Associations between patient-reported late effects and systemic cytokines in long-term survivors of head and neck cancer treated with radiotherapy.

PURPOSE: Head and neck cancer (HNC) treatment may lead to late effects and impaired health-related quality of life of survivors. Knowledge on long-term late effects after radiotherapy (RT) and potential underlying biological mechanisms is lacking. We assessed the prevalence of xerostomia, dysphagia, and chronic fatigue (CF) in HNC survivors ≥ 5 years post-RT, and examined associations between pro-inflammatory cytokines and late effects. METHODS: In a cross-sectional study, 263 HNC survivors treated between 2007 and 2013 were enrolled. They completed validated questionnaires assessing xerostomia and dysphagia (the EORTC QLQ-H&N35), and CF (the Fatigue Questionnaire), and underwent blood sampling and clinical examination. Pro-inflammatory cytokines were analyzed in 262 survivors and 100 healthy age- and gender-matched controls. RESULTS: Median time since treatment was 8.5 years. The proportions of survivors reporting xerostomia, dysphagia, and CF were 58%, 31%, and 33%, respectively, with a preponderance of females. We found no significant associations between IL-6, IL-8, IP-10, TARC, TNF, or ENA-78 and the three late effects. The odds of having elevated levels of IL-6 and IP-10 were significantly higher in the survivors compared to the controls. CONCLUSIONS: More than one-third of long-term HNC survivors experienced xerostomia, dysphagia, and CF. Persistent inflammation, with elevated systemic cytokines, was not associated with these late effects, although HNC survivors had higher levels of some cytokines than the controls. IMPLICATIONS FOR CANCER SURVIVORS: This study provides new knowledge on late effects that can serve as grounds for informing patients with HNC about risk of late effects more than 5 years after RT.

Palliative interventions and prognosis in patients with advanced esophageal cancer.

In a retrospective review, in order to describe the palliative care and prognosis of patients with advanced cancer of the esophagus, the clinical characteristics and the treatment modalities applied were explored in relation to survival and symptom relief for 261 patients treated without curative potential. The data were obtained from a study of all patients with cancer of the esophagus treated at the Norwegian Radium Hospital in the 10-year period from 1990 to 1999. Medical data of the patients were reviewed and missing clinical information was retrieved from local hospitals and general practitioners. The patients were divided into three groups based upon the overall survival from start of treatment to death. Survival ≤3 months is in this paper, defined as 'short,' while survival > 6 months is defined as 'long.' Median survival for the total group of patients was 4 months. The 1-, 2-, and 3-year survival was 8%, 3%, and 1%, respectively. Patients with short survival (n= 107) had more advanced disease, lower performance status, and more dysphagia, weight loss, and pain and used more analgesics than patients with long survival (n= 91). Tumor characteristics such as localization, tumor length, and histology were not significantly associated with survival. This result was confirmed in a logistic regression analysis (with backward stepwise elimination) including sex, age, clinical stage, tumor length, tumor localization, histology, performance status, dysphagia, weight loss, and pain, where clinical stage, performance status, weight loss, and pain were included in the final model. A large variety of first-line palliative treatments were applied within the studied time period; external radiotherapy ± brachytherapy (n= 149), brachytherapy alone (n= 44), endoluminal stent (n= 28), laser evaporization (n= 8), chemotherapy (n= 5), and best supportive care only (n= 27). There were no clear differences in the effect on dysphagia between the modalities. Fourteen percent of the patients had treatment related complications. In conclusion, symptoms, performance status, and use of analgesics seemed to better prognosticate survival than tumor characteristics other than stage of disease. Our study reveals that knowledge about prognostic factors is crucial for the choice of palliative treatment. Even though all of the different treatment modalities seemed to provide relief of dysphagia, several other factors should be considered when deciding which treatment modality to offer. The time to onset of relief, duration of response, level of complications, and time spent in hospital should be a part of the decision-making process when selecting the appropriate treatment.

Characteristics and implications of attrition in health-related quality of life studies in palliative care.

In a longitudinal study of 297 palliative care patients, 280 patients were followed from inclusion to death. Characteristics and health-related quality of life (HRQL) of the participants and those who later dropped out were compared at inclusion, and 3 and 2 months before their death. At inclusion, the dropouts were older (P = 0.001), had reduced Karnofsky performance score (P < 0.001), received more help from the local authority (P = 0.004) and had reduced HRQL compared with patients who continued in the study and completed the next questionnaire. There were no differences in any of the HRQL parameters between participants and dropouts 3 months before death. Two months before death, differences in HRQL were found, but in favour of the dropouts. Data from patients close to death may be representative of a larger group of patients, whereas initial dropouts may lead to a positive bias of reported HRQL.

