Effects of a Training Intervention for Enhancing Recovery after Ivor-Lewis Esophagus Surgery: A Randomized Controlled Trial.

BACKGROUND AND AIMS: There is a risk of decreased physical function, quality of life and persistent pain after open surgery for esophageal cancer. There are currently no studies that evaluate the effect of any postoperative intervention, including physical exercises, after this type of surgery. The aim of the study was therefore to evaluate the effect of a training intervention after Ivor-Lewis resection of the esophagus. MATERIAL AND METHODS: Patients scheduled for esophagus resection according to Ivor-Lewis were randomized to an intervention group or a control group. The training intervention started at discharge and lasted three months. Before discharge, patients were given three leaflets with exercises to increase range of motion in the affected area and exercises aiming to restore lung function and physical function. All exercises were described in detail and the patients carried out the ones in the first program under supervision. Before surgery and three months after discharge, the patients estimated their level of physical function, level of physical activity, and quality of life. They also underwent spirometry, measurements of range of motion in the rib cage, spine, and shoulders, and three functional tests. Comparisons of differences within and between the groups were made. RESULTS: A total of 43 of 64 randomized patients participated in the follow-up. Postoperatively, the patients in the intervention group had a significantly higher degree of physical function and less deteriorated range of motion in right shoulder flexion and thoracic left lateral flexion. There were no significant differences between the groups in lung function, pain, or quality of life. CONCLUSION: The results of the three-month intervention indicate that specific training can positively affect physical function and range of motion to preoperative values. The intervention was well tolerated, and no side effects were registered.

International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer.

BACKGROUND: Older people represent the majority of cancer patients but their specific needs are often ignored in the development of health-related quality of life (HRQOL) instruments. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-ELD15 was developed to supplement the EORTC's core questionnaire, the QLQ-C30, for measuring HRQOL in patients aged >70 years in oncology studies. METHODS: Patients (n=518) from 10 countries completed the QLQ-C30, QLQ-ELD15 and a debriefing interview. Eighty two clinically stable patients repeated the questionnaires 1 week later (test-retest analysis) and 107 others, with an expected change in clinical status, repeated the questionnaires 3 months later (response to change analysis, RCA). RESULTS: Information from the debriefing interview, factor analysis and item response theory analysis resulted in the removal of one item (QLQ-ELD15QLQ-ELD14) and revision of the proposed scale structure to five scales (mobility, worries about others, future worries, maintaining purpose and illness burden) and two single items (joint stiffness and family support). Convergent validity was good. In known-group comparisons, the QLQ-ELD14 differentiated between patients with different disease stage, treatment intention, number of comorbidities, performance status and geriatric screening scores. Test-retest and RCA analyses were equivocal. CONCLUSION: The QLQ-ELD14 is a validated HRQOL questionnaire for cancer patients aged 70 years. Changes in elderly patients' self-reported HRQOL may be related to both cancer evolution and non-clinical events.

Energy intake and sources of nutritional support in patients with head and neck cancer--a randomised longitudinal study.

BACKGROUND/OBJECTIVES: Malnutrition decreases the cancer patient's ability to manage treatment, affects quality of life and survival, and is common among head and neck (HN) cancer patients due to the tumour location and the treatment received. In this study, advanced HN cancer patients were included and followed during 2 years in order to measure their energy intake, choice of energy sources and to assess problems with dysphagia. The main purpose was to explore when and for how long the patients had dysphagia and lost weight due to insufficient intake and if having a PEG (percutaneous endoscopic gastrostomy) in place for enteral nutrition made a difference. SUBJECTS/METHODS: One hundred thirty-four patients were included and randomised to either a prophylactic PEG for early enteral feeding or nutritional care according to clinical praxis. At seven time points weight, dysphagia and energy intake (assessed as oral, nutritional supplements, enteral and parenteral) were measured. RESULTS: Both groups lost weight the first six months due to insufficient energy intake and used enteral nutrition as their main intake source; no significant differences between groups were found. Problems with dysphagia were vast during the 6 months. At the 6-, 12- and 24-month follow-ups both groups reached estimated energy requirements and weight loss ceased. Oral intake was the major energy source after 1 year. CONCLUSIONS: HN cancer patients need nutritional support and enteral feeding for a long time period during and after treatment due to insufficient energy intake. A prophylactic PEG did not significantly improve the enteral intake probably due to treatment side effects.

