European Organization For Research And Treatment Of Cancer QLQ-H Research Articles

Left-Right Differences in Oral Function and Quality of Life of Patients Who Underwent Tongue Resection.

Background The tongue plays an important role in oral functions, including articulation, eating, and swallowing. The treatment of tongue cancer (TC) often leads to oral morbidities, such as limited mouth opening, dry mouth, swallowing difficulties, and mucositis. The anterior-posterior resection area of the tongue has a significant impact on oral function and quality of life (QOL). However, the specific left-right differences in oral function of patients who underwent tongue resection remain unclear. This study aimed to investigate the effect of left-right differences on oral function and QOL in patients with TC who underwent tongue resection. Methodology This study included 40 patients with TC who underwent surgical resection smaller than hemiglossectomy and were divided into left (LG) and right (RG) tongue groups. The oral, respiratory, and feeding functions and the QOL at baseline (before treatment) and one, three, and six months after treatment (1M, 3M, and 6M, respectively) were evaluated. Maximum tongue pressure and lip-closure force were used to evaluate the oral functions. Peak expiratory flow was used to evaluate the respiratory function. The Functional Oral Intake Scale was used to evaluate the feeding functions. The QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QOL Questionnaires: QLQ-C30, QLQ-H&N35. Results The results indicated that there were no significant differences in oral, respiratory, or feeding function between the LG and RG groups at all evaluation periods. However, regarding QOL assessments, at 3M, LG indicated a significantly higher score than RG for swallowing (LG = 3.17, RG = 10.00, p = 0.037) and trouble with social eating (LG = 12.30, RG = 20.56, p = 0.025) in the EORTC QLQ-H&N35. At 6M, the LG also indicated a significantly higher QOL than RG for global health status (LG = 81.14, RG = 65.69, p = 0.018) and physical function (LG = 96.51, RG = 89.80, p = 0.047) in the EORTC QLQ-C30. Conclusions While the left-right differences in tongue function did not lead to functional impairment post-surgery, they significantly affected the QOL. The results indicate the importance of considering these differences in postoperative care to effectively address the QOL concerns.

Effect of yoga therapy on psychological distress and quality of life in head-and-neck cancer patients undergoing radiotherapy

Context: Significant psychological morbidity with stress, depression, and anxiety has been reported in head-and-neck cancer (HNC) patients undergoing curative treatment. Failure to detect and treat psychological distress affects the outcomes of cancer therapies and decreases patients' quality of life (QoL). Studies have reported the benefits of yoga for anxiety, symptom severity, and distress in cancer patients. Aims: To identify the effects of yoga therapy on psychological distress and QoL in HNC patients undergoing radiotherapy. Settings and Design: Single-group, pretest posttest study in a clinical setting. Subjects and Methods: Psycho-Oncology Assessment Questionnaire, Distress Thermometer, European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0, and EORTC QLQ-H&N35 questionnaires were administered to HNC patients (n = 22) before and after yoga intervention during 6 weeks of radiotherapy. The yoga intervention included loosening practices, asana, pranayama, and meditation. Statistical Analysis: Data were analyzed in statistical software - STATA, version 10.1 (2011). Results: Significant reduction in psychological distress (p = 0.0001) and improvement in the QoL (p = 0.0001) was observed. Significant improvement in physical, emotional, cognitive, social, and role functioning (p = 0.0001) was observed. Significant reduction in QLQ-C30 symptom subscale scores of insomnia, pain, appetite loss, and fatigue (p = 0.0001) was observed. Significant reduction in H&N35 symptom subscale scores related to swallowing, opening the mouth (p = 0.0001), trouble with social eating, trouble with social contact, and felt ill (p < 0.05) was observed. Conclusion: Yoga therapy intervention significantly reduced the psychological distress, improved the QoL, improved functions, and reduced symptoms in HNC patients undergoing radiotherapy. Further validation is required by conducting randomized controlled trials with a larger sample size.

Exploring quality of life among head-and-neck cancer patients in Western India using European organization for research and treatment of cancer questionnaires.

