The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and ...health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used.
We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors.
We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment.
Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.
Objective
Bioelectrical impedance analysis (BIA) is used to measure the patient’s body composition, fat-free mass, phase angle (PA), and standardized phase angle (SPA), which are affected by ...malnutrition. Low values of PA and SPA have been found to be negative prognostic factors for survival in different types of cancer and other severe diseases. The aim of the current study was to investigate whether PA and SPA can be used to predict survival in head and neck (HN) cancer.
Methods
One hundred twenty-eight patients with advanced HN cancer treated in Western Sweden 2002–2006 were examined with BIA at diagnosis, and PA and SPA were calculated. Patients’ age, gender, tumor site, TNM stage, and performance status were obtained, and weight, height, and BIA were measured. Survival up to 12 years was ascertained.
Results
The mean PA was 5.85° and the median was 5.91°. Lower PA and SPA values were significantly associated with shorter overall survival in univariate analyses, together with higher age, oral cancer, higher T class, worse performance status, more weight loss before diagnosis, lower: weight, height, BMI, and reactance. Age, performance status, T class, and PA were significant factors for the overall survival in the multivariable analysis. A PA cutoff value at 5.95° provided the best prediction of 5-year survival.
Conclusions
PA and SPA at diagnosis are significant factors for survival in patients with advanced HN cancer. They are promising prognostic tools to use in treatment planning; further studies are needed.
Purpose
The purpose of this study was to investigate the impact of the type of data capture on the time and help needed for collecting patient-reported outcomes as well as on the proportion of ...missing scores.
Methods
In a multinational prospective study, thyroid cancer patients from 17 countries completed a validated questionnaire measuring quality of life. Electronic data capture was compared to the paper-based approach using multivariate logistic regression.
Results
A total of 437 patients were included, of whom 13% used electronic data capture. The relation between data capture and time needed was modified by the emotional functioning of the patients. Those with clinical impairments in that respect needed more time to complete the questionnaire when they used electronic data capture compared to paper and pencil (OR
adj
24.0;
p
= 0.006). This was not the case when patients had sub-threshold emotional problems (OR
adj
1.9;
p
= 0.48). The odds of having the researcher reading the questions out (instead of the patient doing this themselves) (OR
adj
0.1;
p
= 0.01) and of needing any help (OR
adj
0.1;
p
= 0.01) were lower when electronic data capture was used. The proportion of missing scores was equivalent in both groups (OR
adj
0.4,
p
= 0.42).
Conclusions
The advantages of electronic data capture, such as real-time assessment and fewer data entry errors, may come at the price of more time required for data collection when the patients have mental health problems. As this is not uncommon in thyroid cancer, researchers need to choose the type of data capture wisely for their particular research question.
This study aimed at developing a shortened version of the EORTC QLQ-C30, one of the most widely used health-related quality of life questionnaires in oncology, for palliative care research. The study ...included interviews with 41 patients and 66 health care professionals in palliative care to determine the appropriateness, relevance and importance of the various domains of the QLQ-C30. Item response theory methods were used to shorten scales. Patients and health care professionals rated pain, physical function, emotional function, fatigue, global health status/quality of life, nausea/vomiting, appetite, dyspnoea, constipation, and sleep as most important. Therefore, these scales/items were retained in the questionnaire. Four scales were shortened without reducing measurement precision. Important dimensions not covered by the questionnaire were identified. The resulting 15-item EORTC QLQ-C15-PAL is a ‘core questionnaire’ for palliative care. Depending on the research questions, it may be supplemented by additional items, modules or questionnaires.
Purpose The EORTC QLQ-H&N35 (H&N35) is widely used to measure quality of life in head and neck cancer patients. The aims of this study were to obtain insight into a) the languages in which the H&N35 ...has been used and the psychometric properties in those languages, b) the study designs, and c) its acceptance by patients and investigators. Methods A systematic literature review was performed searching for all original papers that had used at least one item of the H&N35. Identified papers were read and the information about methodological issues abstracted statistically analysed. Results A total of 136 papers were identified. The H&H35 was administered in 19 different languages in 27 countries. The study design was cross-sectional in the majority of studies (53 %), prospective cohort studies (31 %), phase-II-trials (7 %), phase-III-trials (6 %) and case–control studies (1 %). The scales with the highest percentages of missing values were Sexuality (11.5 %) and Speech (7 %). The median Cronbach’s alpha of the multiitem scales ranged from 0.61 (Senses) to 0.93 (Sexuality). Construct validity was rarely investigated. On average, 12 scales (range 0-18) of the instrument were used by the investigators. The scale most often used was swallowing (in 85 % of studies) and least often used was Weight Gain (39 %). Conclusion The H&N35 is widely used throughout the world, mainly in observational studies, and has demonstrated robust psychometric features in different languages. However, some methodological problems reported imply that the instrument can be improved in some areas.
Background
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed computerised adaptive tests (CATs) for the 14 functional and symptom ...domains of the EORTC QLQ-C30 quality of life questionnaire. This is expected to optimise measurement precision, relevance to patients and flexibility. Here, we present the first international validation of the EORTC CAT Core.
Methods
A heterogeneous sample of 699 cancer patients scheduled for chemotherapy and/or radiotherapy was recruited across seven European countries. The EORTC CAT Core and all QLQ-C30 items were administered to participants before and after initiating treatment. Correlations between CAT and QLQ-C30 scores and floor/ceiling effects were calculated. Using several grouping variables, relative validity (cross-sectional known groups difference), responsiveness (changes over time) and relative sample size requirements of the CAT compared to the QLQ-C30 were estimated.