Combined stent insertion and single high-dose brachytherapy in patients with advanced esophageal cancer--results of a prospective safety study.

Previous randomized studies comparing the two commonly used palliative treatments for incurable esophageal cancer, i.e. stent insertion and intraluminal brachytherapy, have revealed the pros and cons of each therapy. While stent treatment offers a more prompt effect, brachytherapy results in more long-lasting relief of dysphagia and a better health-related quality of life (HRQL) in those living longer. This prospective pilot study aimed to explore the feasibility and safety of combining these two regimes and incorporating a single high dose of internal radiation. Patients with newly diagnosed, incurable cancer of the esophagus and dysphagia were eligible for inclusion, and stent insertion followed by a single dose (12 Gy) of brachytherapy was performed as a two-stage procedure. Clinical parameters including HRQL and adverse events were registered at inclusion, and 1, 2, 3, 6, and 12 months later. Twelve patients (nine males) with a median age of 73 years (range 54-85) were included. Stent insertion followed by a single dose of brachytherapy was successfully performed in all but one patient who was treated with stent only. Relief of dysphagia was achieved in the majority of cases (10/11, P < 0.05), but HRQL did not improve except for dysphagia-related items. Only minor adverse events, including chest pain, reflux, and restenosis, were reported. The median survival time after inclusion was 6.6 months. Our conclusion is that the combination of stent insertion and single high-dose brachytherapy seems to be a feasible and safe palliative regime in patients with advanced esophageal cancer. Randomized trials comparing the efficacy of this strategy to stent insertion or brachytherapy alone are warranted.

Factors predicting survival in patients with advanced oesophageal cancer: a prospective multicentre evaluation.

BACKGROUND: Oesophageal cancer is often diagnosed at an advanced stage, with poor prognosis and severe morbidity. In majority of cases, palliative treatment is the only option available. AIM: To find factors that can predict survival for patients with incurable cancer of the oesophagus or gastro-oesophageal junction and hence aid in the choice of treatment. METHODS: Ninety-six patients were included. Health-related quality of life questionnaires (EORTC QLQ C-30 and QLQ OES18) were administered and computerized tomography-derived size assessment of the primary tumours was performed. Univariate and multivariate Cox-regression analyses were used to determine potential predictors of survival. RESULTS: Karnofsky Index, occurrence of metastases (M-stage), Union International Contre le Cancer-stage, computerized tomography-derived tumour size assessment and 10 of 25 scales and single items from the health-related quality of life questionnaires were found to be related to survival. In the multivariate analysis, three of the health-related quality of life questionnaire scales (physical functioning, fatigue and reflux) were found to add prognostic information to M-stage, the single strongest predictor (HR 1.9, P < 0.01). CONCLUSION: In addition to M-stage, the outcome of health-related quality of life questionnaires can sharpen the prediction of survival in patients with advanced cancer of the oesophagus or gastro-oesophageal junction and thus aid in the choice of palliative treatment strategy.

Psychiatric morbidity among patients with cancer of the esophagus or the gastro-esophageal junction: a prospective, longitudinal evaluation.

Cancer of the esophagus is often diagnosed at a late stage and is related to severe morbidity and a low 5-year survival rate. Previous studies have reported low health-related quality of life and high suicide rates for these patients. The occurrence of psychiatric morbidity and thus the potential need for psychological support may vary over time after diagnosis. This has not been adequately studied in patients with newly diagnosed cancer of the esophagus or gastro-esophageal junction. The present study therefore aimed to prospectively evaluate the prevalence of psychiatric morbidity in 94 consecutive patients (median age 66, range 45-88 years) with all stages of disease. Psychiatric morbidity was evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire at inclusion and 1, 2, 3, 6 and 12 months later. At inclusion, 42% of the patients had HADS scores indicating possible or probable anxiety disorder and/or depression. At all follow-ups except at 3 months, proportions of patients with possible/probable anxiety disorder were significantly lower than at inclusion. Among patients with a duration of tumor-specific symptoms exceeding 6 months pre-diagnosis, larger proportions of patients with a possible/probable anxiety disorder were found at the 1- and 6-month follow ups. The prevalence of possible/probable depression was greater among patients treated with a palliative intent than among those with a curative intent at inclusion. Patients who died during the study period scored worse for depression compared to the survivors. Apart from this, the proportion of patients with possible/probable psychiatric morbidity (anxiety and/or depression) was relatively stable over time and was unrelated to patient characteristics or clinical background, including the treatment regime. In conclusion, psychiatric morbidity is common among esophageal cancer patients, both at inclusion and over time, regardless of the cancer therapy given. The findings stress the importance of monitoring the patients' mental health and of offering adequate psychological care when needed.