Test/retest study of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire.

PURPOSE: The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated instrument that assesses health-related quality of life (HRQOL) in cancer patients. It is used in cancer clinical trials in Europe, Canada, and the United States, and has demonstrated high reliability and validity in different groups of cancer patients. Despite thorough testing of reliability and validity, we have not identified any reports on its test/retest reliability; thus, a test/retest study was performed at the Norwegian Radium Hospital (NRH). MATERIALS AND METHODS: Cancer patients from the outpatient clinic who were off treatment for > or = 3 months were eligible for the study. The EORTC QLQ-C30 was given to the patients when they presented for their visit. The second questionnaire was received by the patients 4 days later. Of 291 eligible patients, 270 (93%) agreed to participate and 190 (73%) completed both questionnaires. RESULTS: The test/retest reliability measured by Pearson's correlation coefficient was high for all functional scales, with a range from .82 for cognitive and role function to .91 for physical function. The r value for global HRQOL was .85. For the symptom scales--nausea/vomiting, fatigue, and pain--the coefficients were .63, .83, and .86, respectively. The single-item coefficients ranged from .72 for diarrhea to .84 for financial impact. The Spearman rank correlation was in the same range for all dimensions. CONCLUSION: The EORTC QLQ-C30 seems to yield high test/retest reliability in patients with various cancer diagnoses whose condition is not expected to change during the time of measurement.

Health-related quality of life in the general Norwegian population assessed by the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire: the QLQ=C30 (+ 3).

PURPOSE: To obtain reference data on health-related quality of life (HRQOL) for the functional and symptom scales and single items of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ-C30 [+ 3]) in a representative sample of the Norwegian general population. PATIENTS AND METHODS: A randomly selected sample of 3,000 people from the Norwegian population, aged 18 to 93 years, who represent geographic diversity, took part in this postal survey. The EORTC QLQ-C30 (+ 3) and a questionnaire about demographic data and health were sent by mail. A new questionnaire package was sent as a reminder after 3 weeks. RESULTS: The survey yielded a high response rate with 1,965 of 2,892 eligible persons responding (68%). There was a low amount of missing data (1.8%). Internal consistency was highly satisfactory and yielded Cronbach's alpha coefficients greater than 0.70 for all but two functional scales and one symptom scale. The sensitivity of the questionnaire was shown by the excellent discrimination between age and sex groups. Clinical validity was shown by the distinct differences according to age and sociodemographic characteristics. Women reported lower functional status and global quality of life (mean scale scores from 71.7 to 91.0) than men (mean scale scores from 75.4 to 94.4), and also more symptoms and problems. This was remarkably consistent across age groups, as was a decline in functional status with an increase in age. CONCLUSION: This is the first study that presented reference data from the EORTC QLQ-C30 (+ 3) in a sample from a general population and seems to provide valid measures of HRQOL within different age groups. The results may serve as a guideline for clinicians when interpreting HRQOL in their own groups of patients, and contributes to a better understanding of the significance of mean scores and their clinical relevance.

Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35.

PURPOSE: The aim of this study was to define the scales and test the validity, reliability, and sensitivity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N35, a questionnaire designed to assess the quality of life of head and neck (H&N) cancer patients in conjunction with the general cancer-specific EORTC QLQ-C30. PATIENTS AND METHODS: Questionnaires were given to 500 H&N cancer patients from Norway, Sweden, and the Netherlands as part of two prospective studies. The patients completed the questionnaires before, during (Norway and Sweden only), and after treatment, yielding a total of 2070 completed questionnaires. RESULTS: The compliance rate was high, and the questionnaires were well accepted by the patients. Seven scales were constructed (pain, swallowing, senses, speech, social eating, social contact, sexuality). Scales and single items were sensitive to differences between patient subgroups with relation to site, stage, or performance status. Most scales and single items were sensitive to changes, with differences of various magnitudes according to the site in question. The internal consistency, as assessed by Cronbach's alpha coefficient, varied according to assessment point and within subsamples of patients. A low overall alpha value was found for the speech and the senses scales, but values were higher in assessments of patients with laryngeal cancer and in patients with nose, sinus, and salivary gland tumors. Scales and single items in the QLQ-H&N35 seem to be more sensitive to differences between groups and changes over time than do the scales and single items in the core questionnaire. CONCLUSION: The QLQ-H&N35, in conjunction with the QLQ-C30, provides a valuable tool for the assessment of health-related quality of life in clinical studies of H&N cancer patients before, during, and after treatment with radiotherapy, surgery, or chemotherapy.