Results
Correlations of the CAT and QLQ-C30 ranged from 0.81 to 0.93 across domains. The mean relative reduction in floor and ceiling effects using the CAT was 42% (range 3–99%). Analyses of known groups validity and responsiveness indicated that, across domains, mean sample size requirements for the CAT were 72% and 70%, respectively, of those using the QLQ-C30.
Conclusions
The EORTC CAT Core measures the same domains as the QLQ-C30 with reduced floor/ceiling effects. The CAT generally facilitated the use of smaller samples (about 30% smaller on average) without loss of power compared to the QLQ-C30. Based on this study, the EORTC QLG will release the EORTC CAT Core for general use.
Abstract Objective The purpose of this study was to prospectively and longitudinally compare the health-related quality of life (HRQOL) outcomes between head and neck (HN) cancer patients treated ...with parotid-sparing intensity modulated radiation therapy (IMRT) and patients treated with 3-dimensional conventional radiation therapy (3D-CRT). Methods and materials Before and up to 12 months after treatment, HRQOL was recorded in patients with HN cancer who were referred to the Department of Oncology at Sahlgrenska University Hospital for curative IMRT. The study group's HRQOL was compared with a matched group of patients from previous descriptive HRQOL studies treated with 3D-CRT. Both groups' HRQOL was measured by the European Organization for Research and Treatment for Cancer QLQ-C30 and European Organization for Research and Treatment for Cancer QLQ-HN35 at 6 time points in the first year after diagnosis. Results Two hundred and seven patients were included, 111 treated with IMRT and 96 matched controls treated with 3D-CRT. Both groups' HRQOL deteriorated during and after treatment. Just after treatment, worse HRQOL scores were observed in the IMRT group regarding insomnia (38 vs 27; P = .032), appetite loss (64 vs 50; P = .019), senses (54 vs 41; P = .017), and coughing (39 vs 26, P = .009). At 12 months, however, significantly better HRQOL scores were observed in the IMRT group regarding problems with dry mouth (72 vs 62; P = .018), pain (28 vs 20; P = .018), sexuality (37 vs 23; P = .016), social contacts (10 vs 6; P = .026), cognitive functioning (79 vs 87; P = .0057), and financial difficulties (12 vs 20; P = .0019). Conclusions This study further supports the hypothesis that the introduction of IMRT has improved the long-term quality of life of HN cancer patients who have been treated with radiation therapy, but might cause more acute side effects. Longer follow-up is needed to study late complications.
AbstractPurposeKnowledge of long-term health-related quality of life (HRQOL) in patients with advanced head and neck cancer treated with intensity modulated radiation therapy is scarce. Methods and ...MaterialsHRQOL in 126 patients with advanced head and neck cancer treated with intensity modulated radiation therapy was followed longitudinally from diagnosis to 5 years after treatment with the European Organization for Research and Treatment of Cancer's QLQ-C30, the European Organization for Research and Treatment of Cancer's Head and Neck Cancer Module, and the M.D. Anderson Dysphagia Inventory. The survivors' HRQOL was compared with an age- and sex-matched normal population cohort. ResultsAt 5 years, 73 of the 95 surviving patients had completed the study. Significant reductions in general pain (29 vs 12), head and neck (HN) pain (22 vs 14), and feeling ill (20 vs 10) were found, and emotional functioning (70 vs 83) and global quality of life (67 vs 74) improved, compared with baseline values. Conversely, dry mouth (19 vs 56), senses (8 vs 27), teeth problems (10 vs 22), opening mouth (19 vs 56), and sticky saliva (15 vs 40) were markedly worse, although significant improvements had occurred over time after treatment. Anderson Dysphagia Inventory scores >80 at 5 years indicated good swallowing function. In a subgroup analysis, dry mouth and senses were significantly better in patients treated with chemoradiotherapy. Comparison to a normal population cohort's HRQOL shows that the study group experienced a wide array of symptoms affecting their quality of life. ConclusionsThe results of this large, long-term follow-up study show that a majority of patients report a reasonable quality of life 5 years after treatment and that there seems to be continuous improvement over time. Comparison with a normal population cohort, however, underlines the fact that classical side effects remain, even with improved radiation techniques. Additional emphasis on normal-tissue-sparing radiation therapy is warranted, with close attention devoted to HRQOL outcomes.
Objectives: Assessment of health‐related quality of life (HRQL) in head and neck cancer patients from diagnosis to 5 years after start of treatment.
Study Design: A prospective, descriptive study
...Methods: three hundred fifty‐seven patients from Norway and Sweden filled in HRQL questionnaires, the European Organisation for Research and Treatment of Cancer (EORTC) QLQ–C30 and the EORTC QLQ‐H&N35, six times during the first year and then after 5 years. At 5 years, 167 (87%) of the 192 living patients filled in questionnaires.
Results: Group data: clinical significant improvements in HRQL were not found between 1 and 5 years. Problems with teeth, opening of the mouth, dryness in the mouth, and sticky saliva were persistent or worsening. Similar findings were found regardless of sex, age, stage, or site when clinical significant changes are considered. Patients who died between 1 and 5 years reported reduced HRQL on 15 of 28 scales at 1 year compared with the survivors. Individual data: 40% of patients reported improved global HRQL from diagnosis to 5 years after start of treatment. In addition, 11% had “top scores” at both assessment points. The pattern in global HRQL scores also applies for most of the other function and symptom scales.
Conclusion: After the first year after treatment, recovery of the persisting side effects of treatment cannot be expected for the group as a whole. Patients must be prepared for this. Some individual patients experience improvement in global HRQL. HRQL assessments in daily clinical practice can identify patients who are in need of additional support and symptom relief.
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