Head-and-neck cancers (HNCs) are one of the major public health problems for both patients and the health-care providers in India. The clinical manifestations of HNC and its treatment can lead to negative effects on the quality of life (QoL) of the patient. The study is aimed to explore the QoL using the European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaires among HNC patients in Western part of India. A cross-sectional prospective study was conducted among 400 HNC patients attending the tertiary cancer center. The QoL was assessed by using the EORTC core questionnaire (EORTC QLQ-C30) and EORTC head- and neck-specific questionnaire (EORTC QLQ-H and N35). The data were explored using means, standard deviation, medians, ranges, and proportions. All the 400 patients had completed the questionnaire having a compliance rate of 100%. There was no missing data at the item level for the EORTC QLQ-C30 questionnaire. While the missing items for EORTC QLQ-H and N35 were: problems while swallowing food, problems with teeth, and sexuality. The mean functional score ranged from 74.22 to 93.49 for EORTC QLQ-C30. The mean symptoms score was found in the range from 3.25 to 81.50 for EORTC QLQ-H and N35. Both questionnaires were comprehensive and well accepted by the patients. These questionnaires provided the information-related disease-specific QoL data, which otherwise is often missed. Health-care providers should not only focus on the clinical effects of treatment but also on QoL issues because it will improve overall patient care and survival.

Durability of the parotid-sparing effect of intensity-modulated radiotherapy (IMRT) in early stage nasopharyngeal carcinoma: A 15-year follow-up of a randomized prospective study of IMRT versus two-dimensional radiotherapy.

The durability of improved xerostomia with intensity-modulated radiotherapy (IMRT) in patients with early stage nasopharyngeal carcinoma (NPC) is uncertain. We conducted a long-term prospective assessment of participants treated with IMRT or two-dimensional radiotherapy (2DRT) in a prior randomized study. Parent study participants (IMRT, n = 28; 2DRT, n = 28) who were free of second malignancy or recurrence were eligible. Long-term radiotherapy-related toxicities were graded according to the Radiation Therapy Oncology Group (RTOG) criteria. Long-term patient-reported outcomes were assessed by the six-item xerostomia (XQ) and two European Organisation for Research and Treatment of Cancer (EORTC) questionnaires (QLQ-C30, QLQ-H&N35). Overall survival (OS), locoregional relapse-free survival (LRFS), distant relapse-free survival (DRFS), and the rate of symptomatic late complications (SLCs) were estimated for the entire cohort (n = 56). Totally, 21 (IMRT, n = 10; 2DRT, n = 11) patients gave consent and were assessed for an overall median follow-up of 15.5 years. There was significantly less RTOG ≥grade 2 xerostomia with IMRT versus 2DRT (20% vs. 90%; p = 0.001), but no significant difference in XQ scores. Patients in the IMRT arm reported lower mean scores for the "dry mouth" domain of EORTC QLQ-H&N35 (p = 0.02) and showed trends toward better 15-year OS (81.5% vs. 53.8%, p = 0.06), LRFS (70.6% vs. 53.8%, p = 0.38), and DRFS (81.5% vs. 53.8%, p = 0.07). SLCs were more frequent in the 2DRT arm. The parotid-sparing effect of IMRT in NPC treatment is durable, with significantly less physician- and patient-scored xerostomia at 15 years. IMRT results in better long-term survival and fewer SLCs.

Marathi Translation and Linguistic Validation of an Updated European Organization for Research and Treatment of Cancer Quality of Life Module for Head and Neck.