Using reference data on quality of life--the importance of adjusting for age and gender, exemplified by the EORTC QLQ-C30 (+3).

Interpretation of health related quality of life (HRQOL) results in cancer patients is facilitated by knowledge of the levels of HRQOL in the general population. However, direct comparisons can be misleading unless age and gender are considered. We demonstrate the derivation of age- and gender-specific 'expected' values from population reference values by means of simple calculations. This survey included 3000 randomly selected Norwegians above 18 years of age who received the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 (+3) by mail. 1965 responses from 2,892 eligible persons (68%) were received. The population was divided into six disease groups based on self-reported health problems. The observed mean scale scores of the different groups deviated greatly from those obtained in the general population. The score for physical function, for example, was 72 for cancer patients and ranged from 73.3 to 82.5 in other disease groups, as opposed to 89.9 in the general population and 98.9 in those with no health problems. The range for one of the quality of life (QOL) scales was 57.7 to 84.7 compared with 73.7 in the general population. Expected mean scores for the patient groups were computed from the reference values, based on the concept of equivalence of age and gender. The differences between the observed mean scores and the reference values were strongly mediated by this method. The expected scores for physical function then ranged from 83.3 to 93.1 and from 70.3 to 75 for the QOL scale. The impact of age and gender on the reference data from the EORTC QLQ-C30 (+3) obtained in a general population shows that these variables must be considered when interpreting data on HRQOL for cancer patients. The demonstration of how to generate mean values which are adjusted according to the age and gender distribution of a population should increase the usefulness of this questionnaire among clinicians.

The EORTC core quality of life questionnaire (QLQ-C30): validity and reliability when analysed with patients treated with palliative radiotherapy.

The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. 247 patients completed the EORTC QLQ-C30 before palliative radiotherapy and 181 after palliative radiotherapy. The questionnaire was well accepted with a high completion rate in the present patient population consisting of advanced cancer patients with short life expectancy. In addition, the questionnaire was found to be useful to detect the effect of palliative radiotherapy over time. The scale reliability was excellent for all scales except the role functioning scale. Excellent criterion validity was found for the emotional functioning scale where it was correlated with GHQ-20. Performance of the questionnaire was improved after the second evaluation as compared with the first. The present study shows that the EORTC QLQ-C30 is found to be practical and valid in measuring quality of life in patients with advanced disease.

The development and utilisation of the European Organisation for research and treatment of cancer quality of life group item bank.

One of the problems in assessing patients' quality of life (QL) is the availability of good robust measures that have demonstrated validity, reliability and sensitivity for changes over time, but also have been validated across a large group of culturally diverse nations. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has recognised this and has established a substantial research programme with the aim of developing such tools, with particular relevance to cancer clinical trials. However, the management of a large set of items in multiple languages is difficult and very labour-intensive. Thus, to support the EORTC QLG research agenda, a computerised web-based database of all EORTC QLG measures and individual questionnaire items was developed. This database allows access to a pool of over 500 validated items in some 6000 translated versions. The database speeds up module development, ensures that questionnaires items have similar wording and provides rapid access to multiple translations.

Quality of life evaluation in oncological clinical trials - the EORTC model. The EORTC Quality of Life Study Group.

The European Organization for Research and Treatment of Cancer (EORTC) has taken a leading role in the development of the methodology of quality of life (QL) measurement. In the EORTC Quality of Life Study Group (QLSG) valid instruments to assess QL in a general manner and disease-specific modules have been developed to be used in oncological clinical trials. Statistical and methodological aspects of QL research are discussed. The application of QL assessments in clinical trials represents a subsequent challenge. To improve the practice of QL assessment in clinical trials an 'EORTC model' has been developed. This model requires the collaboration of liaison persons, the EORTC Cooperative Tumour Groups and the EORTC Data Centre Quality of Life Unit (QL Unit). Cooperation between these parties, protocol development and advantages and concerns of the model are mentioned in this paper. Finally, suggestions for improvement are proposed.

A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC Quality of Life Group.