Determinants of patient satisfaction in oncology settings from European and Asian countries: preliminary results based on the EORTC IN-PATSAT32 questionnaire.

The aim of this study was to identify factors associated significantly with hospitalised cancer patients' satisfaction with care. Patients were recruited from four geographical/cultural groups, including five European countries and Taiwan. They rated their level of satisfaction by completing the EORTC IN-PATSAT32 questionnaire at home. Additionally, data were collected on the sociodemographic and clinical characteristics and the quality of life of the patients, as well as on institutional characteristics. Of 762 patients recruited, 647 (85%) returned a completed questionnaire. The number of nurses and doctors per bed, institution size, geo-cultural origin, ward setting, teaching/non-teaching setting, treatment toxicity, global health status, participation in clinical trials and education level were all associated significantly at the multivariate level with satisfaction with doctor and nurse interpersonal skills, information provision, availability, and/or overall satisfaction. A number of patient-, institutional- and culture-related factors are associated with the perceived quality of cancer care. Future studies, with appropriate sampling frames and stratification procedures, are needed to better understand cross-national and cross-cultural differences in cancer patient satisfaction.

An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32).

Little is known about patients' satisfaction with care in oncology hospitals across cultural contexts. Within the EORTC, we developed a 32-item satisfaction with care questionnaire to measure patients' appraisal of hospital doctors and nurses, as well as aspects of care organisation and services. This study assessed the psychometric characteristics of the questionnaire, the EORTC IN-PATSAT32, in a large, international sample of patients with cancer. Patients discharged from a surgery or medical oncology ward in nine countries were invited to complete at home the EORTC IN-PATSAT32 as well as other instruments for psychometric testing. Of 762 eligible patients recruited, 15% failed to return the questionnaire. Of the 647 compliant patients, 63% completed the questionnaires within 15 min and 82% required no help in its completion. Multitrait scaling analysis revealed excellent internal consistency and convergent validity, although some scales within the IN-PATSAT32 were relatively highly correlated. Test-retest data on 113 patients showed high reliability for most scales. Scales of the IN-PATSAT32 and of the QLQ-C30 were not significantly correlated, suggesting that the two questionnaires are assessing quite distinct concepts. The scales of the IN-PATSAT32 were able to discriminate clearly between patients with differing care expectations and differing intentions to recommend their hospital to others. This study supports the acceptability to patients, and the psychometric robustness of the EORTC IN-PATSAT32 questionnaire. Further studies are needed to assess the responsiveness of the questionnaire to changes in the structure and process of care over time.

Stent insertion or endoluminal brachytherapy as palliation of patients with advanced cancer of the esophagus and gastroesophageal junction. Results of a randomized, controlled clinical trial.

SUMMARY: Esophageal cancer often presents as advanced stage disease with a dismal prognosis, with only 10-15% of patients surviving 5 years. Therefore, in a large proportion of patients, palliative treatment is the only option available. The aim of this study was to prospectively compare the palliative effect of self-expandable stent placement with that of endoluminal brachytherapy regarding the effect on quality of life and on specific symptoms. Sixty-five patients with advanced cancer of the esophagus or gastroesophageal junction were randomized to treatment with either an Ultraflex expandable stent or high-dose-rate endoluminal brachytherapy with 7 Gy x 3 given in 2-4 weeks. Clinical assessment and health-related quality of life (HRQL) were measured at inclusion and 1, 3, 6, 9 and 12 months later. The HRQL was measured with standardized questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal Module and Hospital Anxiety and Depression Scale). Twenty-eight patients completed the stent treatment and 24 patients the brachytherapy. The group of patients treated with stent reported significantly better HRQL scores for dysphagia (P < 0.05) at the 1-month follow-up, but most other HRQL scores, including functioning and symptom scales, deteriorated. Among brachytherapy-treated patients, improvement was found for the dysphagia-related scores at the 3-months follow-up, whereas other significant changes of scores were few. The median survival time was comparable in the two groups (around 120 days). In conclusion, insertion of self-expandable metal stents offered a more instant relief of dysphagia compared to endoluminal brachytherapy, but HRQL was more stable in the brachytherapy group.

Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer.

Quality of life (QOL) assessment requires clinically relevant questionnaires that yield accurate data. This study defined measurement properties and the clinical validity of the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess QOL in oesophageal cancer. The oesophageal module the QLQ-OES24 and core questionnaire, the Quality of Life-Core 30 questionnaire (QLQ-C30) was administered patients undergoing treatment with curative (n=267) or palliative intent (n=224) and second assessments performed 3 months or 3 weeks later respectively. Psychometric tests examined scales and measurement properties of the module. Questionnaires were well accepted, compliance rates were high and less than 2% of items had missing data. Multi-trait scaling analyses and face validity refined the module to four scales and six single items (QLQ-OES18). Selective scales distinguished between clinically distinct groups of patients and demonstrated treatment-induced changes over time. The EORTC QLQ-OES18 demonstrates good psychometric and clinical validity. It is recommended for use with the core questionnaire, the QLQ-C30, to assess QOL in patients with oesophageal cancer.

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.

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.

Health-related quality of life three years after diagnosis of head and neck cancer--a longitudinal study.

PURPOSE: To examine health-related quality of life (HRQL) of all head and neck cancer patients from diagnosis until 3 years later and to analyze its dependence on tumor site and other patient characteristics. SUBJECTS AND METHODS: Two hundred thirty-two patients (mean age 61 years; 70% men) were included and followed with clinical measures and mailed standardized HRQL questionnaires (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30), the EORTC QLQ-Head and Neck Cancer module (QLQ-H&N35), and the Hospital Anxiety and Depression Scale (HADS). RESULTS: After 3 years 66% of the patients were alive and 88% of these completed the study. The HRQL was worse during treatment and returned slowly thereafter to pretreatment values with few exceptions. After 3 years the best improvement was found for mental distress, followed by a significant global quality of life improvement and reduced pain compared with diagnosis. A significant deterioration was found for problems with dry mouth, senses, and teeth, as well as for opening the mouth wide (ie, they seemed to be related to the treatment given). There were few significant improvements between the 1- and 3-year follow-ups. Depression and physical functioning at diagnosis were independent predictors for global quality of life at 3 years. Patients who died during the study had a worse HRQL at diagnosis compared with patients completing the study. Patients with advanced disease (stage III + IV) scored worse than patients with small tumors for most of the HRQL domains. These differences increased over time. Few differences were found relating to gender and age. The pharyngeal cancer group scored worse compared with the other tumor sites, and these patients would probably benefit from a rehabilitation program right from diagnosis, including treatment for malnutrition and pain. CONCLUSIONS: The largest HRQL changes for head and neck cancer patients are seen within the first year after diagnosis, with a significant deterioration just after finishing treatment. Thereafter, most of the variables return to pretreatment values. The significant problems with dry mouth, senses, and teeth after treatment are constant over time.

Health-related quality of life in long-term head and neck cancer survivors: a comparison with general population norms.

To examine the health-related quality of life (HRQL) in long-term head and neck (H&N) cancer survivors compared with general population norms. HRQL was assessed with three standardized questionnaires: the SF-36 Health Survey (Short Form 36) and the EORTC QLQ-C30 and QLQ-H&N35 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, -Core 30 and -Head and Neck 35 cancer module). Altogether 135 H&N cancer patients (mean age 62 years, 31% females) of 151 survivors (89% acceptance) from a longitudinal HRQL study (n = 232) were included 3 years after diagnosis. The H&N cancer patients' SF-36 scores did not differ significantly from those of an age- and sex-matched sample (n = 871) from the Swedish normative population, except on the role-physical functioning scale. On the other hand, treatment-related side-effects and disease-specific problems (e.g., swallowing, local pain and dry mouth) measured by the H&N cancer module were, with few exceptions, significantly worse than norm values. Gender comparisons revealed that female H&N cancer patients generally scored better than the norms on both the SF-36 and the EORTC QLQ-C30, while the male patients scored significantly worse on most SF-36 scales. Patients > or =65 years more often scored worse than the norm than did patients <65. Clinically relevant differences were found on the majority of SF-36 scales in comparison of tumour sites, however, comparisons of patients with small (stage I+II) versus advanced (stage III+IV) tumours revealed few differences. Three years after diagnosis H&N cancer patients still suffer significant functional limitations/problems related to their disease and its treatment but these problems do not generally affect their overall HRQL. Tumour stage no longer differentiates HRQL at 3 years, however, factors related to the patients' age, gender and location of the tumour appear to have bearing on their reported health status.