Aim This study was aimed to translate an updated European Organization for Research and Treatment of Cancer (EORTC) quality of life module for head and neck (EORTC QLQ-H&N43) in grammatically and conceptually acceptable Marathi language and its linguistic validation. Materials and Methods Approval was obtained from the Institutional Ethics Committee. The permission for translation was obtained from the EORTC translation unit (TU). The EORTC guidelines for the translation were followed to form a translation for pilot testing which was administered to 10 Marathi speaking head and neck squamous cell cancer (HNSCC) patients who gave informed written consent for the participation in the study. Patients were interviewed personally. The final Marathi translation was prepared and sent to EORTC TU for approval. Statistical analysis was performed using SYSTAT version 12 by Cranes software, Bengaluru, Karnataka, India. Results After getting permission, the translation files were received from EORTC TU, including Marathi EORTC QLQ-H&N35 for reference. Two forward translations, reconciled translation, back translations, first interim translation, translation for proof editing, and second interim translation (SIT) were prepared. This SIT was pilot tested in 10 Marathi-speaking HNSCC patients. Each patient was interviewed regarding difficulty in answering, confusing or offensive word, and reframing sentence. The questionnaire was well understood by patients reflecting its linguistic validity. After incorporating the changes as per the patient’s interview, updated translation was prepared and sent to EORTC TU which was accepted and approved by EORTC. The psychometric analysis of pilot testing showed that the questionnaire is acceptable. Conclusion Marathi translation of EORTC QLQ-H&N43 is well accepted and understandable. It can be used for future studies.

Resilience and quality of life (QoL) of head and neck cancer and brain tumour survivors in Pakistan: an analytical cross-sectional study protocol

BackgroundCancer is a devastating disease and has detrimental effects on the quality of life (QoL) of cancer survivors and interferes with their treatment compliance. The aim of the study is...

Nivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial

Patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck have few treatment options and poor prognosis. Nivolumab significantly improved survival of this patient population when compared with standard single-agent therapy of investigator's choice in Checkmate 141; here we report the effect of nivolumab on patient-reported outcomes (PROs). CheckMate 141 was a randomised, open-label, phase 3 trial in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who progressed within 6 months after platinum-based chemotherapy. Patients were randomly assigned (2:1) to nivolumab 3 mg/kg every 2 weeks (n=240) or investigator's choice (n=121) of methotrexate (40-60 mg/m2 of body surface area), docetaxel (30-40 mg/m2), or cetuximab (250 mg/m2 after a loading dose of 400 mg/m2) until disease progression, intolerable toxicity, or withdrawal of consent. On Jan 26, 2016, the independent data monitoring committee reviewed the data at the planned interim analysis and declared overall survival superiority for nivolumab over investigator's choice therapy (primary endpoint; described previously). The protocol was amended to allow patients in the investigator's choice group to cross over to nivolumab. All patients not on active therapy are being followed for survival. As an exploratory endpoint, PROs were assessed at baseline, week 9, and every 6 weeks thereafter using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30), the EORTC head and neck cancer-specific module (EORTC QLQ-H&N35), and the three-level European Quality of Life-5 Dimensions (EQ-5D) questionnaire. Differences within and between treatment groups in PROs were analysed by ANCOVA among patients with baseline and at least one other assessment. All randomised patients were included in the time to clinically meaningful deterioration analyses. Median time to clinically meaningful deterioration was analysed by Kaplan-Meier methods. CheckMate 141 was registered with ClinicalTrials.org, number NCT02105636. Patients were enrolled between May 29, 2014, and July 31, 2015, and subsequently 361 patients were randomly assigned to receive nivolumab (n=240) or investigator's choice (n=121). Among them, 129 patients (93 in the nivolumab group and 36 in the investigator's choice group) completed any of the PRO questionnaires at baseline and at least one other assessment. Treatment with nivolumab resulted in adjusted mean changes from baseline to week 15 ranging from -2·1 to 5·4 across functional and symptom domains measured by the EORTC QLQ-C30, with no domains indicating clinically meaningful deterioration. By contrast, eight (53%) of the 15 domains in the investigator's choice group showed clinically meaningful deterioration (10 points or more) at week 15 (change from baseline range, -24·5 to 2·4). Similarly, on the EORTC QLQ-H&N35, clinically meaningful worsening at week 15 was seen in no domains in the nivolumab group and eight (44%) of 18 domains in the investigator's choice group. Patients in the nivolumab group had a clinically meaningful improvement (according to a difference of 7 points or greater) in adjusted mean change from baseline to week 15 on the EQ-5D visual analogue scale, in contrast to a clinically meaningful deterioration in the investigator's choice group (7·3 vs -7·8). Differences between groups were significant and clinically meaningful at weeks 9 and 15 in favour of nivolumab for role functioning, social functioning, fatigue, dyspnoea, and appetite loss on the EORTC QLQ-C30 and pain and sensory problems on the EORTC QLQ-H&N35. Median time to deterioration was significantly longer with nivolumab versus investigator's choice for 13 (37%) of 35 domains assessed across the three questionnaires. In this exploratory analysis of CheckMate 141, nivolumab stabilised symptoms and functioning from baseline to weeks 9 and 15, whereas investigator's choice led to clinically meaningful deterioration. Nivolumab delayed time to deterioration of patient-reported quality-of-life outcomes compared with single-agent therapy of investigator's choice in patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck. In view of the major unmet need in this population and the importance of maintaining or improving quality of life for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, these data support nivolumab as a new standard-of-care option in this setting. Bristol-Myers Squibb.