This study tests the reliability and validity of the European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and version 3.0 of the EORTC Core Questionnaire (QLQ-C30) in 622 head and neck cancer patients from 12 countries. The patients completed the QLQ-C30, the QLQ-H&N35 and a debriefing questionnaire before antineoplastic treatment or at a follow-up. 232 patients receiving treatment completed a second questionnaire after treatment. Compliance was high and the questionnaire was well accepted by the patients. Multitrait scaling analysis confirmed the proposed scale structure of the QLQ-H&N35. The QLQ-H&N35 was responsive to differences between disease status, site and patients with different Karnofsky performance status, and to changes over time. The new physical functioning scale (with a four-point response format) of version 3.0 of the QLQ-C30 was shown to be more reliable than previous versions. Thus, the QLQ-H&N35, in conjunction with the QLQ-C30, appears to be reliable, valid and applicable to broad multicultural samples of head and neck cancer patients.

Quality of life in patients treated for head and neck cancer: a follow-up study 7 to 11 years after radiotherapy.

PURPOSE: To compare health-related quality of life factors in 845 head and neck cancer patients randomized to receive either conventional radiotherapy (2 Gy, 5 days-a-week) or a hypofractionated regimen (2.35 Gy, 4 days-a-week), a follow-up study was carried out 7 to 11 years after treatment in the surviving patients, representing 30% of the original patient number. METHODS AND MATERIALS: The cancer-specific EORTC Core Quality of Life Questionnaire (30 item version; the EORTC QLQ-C30) and a 19 item head and neck cancer-specific questionnaire were mailed to the 245 surviving patients of the trial. The EORTC QLQ-C30 is comprised of six multi-item function scales, three symptom scales, and six single items which assess both symptoms and economic consequences of the disease. Two hundred and four patients (83%) completed the questionnaire. The two groups of patients (N = 103 and N = 101) treated by different fractionating schedules, were comparable with regard to sociodemographic variables, tumor site, treatment variables (including different types of surgical treatment), and secondary primary cancers. Patients in the conventional group had more advanced disease and a higher recurrence rate compared to patients in the hypofractionated group. RESULTS: Unexpectedly, patients in the hypofractionated group, reported similar or better quality of life compared to patients in the conventional fractionated group. Patients in both groups described a high level of symptoms, like dryness in the mouth and mucus production. Clinical and sociodemographic variables did not explain variance in social function, emotional function or fatigue, except for the type of surgery performed, which significantly influenced the patients' emotional function. CONCLUSION: Long-term survivors of head and neck cancer reported a high level of disease and treatment related symptoms. Emotional function was significantly influenced by the type of surgical procedure. Strategies for future trials in head and neck cancer should continue to attempt to stress conservative surgical approaches and coordinated adjuvant therapy to maximize local regional control and quality of life. Functional and emotional outcome are important parameters which should prospectively be evaluated in future clinical trials in head and neck cancer.

A prospective study of quality of life in head and neck cancer patients. Part I: at diagnosis.

PURPOSE: A Swedish and Norwegian study was designed to examine health-related quality of life (HQL) in patients with head and neck cancer (head and neck) at diagnosis and during treatment and rehabilitation. The overall aim was to examine the impact on HQL at diagnosis depending on tumor location, stage, sex, and age (part I) and to describe HQL longitudinally and determine for which patients and during which period HQL deteriorated most (part II). This article presents the results at diagnosis. METHOD: Patients with head and neck cancer at five hospitals in Sweden and Norway were consecutively requested to participate. They were asked to answer the EORTC QLQ-C30 and QLQ-H&N35 (the European Organization for Research and Treatment of Cancer, Core 30 questionnaire and head and neck cancer module) repeatedly during 1 year. A total of 357 patients (mean age, 63 y; 72% males) were included. RESULTS: Patients with different tumor locations all had their special problems at diagnosis, for example, those with tumors in the larynx with communication, those with oral tumors with pain, and those with pharyngeal tumors with nutrition and pain. The patients with hypopharyngeal cancer reported the worst HQL. Stage appeared to have the strongest impact on HQL. Patients with a more advanced tumor stage reported significantly worse HQL scores for 24 of 32 variables reflecting functioning or problems. The females scored worse than the males for some areas, in particular, emotional functioning. The older patients scored significantly better for emotional and social functioning than patients <65 years but worse for physical functioning and various symptoms. The traditional way of grouping the tumor locations into oral, pharyngeal, laryngeal, and "other" tumors (salivary gland, sinus and nose, and unknown primary) was tested from a HQL point of view and found to be consistent. CONCLUSIONS: The chosen questionnaires differentiated between different sites of head and neck cancer at diagnosis. Tumor stage had the most powerful impact on HQL score.

