring men. The largest age differences were seen in emotional functioning, insomnia, and pain, with middle-aged groups having the worst scores. Those > 60 years old scored better than those < 60 years old on all scales except for physical functioning. Participants with no health conditions scored better in all QLQ-C30 domains. CONCLUSIONS: The present study highlights differences in HRQOL between specific sex/age strata and especially between people with and without a health condition in the general Spanish population. These factors must be considered when comparing general population HRQOL data with that of cancer patients.

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.

To What Extent Does Radiotherapy Improve the Quality of Life of Patients With Bone Metastasis?: A Prospective, Single-Institutional Study.

PURPOSE/OBJECTIVES: Radiation therapy (RT) is an effective method of palliating painful bone metastases and improves the quality of life (QoL) of these patients. The purpose of this trial is 2-fold: to quantify the impact of RT in the QoL of patients with bone metastasis and to compare the QoL results between the most used schemes of RT at our Centre. MATERIALS AND METHODS: A consecutive sample of patients with bone metastasis treated with RT in the Complejo Hospitalario de Navarra, Spain, was addressed between January 2011 and November 2012. The QoL was measured with the Quality of Life Questionnaire-C15-Palliative questionnaire, a short version of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-C30 for palliative care. Two assessments were proposed for each patient: one on the first day of the treatment and the other one a month after the end of the radiotherapy sessions. One hundred and sixteen patients completed the first questionnaire and 75 completed the second one (65%). RESULTS: Significant differences appeared in 9 domains, with better QoL in the second assessment. Five areas (physical functioning, global, fatigue, nausea, dyspnea, and constipation) showed little change (between 5 and 9 points), 3 (emotional functioning, insomnia, and appetite loss) showed moderate change (10 to 20 points), and 1 (pain) showed a very positive change (>30 points).When we compare the QoL scores between the 2 most used schemes of RT (30 Gy/10 fractions vs. 20 Gy/4 to 5 fractions), there are no significant differences in any QoL areas (and in 2 areas P was near 0.05). CONCLUSIONS: Palliative RT is a very active treatment for patients with bone metastasis regardless of age, location, primary tumor, or RT scheme. RT significantly improves the QoL, fundamentally by controlling pain and reducing analgesic use. Shorter schemes of RT produce at least-if not better-the same effect on QL than longer schemes (30 Gy).

Quality of life in long-term premenopausal early-stage breast cancer survivors from Spain. Effects of surgery and time since surgery.

PURPOSE: More research is needed into Quality of Life (QoL) in young early-stage breast cancer patients in the long-term. Knowledge of long-term effects of surgery on QoL in breast cancer patients is limited. The purpose of this study was to assess QoL in premenopausal Spanish early- stage breast cancer patients over a long follow-up period and evaluate differences among surgery-treated groups and the influence of time on patient QoL. METHODS: 243 premenopausal stage I-III relapse-free breast cancer patients completed the EORTC QLQ-C30 and QLQ-BR23 questionnaire once during follow-up (5-20 years after surgery). Univariate and multivariate logistic regression analyses were performed to estimate the results. RESULTS: QoL mean scores were high in most areas (>80 points in functioning: <20 points in symptoms areas). Limitations were moderate (>30 points) in global QoL, sleep disturbance, future perspective, sexual areas, and hot flashes. Mastectomized patients had a 4-fold greater risk of low scores in body image. Patients with a longer follow-up showed lower systemic side effects, hot flashes and breast symptoms. CONCLUSIONS: QoL in Spanish premenopausal early-stage breast cancer patients in a long follow-up after surgery is high. Differences in QoL among surgery-treated groups are limited. Time since surgery influences treatment side effects.

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.

Quality of life assessment by applying EORTC questionnaires to rectal cancer patients after surgery and neoadjuvant and adjuvant treatment.