Assessing the Comparability of Paper and Electronic Versions of the EORTC QOL Module for Head and Neck Cancer: A Qualitative Study.

BackgroundPatient-reported outcome (PRO) instruments are important tools for monitoring disease activity and response to treatment in clinical trials and clinical practice. In recent years, there have been movements away from traditional pen-and-paper PROs towards electronic administration. When using electronic PROs (ePROs), evidence that respondents complete ePROs in a similar way to their paper counterparts provides assurance that the two modes of administration are comparable or equivalent. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 item (EORTC QLQ-C30) and associated disease-specific modules are among the most widely used PROs in oncology. Although studies have evaluated the comparability and equivalence of electronic and original paper versions of the EORTC QLQ-C30, no such studies have been conducted to date for the head and neck cancer specific module (EORTC QLQ-H&N35).ObjectiveThis study aimed to qualitatively assess the comparability of paper and electronic versions of the EORTC QLQ-H&N35.MethodsTen head and neck cancer patients in the United States underwent structured cognitive debriefing and usability interviews. An open randomized crossover design was used in which participants completed the two modes of administration allocated in a randomized order. Using a “think-aloud” process, participants were asked to speak their thoughts aloud while completing the EORTC QLQ-H&N35. They were thoroughly debriefed on their responses to determine consistency in interpretation and cognitive process when completing the instrument in both paper and electronic format.ResultsParticipants reported that the EORTC QLQ-H&N35 demonstrated excellent qualitative comparability between modes of administration. The proportion of noncomparable responses (ie, where the thought process used by participants for selecting responses appeared to be different) observed in the study was low (11/350 response pairs [35 items x 10 participants]; 3.1%). Evidence of noncomparability was observed for 9 of the 35 items of the EORTC QLQ-H&N35 and in no more than 2 participants per item. In addition, there were no apparent differences in level of comparability between individual participants or between modes of administration.ConclusionsMode of administration does not affect participants’ response to, or interpretation of, items in the EORTC QLQ-H&N35. The findings from this study add to the existing evidence supporting the use of electronic versions of the EORTC instruments when migrated to electronic platforms according to best practice guidelines.

Identifying Predictors of Extracapsular Extension (ECE) in Patients Considering Primary Surgery for Human Papillomavirus–Associated Oropharyngeal Squamous Cell Carcinoma (OPSCC)