A prospective study of quality of life in head and neck cancer patients. Part II: Longitudinal data.

OBJECTIVES: To evaluate the health-related quality of life (HRQL) of patients with head and neck cancer during and after treatment with radiotherapy, surgery, and chemotherapy. STUDY DESIGN: Prospective, descriptive study. METHODS: All new patients in four institutions in Norway and Sweden were asked to participate. Health-related quality of life was assessed at baseline and at 1, 2, 3, 6, and 12 months after start of treatment by means of the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire and the EORTC head and neck cancer-specific questionnaire. Baseline results are described elsewhere; longitudinal results are presented in the current article. Three hundred fifty-seven patients with cancer in the oral cavity, pharynx, larynx, nose, sinuses, and salivary glands and neck node metastases from unknown primaries filled in the questionnaires at baseline. RESULTS: Seventy-eight percent of the patients who were alive after 12 months filled in all questionnaires (218/280). The general trend was that HRQL deteriorated significantly during treatment, followed by a slow recovery until the 12-month follow-up with few exceptions (senses, dry mouth, and sexuality). Patients who later died reported worse HRQL at each assessment point compared with patients who filled in all six questionnaires, whereas those who dropped out of the study for other reasons were quite similar to patients who filled in all questionnaires. The patients with pharyngeal cancer in general reported worse HRQL compared with the other groups and did not reach pretreatment values in several domains. Stage was also an important factor for HRQL in patients with head and neck cancer. CONCLUSION: Detailed knowledge about the differences between groups and changes over time may aid us in the communication with patients and in the design of intervention studies focusing on improvement of the support and rehabilitation of patients with head and neck cancer.

Prospective, longitudinal quality-of-life study of patients with head and neck cancer: a feasibility study including the EORTC QLQ-C30.

Despite modern advances in the treatment of head and neck cancer, the survival rate fails to improve. Considering the different treatment modalities involved, quality of life has been thought of as an additional end point criterion for use in clinical trials. A Nordic protocol to measure the quality of life of head and neck cancer patients before, during, and after treatment was established. Before the study, a pilot study was done with this protocol. The main purpose of this pilot study was to find out whether this cancer population would answer quality-of-life questionnaires repeatedly (six times) over a 1-year period and whether the chosen questionnaires-a core questionnaire (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)), a tumor-specific questionnaire, and a psychological distress measure (Hospital Anxiety and Depression scale (HAD))-were sensitive for changes to functions and symptoms during the study year. The results presented in this article all refer to the pilot study. Forty-eight consecutive patients agreed to participate in the study. The most common tumor locations were the oral cavity (17) and the larynx (12). Almost all patients received combined treatment: 45 of 48 radiation therapy, 18 of 48 chemotherapy, and 17 of 48 surgery. After the primary treatment, 40 patients had complete tumor remission. Four of the 48 patients did not answer any questionnaires and were therefore excluded from the study. Of the remaining 44 patients, 3 died during the study year, and another 6 withdrew for various reasons. Thirty-five (85%) of the 41 patients alive at the 1-year follow-up answered all six questionnaires and thus completed the study. Mailed questionnaires were used throughout the study. All questionnaires were well accepted and found to be sensitive to changes during the study year. The greatest variability was found for symptoms and functions related specifically to head and neck cancer. The symptoms were swallowing difficulties, hoarse voice, sore mouth, dry mouth, and problems with taste. They all showed the same pattern, with an increase of symptoms during and just after finishing the treatment. The HAD scale revealed a high level of psychological distress, with 21% probable cases of psychiatric morbidity at diagnosis. In conclusion, it was shown that the study design and questionnaires were feasible for the forthcoming prospective quality-of-life assessment of Swedish and Norwegian head and neck cancer patients.

Influence from genetic variability on opioid use for cancer pain: a European genetic association study of 2294 cancer pain patients.