BACKGROUND: Quality of Life (QoL) is a key element in rectal cancer (RC) patients. AIMS: this study assesses QoL in a sample of RC patients in their treatment follow-up period, and compares surgery modalities. PATIENTS AND METHODS: eighty four locally advanced RC patients who had received surgery and neoadjuvant chemoradiotherapy were included in the study. Of these, 70 had adjuvant chemotherapy. All patients completed the EORTC QLQ-C30 and the QLQ-CR29 once at least one year after completion of their treatment. Low anterior resection (LAR) patients also completed a Functional Evaluation questionnaire. RESULTS: QoL scores in the EORTC questionnaires for the sample as a whole were high in most dimensions, in line with the general population´s QoL values, although moderate limitations (> 30 points)were observed in urinary frequency, flatulence, impotence and sexual function. The scores for the Functional Evaluation were adequate (mean combined bowel function score of 18.2). LAR patients had a higher stool frequency than those with abdominoperineal resection (APR; p < 0.001). No differences in body image were found amongst LAR and APR patients. LAR patients with a lower anastomosis had higher faecal incontinence (p = 0.02), whereas those with a reservoir had better emotional functioning (p = 0.04) and higher faecal incontinence (p = 0.03). CONCLUSIONS: QoL scores and functional evaluation indicated patients had adapted to their disease and treatment. The few differences in QoL found between surgery modalities are in line with other recent studies and in contrast with earlier ones that suggested a lower QoL in APR patients.

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.

The EORTC cancer outpatient satisfaction with care questionnaire in ambulatory radiotherapy: EORTC OUT-PATSAT35 RT. Validation study for Spanish patients.

OBJECTIVES: The EORTC OUT-PATSAT35 RT questionnaire evaluates the satisfaction with care (SC) expressed by cancer outpatients treated with radiotherapy. In this study we assess the psychometric properties of the OUT-PATSAT35 RT when applied to a sample of Spanish patients. METHODS: A total of 100 patients with different tumor sites completed the EORTC core questionnaire, QLQ-C30, the OUT-PATSAT35 RT, the Oberst patients' perception of care quality and satisfaction scale (OS) and the item on intention to recommend the hospital (IR). Psychometric evaluation of the structure, reliability and validity of the questionnaire was conducted. RESULTS: Multitrait-scaling analysis showed that 33 out of 34 item-scale correlation coefficients met the standards for convergent validity and that many of them met the standards for discriminant validity. Cronbach's coefficients were good (0.70-0.97) for all scales except environment. Correlations between the areas of the QLQ-C30 and OUT-PATSAT35 RT were generally low (<0.40). Correlations between the OS and the IR were moderate with the EORTC OUT-PATSAT35 RT. Areas whose contents were more related had higher correlation coefficients (>0.50), and vice versa (<0.20). Patients with higher scores on the OS and the IR, patients who had more visits to the doctor and patients who had a better performance status showed higher SC levels in 12, 8 and 1 OUT-PATSAT35 RT areas, respectively. CONCLUSIONS: The OUT-PATSAT35 RT appears to be a reliable and valid instrument when applied to a sample of Spanish cancer patients. These results are in line with those of the validation study conducted by the authors of the questionnaire.

The EORTC cancer in-patient satisfaction with care questionnaire: EORTC IN-PATSAT32 Validation study for Spanish patients.

OBJECTIVES: The EORTC Quality of Life (QL) Group has developed a questionnaire (the EORTC IN-PATSAT32) to assess the satisfaction of cancer inpatients with hospitalbased care. In this study we assess the psychometric properties of the EORTC IN-PATSAT32 applied to a sample of Spanish patients. MATERIALS AND METHODS: Eighty cancer patients with different tumour sites completed the EORTC QLQ-C30 and EORTC IN-PATSAT32 questionnaires. Psychometric evaluation of the structure, reliability and validity was conducted. RESULTS: Multitrait scaling analysis showed that most itemscale correlation coefficients met the standards of convergent and discriminant validity. Cronbach's coefficients were good (0.77-0.97) for all scales except hospital access. Correlations between the scales and single items of the QLQ-C30 and EORTC IN-PATSAT32 were generally low. Correlations between the Oberst scales and an item on intention to recommend the hospital or ward to others with the EORTC IN-PATSAT32 were moderate. Patients with higher scores on the Oberst scales and the item on intention to recommend the hospital or ward showed higher satisfaction with care levels in all EORTC IN-PATSAT32 areas but one. CONCLUSIONS: The EORTC IN-PATSAT32 appears to be 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.