145; Table 1 Percentage of patients with extracapsular extension by size and number of involved nodes. Raw numbers in parentheses. No. of involved nodes Lymph node size 2.0 cm 2.1-3.0 cm 3.1-4.0 cm >4.0 cm 1 20.0 (1/5) 9.1 (1/11) 18.8 (3/16) 0 (0/10) 2 40.0 (2/5) 54.5 (6/11) 36.4 (4/11) 66.7 (6/9) Volume 94 Number 4 2016 Posters 889 We used the following questionnaires: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (general QOL), EORTC H&N-35 (head and neckespecific QOL), EAT-10 (swallowing), and NDII (neck dissection impairment index). We compared post-CRT and post-ND composite and itemized scores using 2-tailed t tests. Results: Thirty-eight enrolled patients had a neck dissection, performed at a median of 9 weeks post-CRT. Pretreatment N stage was 10 N1/N2a, 23 N2b, and 5 N2c. Median number of levels dissected was 2 (range, 1-6) and median number of nodes dissected was 12 (range, 1-46). Five patients had bilateral ND. Median time from ND to postoperative assessment was 2 months (range, 1-7 months) for acute and 18 months (range, 8-37 months) for late timepoints. There was a significant worsening of the neck dissection impairment index (NDII) score from post-CRT to acute (87.4 vs 80.2, PZ.023) but not late (PZ.558) post-ND timepoints. The acute decrease in the NDII was greater in patients with >12 nodes dissected (PZ.007) and was overall correlated with the total number of nodes dissected (Spearman PZ.027). Overall EORTC-QLQ-C30, H&N-35, and EAT-10 scores did not worsen post-ND. Conclusion: The use of post-CRT selective neck dissection did not worsen general (EORTC QLQ-C30), head and neckespecific (EORTC QLQ-H&N 35), or swallowing (EAT-10) QOL scores. An instrument designed to assess the specific impact of neck dissection (NDII) on QOL did show a significant decrease in acute, but not late NDII QOL score after neck dissection with a greater acute decrement associated with a higher number of dissected nodes. Author Disclosure: K. Wang: None. R.J. Amdur: None. W.M. Mendenhall: None. R. Green: None. S. Aumer: None. T. Hackman: None. A. Zanation: None. J.P. Zevallos: None. S. Patel: None. M. Weissler: None. B.S. Chera: None.

Longterm quality of life after oncologic surgery and microvascular free flap reconstruction in patients with oral squamous cell carcinoma

BackgroundQuality of life (QoL) has become increasingly important in cancer treatment. It refers to the patient’s perception of the effects of the disease and therapy, and their impact on daily functioning and general feeling of well being.Material and Methodsn this prospective study, a total of 100 patients treated at our institution, completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire and the specific EORTC QLQ-H&N35 module. The questionnaires were distributed to the patients between 12 and 60 months postoperatively.ResultsGlobal QoL score was 58.3 and mean score for functioning scale was 76.7. Fatigue (28.7 ± 26.1), followed by financial problems (27.7 ± 33.5), insomnia (26.7 ± 34.5) and pain (26.3 ± 29.9) had highest symptom score on QLQ-C30. Fatigue (r=-0.488), insomnia (r=-0.416) and pain (r =-0.448) showed highest value for significantly negative correlation to global QoL. In the H&N35 module, restriction of mouth opening (43.3 ± 38.6), dry mouth (40.7 ± 36.9), sticky saliva (37.3 ± 37.1) and eating in public (33.8 ± 31.9) were the four worst symptoms. Swallowing problem (r=-0.438), eating in public (r=-0.420) and persistent severe speech (r=-0.398) ranked as the three worst symptoms with highest value for significantly negative correlation to global QoL.ConclusionsLongterm QoL after oncologic surgery and microvascular free flap reconstruction in patients with oral cancer is satisfactory. Measuring QoL should be considered as part of the evaluation of cancer treatment. Key words:Longterm quality of life, oral cancer, oncologic surgery, microvascular free flap reconstruction.

Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial.

Patients treated for head and neck carcinomas experience a significant deterioration of their quality of life during treatments because of severe side effects. Nabilone has many properties that could alleviate symptoms caused by radiotherapy and improve patients' quality of life. The aim of the present study was to compare the effects of nabilone versus placebo on the quality of life and side effects during radiotherapy for head and neck carcinomas. Fifty-six patients were randomized to nabilone or placebo. Patients filled the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H&N35; three independent questionnaires assessing appetite, nausea, and toxicity; and a visual analog scale for pain. These data were collected before radiotherapy, each week during radiotherapy, and 4 weeks after radiotherapy. Patients were weighed every week. Nabilone did not lengthen the time necessary for a 15% deterioration of quality of life (P = .4279), and it was not better than placebo for relieving symptoms like pain (P = .6048), nausea (P = .7105), loss of appetite (P = .3295), weight (P = .1454), mood (P = .3214), and sleep (P = .4438). At the dosage used, nabilone was not potent enough to improve the patients' quality of life over placebo.

Quality of life in patients after resection of pT3 lateral tongue carcinoma: Microvascular reconstruction versus primary closure.