Cancer pain patients need variable opioid doses. Preclinical and clinical studies suggest that opioid efficacy is related to genetic variability. However, the studies have small samples, findings are not replicated, and several candidate genes have not been studied. Therefore, a study of genetic variability with opioid doses in a large population using a confirmatory validation population was warranted. We recruited 2294 adult European patients using a World Health Organization (WHO) step III opioid and analyzed single nucleotide polymorphisms (SNPs) in genes with a putative influence on opioid mechanisms. The patients' mean age was 62.5 years, and the average pain intensity was 3.5. The patients' primary opioids were morphine (n=830), oxycodone (n=446), fentanyl (n=699), or other opioids (n=234). Pain intensity, time on opioids, age, gender, performance status, and bone or CNS metastases predicted opioid dose and were included as covariates. The patients were randomly divided into 1 development sample and 1 validation sample. None of 112 SNPs in the 25 candidate genes OPRM1, OPRD1, OPRK1, ARRB2, GNAZ, HINT1, Stat6, ABCB1, COMT, HRH1, ADRA2A, MC1R, TACR1, GCH1, DRD2, DRD3, HTR3A, HTR3B, HTR2A, HTR3C, HTR3D, HTR3E, HTR1, or CNR1 showed significant associations with opioid dose in both the development and the validation analyzes. These findings do not support the use of pharmacogenetic analyses for the assessed SNPs to guide opioid treatment. The study also demonstrates the importance of validating findings obtained in genetic association studies to avoid reporting spurious associations as valid findings. To elicit knowledge about new genes that influence pain and the need for opioids, strategies other than the candidate gene approach is needed.

Quality of life in head and neck cancer patients after surgical resection: translation into Cantonese and validation of the EORTC QLQ-H&N35.

CONCLUSION: High convergent and discriminant validity between subscales was achieved after the translation of EORTC QLQ-H&N35 into Cantonese. Most subscales were assessing distinct components of quality of life (QoL). OBJECTIVES: The study aimed to translate the EORTC QLQ-H&N35 cancer module into Cantonese and to confirm validity and reliability for use in a Hong Kong head and neck (H&N) cancer population. SUBJECTS AND METHODS: An ethnocentric forward-backward translation of EORTC QLQ-H&N35 was conducted by bilingual head and neck health professionals. Discrepancies were identified and problematic wording and concepts revised. Further review preceded pilot testing in 119 postoperative H&N cancer patients. Internal consistency within each subscale, convergent and discriminant validity to check the item relevance and item representativeness within and between subscales were examined. Mean and standard deviations of each subscale and single item and Cronbach's alpha coefficients for subscales were calculated. RESULTS: Six of seven subscales achieved standard reliability (Cronbach's alpha coefficient >0.7). Correlation coefficients between an item and its own subscale were significantly higher than the coefficients with other subscales. Scaling success was found in all subscales. Pearson's correlation coefficient between subscales was <0.70, except between the subscales swallowing and trouble with social eating (r = 0.795), and speech problems and social contact (r = 0.754).

Psychological distress in head and neck cancer patients 7-11 years after curative treatment.

Long-term survivors of head and neck cancer may suffer from psychological distress and reduced quality of life because of late side-effects of the treatment. In a follow-up study of patients randomised to two different radiation fractionating regimens, 204 patients filled in a mailed questionnaire 7-11 years after treatment. The questionnaire consisted of the General Health Questionnaire, 20-item version (GHQ-20), and the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30). There were no differences in psychological distress between patients receiving conventional radiotherapy and those receiving a slightly hypofractionated regimen. A high prevalence of psychological distress was found in both treatment groups (30% of 'cases' according to the GHQ-20), especially in patients with impaired cognitive or social function, or with pain. Clinicians need to be aware of this morbidity, and their ability to detect patients with psychological problems needs to be improved. The GHQ-20 can facilitate the communication process in a clinical setting. With an increased awareness of these problems and by using valid instruments for identification of patients at risk, the clinicians may intervene and help the patients to reduce their psychological distress.

Psychometric validation of the EORTC Core Quality of Life Questionnaire, 30-item version and a diagnosis-specific module for head and neck cancer patients.

A cancer-specific self-reporting quality of life questionnaire has been validated. The questionnaire is designed to assess physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning, pain, fatigue, emesis and quality of life by means of multi-item scales, and other disease- and treatment-related symptoms by means of single items. The questionnaire was completed by 126 head and neck cancer patients with a mean age of 67 years. The internal consistency (scale reliability) was satisfactory for all scales but one. Correlations between scales and items assessing the same underlying dimension were also satisfactory. The questionnaire discriminates between patient subgroups and between acute, subacute and late toxicity. Patient compliance was high. The questionnaire provided valuable information, and most of the scales/items functioned well. A few problems were found, especially with the modified visual analogue scales, and minor modifications will be made.