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.

Long-term study of quality and safety of osseointegration for the retention of auricular prostheses.

The aim of this article is to describe the safety and quality of the osseointegrated implant technique for the retention of craniofacial prostheses, to present a protocol for collection of clinical data, and to discuss the impact of the procedure on the patient quality of life. A protocol was designed and used to study patients who had received auricular prostheses consecutively since 1979 at our department. The patients were asked to answer a questionnaire designed to describe symptoms and problems specific for someone wearing an auricular prosthesis. In total, 99 patients received 107 prosthetic ears (8 patients had bilateral defects) retained on 309 implants (2 to 4 implants/ear). Patients of all ages were represented, and only 9 discontinuities were reported. Most patients (95%) wear their prosthesis every day, in most cases more than 10 hours/day. The follow-up period ranged from 1 to 12 years, giving a total of 2624 postoperative observations of implants, with a 3% incidence of significant skin reaction. We conclude that the surgical technique for auricular prostheses retained on osseointegrated implants is simple and associated with a low rate of peroperative and long-term complications. It offers a high degree of stability and aesthetic satisfaction.

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

A 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 effects of psychosocial intervention in patients with head and neck cancer.

METHODS: Two studies of psychosocial interventions in head and neck cancer patients at different stages of their disease were performed. We explored the feasibility and effectiveness of different approaches, offered for the first time to this population. The first study concerned long-term group psychological therapy for patients with newly diagnosed head and neck cancer. Quality of life was measured longitudinally for 1 year and compared with that of a control group. The second study comprised a short-term psychoeducational program 1 year after treatment for head and neck cancer. Quality-of-life assessments were made repeatedly from diagnosis until 1 month after the intervention. RESULTS: Thirteen patients started the psychological group therapy, and 8 of them completed both the intervention and evaluation procedure. The quality of life of the therapy group improved more than that of a control group in most areas measured during the study year, in particular psychiatric morbidity, social functioning, emotional functioning, and global quality of life. The results indicate benefits from the therapy, although the therapy group scored worse than the control group at diagnosis. Most of the variables representing functioning and symptoms improved after the 1-week psychoeducational program, especially items reflecting "trouble eating" and "problems enjoying your meals." Patients' judgments of the intervention quality indicated satisfaction with all separate elements, mostly education, about cancer and the opportunity to socialize with the other guests. CONCLUSION: These pilot studies suggest that head and neck cancer patients can benefit from different psychosocial interventions. Quality-of-life questionnaires were well accepted and sensitive to changes during the studies. Thus our early findings seem promising and would justify confirmation in larger studies.

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.

Quality of life and voice in patients with laryngeal carcinoma: a posttreatment comparison of laryngectomy (salvage surgery) versus radiotherapy.

OBJECTIVES: This study was designed to compare the voice and the quality of life (QOL) of laryngeal cancer patients receiving treatment with radical radiotherapy with or without laryngectomy as salvage surgery. We also compared the patients' own perceptual ratings of their voice to the perceptual ratings of a group of listeners. STUDY DESIGN: Two groups of laryngeal cancer patients were studied. METHODS: Fourteen irradiated laryngeal speakers with preserved larynx were matched with 14 salvage surgery laryngectomized patients speaking with tracheoesophageal prosthesis (TEP). To measure patients' QOL, we used the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), the EORTC Head and Neck module (EORTC QLQ-H&N35), the Hospital Anxiety and Depression scale (HAD) and a study-specific questionnaire. For the perceptual speech evaluation we used visual analog scales. RESULTS: The perceptual ratings of speech intelligibility, voice quality, and speech acceptability showed a significant difference between the treatment groups. Both the patients who received treatment with radiotherapy and the listeners rated the irradiated laryngeal voices higher than the tracheoesophageal speech. The laryngectomized patients scored significantly better than the patients treated with radical radiotherapy on the question about hoarseness. No other significant difference was found for the QOL functions and symptoms. CONCLUSION: When patients treated with radiotherapy were compared with patients treated with laryngectomy as salvage surgery, QOL was similar, only small differences being found in the perceptual speech evaluation.