Controversy exists regarding the functional advantages of free flap reconstruction after partial glossectomy as compared to primary closure. Forty patients were included in this retrospective analysis after resection of pT3 lateral tongue carcinomas. Twenty patients received a free forearm flap and 20 patients had a primary closure. All patients had adjuvant chemoradiation, were free of disease at least 1 year after therapy, and completed the German versions of the European Organization for Research and Treatment of Cancer (EORTC) questionnaires Quality of Life Questionnaire-Core 30-questions (QLQ-C30) and Quality of Life Questionnaire-Core 30 Head and Neck 35-questions (QLQ-H&N35). Mean time between surgery and quality of life (QOL) assessment was 16.2 ± 3.4 months. The average resection was 41.60% (reconstruction) of the oral tongue, and 39.1% (primary closure). After reconstruction, patients had significantly (p > .05) fewer problems with the swallowing, speech, and social eating subdomains of the EORTC QLQ-H&N35. All other items showed no significant differences. Our preliminary results suggest that free flaps might be useful when treating pT3 tongue cancer.

Differences in quality of life in obese and normal weight head and neck cancer patients undergoing radiation therapy.

The aim of this study was to evaluate health-related quality of life (HRQOL) in patients with different body mass indices (BMI, <25 vs ≥25) undergoing radiation treatment for head and neck cancer. HRQOL was examined by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H&N35, in the beginning and in the end of radiation treatment in 60 patients treated at University Hospital in Northern Norway. Information about nutritional status with weight loss, hemoglobin level (Hb), serum albumin, and a study-specific questionnaire also was filled out in the beginning and in the end of treatment. The patients' general condition, skin, and mucous membranes (CTCAE v.3.0) (grades 1 to 5 with unique clinical descriptions) were documented four times during radiation treatment. Changes in HRQOL were calculated and compared by paired sample t test. Multiple regression analyses were used to examine correlations between baseline BMI and changes in HRQOL, CTCAE v.3.0 toxicity, nutritional status, and information that radiotherapists provided to patients. Patients with BMI ≥ 25 had less mucosal changes after 2 weeks of radiation treatment than patients with BMI < 25 (p = 0.010). Differences regarding feeding tube use (p = 0.037) and intake of nutritional supplements before radiation treatment (p = 0.001) were also seen. Patients with overweight had more dyspnea (p = 0.033) before treatment and more problems with dry mouth (p = 0.042) after treatment. During treatment, patients with BMI ≥ 25 had more problems with opening mouth (p = 0.034) than patients with BMI < 25 and more changes in sexuality (p = 0.019). Patients with BMI ≥ 25 received less information about food and drink (p = 0.011) in the radiation treatment period than normal weight patients. BMI influences HRQOL and toxicity. Additional longitudinal studies should examine whether or not overweight patients persistently experience more problems with dry mouth and opening their mouth. Regardless of BMI, all patients should be informed about nutritional recommendations during treatment.

Assessment of radiation-induced xerostomia: validation of the Italian version of the xerostomia questionnaire in head and neck cancer patients.

Xerostomia is the most common acute and late side effect of radiation treatment for head and neck cancer. Affecting taste perception, chewing, swallowing and speech, xerostomia is also the major cause of decreased quality of life. The aims of this study were to validate the Italian translation of the self-reported eight-item xerostomia questionnaire (XQ) and determine its psychometric properties in patients treated with radiotherapy for head and neck cancer. An observational cross-sectional study was conducted in the Radiotherapy Unit of the Veneto Institute of Oncology - IOV in Padua. The XQ was translated according to international guidelines and filled out by 102 patients. Construct validity was assessed using principal component analysis, internal consistency using Cronbach's α coefficient and test-retest reliability at 1-month interval using the intraclass correlation coefficient (ICC). Criterion-related validity was evaluated to compare the Italian version of XQ with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality-of-Life Questionnaire (QLQ-C30) and its Head and Neck Cancer Module (QLQ-H&N35). Cronbach's α for the Italian version of XQ was strong at α = 0.93, test-retest reliability was also strong (0.79) and factor analysis confirmed that the questionnaire was one-dimensional. Criterion-related validity was excellent with high association with the EORTC QLQ-H&N35 xerostomia and sticky saliva scales. The Italian version of XQ has excellent psychometric properties and can be used to evaluate the impact of emerging radiation delivery techniques aiming at preventing xerostomia.

