Marianne Ahlner-Elmqvist

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 Cronbachs 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.

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

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.

Development of a European Organization for Research and Treatment of Cancer (Eortc) Questionnaire Module to be Used in Quality of Life Assessments in Head and Neck Cancer Patients

A head and neck cancer specific questionnaire module designed to be used in quality of life assessments before, during, and after radiotherapy and surgery, with or without combinations with chemotherapy has been developed in accordance with guidelines given by the EORTC Quality of Life Study Group. Relevant issues were generated by means of literature search, and interviews with specialists and patients. Pre-testing of a preliminary questionnaire module was performed in patients from Norway, Sweden, Denmark, United Kingdom and French-speaking Belgium. The resulting head and neck cancer module, the EORTC QLQ-H&N37, includes 37 items concerning disease and treatment related symptoms, social function and sexuality. By using a combination of the general EORTC QLQ-C30 and the EORTC QLQ-H&N37, health-related quality of life measurements may be compared between studies in different cancer populations, and still be sensitive to changes in the target population.

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.

A palliative-care intervention and death at home: a cluster randomised trial.

BACKGROUND The Palliative Medicine Unit at University Hospital of Trondheim, Norway, started an intervention programme that aims to enable patients to spend more time at home and die there if they prefer. Close cooperation was needed with the community health-care professionals, who acted as the principal formal caregivers, and a multidisciplinary consultant team coordinated the care. We did a cluster randomised trial to assess the interventions effectiveness compared with conventional care METHODS Community health-care districts in and around Trondheim, Norway, were defined as the clusters to be randomised. We enrolled 434 patients (235 assigned intervention and 199 conventional care [controls]) in these districts who had incurable malignant disease and an expected survival of 2-9 months. Main outcomes were place of death and time spent in institutions in the last month of life. FINDINGS 395 patients died. Of these, more intervention patients than controls died at home (54 [25%] vs 26 [15%], p<0.05). The time spent at home was not significantly increased, although intervention patients spent a smaller proportion of time in nursing homes in the last month of life than did controls (7.2 vs 14.6%, p<0.05). Hospital use was similar in the two groups. INTERPRETATION The palliative-care intervention enabled more patients to die at home. More resources for care in the home (palliative care training and staff) and an increased focus on use of nursing homes would be necessary, however, to increase time at home and reduce hospital admissions.

A prospective multicentre study in Sweden and Norway of mental distress and psychiatric morbidity in head and neck cancer patients

SummaryA Swedish/Norwegian head and neck cancer study was designed to assess prospectively the levels of mental distress and psychiatric morbidity in a heterogeneous sample of newly diagnosed head and neck cancer patients. A total of 357 patients were included. The mean age was 63 years, and 72% were males. The patients were asked to answer the HAD scale (the Hospital Anxiety and Depression scale) six times during 1 year. The number of possible or probable cases of anxiety or depression disorder was calculated according to standardized cut-offs. Approximately one-third of the patients scored as a possible or probable case of a major mood disorder at each measurement point during the study year. There were new cases of anxiety or depression at each time point. The anxiety level was highest at diagnosis, while depression was most common during treatment. Females were more anxious than males at diagnosis, and patients under 65 years of age scored higher than those over 65. Patients with lower performance status and more advanced disease reported higher levels of mental distress and more often scored as a probable or possible cases of psychiatric disorder. Our psychometric analyses supported the two-dimensional structure and stability of the HAD scale. The HAD scale seems to be the method of choice for getting valid information about the probability of mood disorder in head and neck cancer populations. The prevalence of psychiatric morbidity found in this study emphasizes the importance of improved diagnosis and treatment.

Quality of Life and Head and Neck Cancer: A 5 Year Prospective Study.

Objectives: Assessment of health‐related quality of life (HRQL) in head and neck cancer patients from diagnosis to 5 years after start of treatment.

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.

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.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-pf-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.

Quality of life in advanced cancer patients: the impact of sociodemographic and medical characteristics

Population-based surveys have shown that health-related quality of life (HRQL) is influenced by patients’ characteristics such as age, gender, living situation and diagnoses. The present study explores the impact of such factors on the HRQL of severely ill cancer patients. The study sample included 395 cancer patients who participated in a cluster randomised trial of palliative care. Median survival was 13 weeks. HRQL assessments (using the EORTC QLQ-C30 questionnaire) were compared among subgroups of relevant patients’ characteristics (ANOVA), and the significance of individual covariates was explored by multivariate linear regression. Most EORTC QLQ-C30 scores showed minor differences between genders. Higher age was associated with less sleeping disturbance, less pain and better emotional functioning. No positive impact of living with a partner was found. Performance status and/or time from assessment to death were significantly associated with most functioning and symptom scores. We concluded that although the overall impact of sociodemographic characteristics may seem less important to HRQL scores among advanced cancer patients than in general populations, age and gender should be allowed for. Performance status and closeness to death also need to be reported.