Changes in health related quality of life in women and men undergoing radiation treatment for head and neck cancer and the impact of smoking status in the radiation treatment period

PurposeThe aim of this study was to evaluate health-related quality of life (HRQOL) in women and men undergoing radiation treatment for head and neck cancer through the intervention period and examine if age, body mass index (BMI) and smoking status at baseline may modify changes in HRQOL. MethodsHRQOL was examined by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H&N35, in the beginning and end of the treatment period in 65 patients at the University Hospital in Northern Norway. Changes in HRQOL were calculated and compared by paired sample T-tests. Linear multiple regression analyses were used to examine if baseline characteristics had any influence towards HRQOL changes. ResultsMost aspects of HRQOL declined substantially and significantly (p < 0.001) with a magnitude of more than one standard deviation during the radiation treatment period irrespective of sex and age. Smoking status at baseline had some, albeit minor, influence on changes in HRQOL. Patients who continued smoking during therapy had significantly higher decline in several aspects of HRQOL, compared to patients who stopped smoking. ConclusionsHRQOL declined with substantial magnitude in patients undergoing radiation treatment for head and neck cancer, but smoking cessation may modify the declining quality of life.

P0041 The role of the radiotherapy technologist in quality of life scores in patients with head and neck cancer on radical chemoradiotherapy: A pilot study

Background Cancer and its subsequent treatment may cause physical, emotional, and psychological difficulties for individuals. Quality of life (QoL) indices are as important as the traditional end points of overall survival, disease-free survival, and tumour response in cancer management. QoL is particularly relevant for patients with head and neck cancer because social interaction and emotional expression depend to a great extent on the structural and functional integrity of the head and neck region. Methods During the period June, 2012, to June, 2013, 33 patients with head and neck squamous cell carcinoma who received radical chemoradiotherapy were prospectively assessed for QoL score using the European Organization for Research and Treatment of Cancer (EORTC) core Questionnaires version 3 (QLQ-C30) and the EORTC QLQ-H & N35, in any one of three languages (English, Hindi, Bengali). The score was assessed before the start of radical treatment, just after completion of radical treatment, and at the time of first follow up (latter not included in this report). Questionnaires were served by both nursing staff and radiotherapy technologists. QoL scores before and at completion of treatment were compared using paired t -tests. Findings There was significant improvement at treatment completion in emotional function ( p = 0.04), social function ( p = 0.05), and insomnia ( p = 0.03), and significant deterioration in appetite ( p = 0.001), nausea/vomiting ( p = 0.002), pain ( p = 0.012), swallowing ( p = 0.002), dry mouth ( p = 0.033), sticky saliva (p = 0.003), taste sensation ( p = 0.001), cough ( p = 0.004), speech ( p = 0.002), feeling ill ( p = 0.00), social contact ( p = 0.005), social eating ( p = 0.001), and using painkillers ( p = 0.03). There was no significant difference in Global QoL scores. Interpretation Radiotherapy technologists can be involved not only with treatment delivery but also with the process of assessment of QoL data in patients with head and neck cancer, and can serve as an interface between the patient and the clinician, for the holistic care of the patients on radiotherapy.

Validation of the Mexican Spanish Version of the EORTC QLQ-H&amp;N35 Instrument to Measure Health-related Quality of Life in Patients with Head and Neck Cancers

Health-related quality of life (HRQL) is an important outcome measurement in oncology. Our aim was to validate the Mexican Spanish version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H&N35 questionnaire to measure HRQL in patients with head and neck cancers. The QLQ-C30 and QLQ-H&N35 instruments were applied to Mexican patients with head and neck cancer at a cancer referral center. Reliability and validity tests were performed. Test-retest was carried out in selected patients. One hundred ninety-three patients were included in this cohort; tumor locations included the following: oral cavity 45 (23.3 %); larynx 35 (18.1 %); thyroid carcinoma invasive to aerodigestive tract 32 (16.6 %); oropharynx 17 (8.8 %); hypopharynx 12 (6.2 %); nasal cavity and paranasal sinuses 11 (5.7 %); salivary glands 11 (5.7 %); nasopharynx 8 (4.1 %); eye and adnexa 7 (3.6 %); cervical metastases of unknown origin 5 (2.6 %); primary sarcoma of the head and neck region 5 (2.6 %); maxillary antrum carcinoma 4 (2.1 %); and retinoblastoma 1 (0.5 %). Questionnaire compliance rates were high, and the instrument was well accepted; the internal consistency tests demonstrated good convergent and divergent validity. Cronbach's α coefficients of 8 of 9 multi-item scales of the QLQ-C30 and 6 of 8 scales of the QLQ-H&N35 instruments were >0.7 (range 0.22-0.89). Scales of the QLQ-C30 and QLQ-H&N35 instruments distinguished among clinically distinct groups of patients; some were highly sensitive to change over time. The Mexican Spanish version of the QLQ-H&N35 questionnaire is reliable and valid for the assessment of HRQL in patients with head and neck cancers and can be used in clinical trials in Mexican communities.

Quality of life in patients with head and neck cancer receiving targeted or multimodal therapy — Update of the EORTC QLQ‐H&amp;N35, Phase I

The objective of this study was to identify relevant quality of life (QOL) issues in patients with head and neck cancer receiving multimodal and/or targeted therapies. The literature was searched for QOL issues reported after multimodal and/or targeted therapies resulting in a list of potentially relevant issues. These were discussed within a multiprofessional expert group, revised, and subsequently rated for relevance by patients and health care providers. Twenty-seven issues were extracted that are not covered by the current version of the European Organization for Research and Treatment of Cancer (EORTC) questionnaires. Interviews (96 health care providers from 13 countries, 137 patients from 8 countries) revealed that 26 of these issues were relevant for patients with head and neck cancer. Studies investigating targeted and/or multimodal therapy should consider that some QOL issues specific to these treatments are not covered by the current version of the EORTC instruments. Consequently, the EORTC head and neck cancer module is currently in revision.

Aktuelle Entwicklungen bei der Erfassung der Lebensqualität mit Instrumenten der European Organisation for Research and Treatment of Cancer (EORTC)*

Since many years, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group develops and validates measures for the assessment of quality of life in cancer patients, using high standards of methodology. These questionnaires are meant to be used primarily in clinical trials.As treatment strategies are changing and because of some -methodological criticism, the head and neck module EORTC QLQ-H&N35 is currently being revised and updated.In this paper, we will present the current state of work and other recent developments regarding the EORTC Quality of Life questionnaire development.

English

This study compared the health-related quality of life (HRQoL) outcomes for patients with nasopharyngeal carcinoma (NPC) treated by step-and-shoot intensity-modulated radiotherapy (SaS-IMRT) versus helical tomotherapy (HT). Data from one-forty-two NPC patients consecutively treated at the same institute between March 2006 and December 2009 were collected and analysed. They received either SaS-IMRT (case number = 62) or HT (case number = 80) for their nasopharyngeal tumours and neck lymphatics. Health-related Quality of life was assessed by the European organization for research and treatment of cancer (EORTC) QLQ-C30 and the EORTC QLQ-H&amp;N35 questionnaires at the time point of 6 months after RT. A two-tailed Wilcoxon matched pair signed-rank test was used to compare the mean scores between the two groups, and the linear regression model was applied for multivariate analysis. Patient characteristics were evenly distributed between the groups. Univariate analysis found that patients in the HT group had a significantly better HRQoL in the aspects of pain, swallowing, speech, social eating, teeth, sticky saliva, and feeling ill; and a marginal significance of fewer sensation changes in the HT group. Multivariate analysis further disclosed that patients with HT had significantly fewer complaints of swallowing, senses, and feeling ill.&nbsp; Compared with SaS-IMRT, HT may provide a significantly better HRQoL in the aspects of swallowing, senses, and feeling ill. This could be explained by the further reduction of treatment-related toxicity via well-designed HT. &nbsp; Key words:&nbsp;Health-related quality of life, nasopharyngeal carcinoma, intensity-modulated radiotherapy, helical tomotherapy, EORTC.