Moral Distress in Radiation Oncology: Insights From Residents in Germany.

Purpose: Being challenged by circumstances that force one to act in discordance with one's moral compass can lead to moral distress. The phenomenon has been widely investigated among nurses. This study was designed to shed some light on the situation of resident physicians in radiation oncology. Methods and Materials: To gain insight into moral distress among residents in radiation oncology, a web-based questionnaire was developed and distributed throughout Germany. Participants were asked to evaluate possible burdensome situations and different options for relief. To outline the main issues of moral distress, an exploratory factor analysis was conducted. Relief options were examined by frequencies. Results: The factor analysis yielded lack of time, contradiction between patient request and indication, nonmedical interests, and decisions between curative treatment and best supportive care as main issues for the 84 participants. Support from supervisors and senior physicians, as well as exchanges with resident colleagues were indicated as forms of relief. Professional support, such as ethics consultations, structured conversation groups (Balint), or psychological case supervisions, were rated as less helpful, although most participants reported a lack of experience with these. Conclusions: The results are in accordance with existing assumptions that moral distress among physicians is mainly due to uncertainty. Regarding radiation oncology residents in particular, moral distress seems to be related to uncertainty in decisions and conflicts about treatment options. Although senior physicians and supervisors present important role models in dealing with moral distress, professional services such as ethics consultations offer an opportunity for relief that can still be expanded.

Teaching communication skills in medical education : Best practice example of an interdisciplinary seminar in radiation oncology.

BACKGROUND: Communication with patients is challenging, especially in radiation oncology. Therefore, radiation oncology is particularly suited to sensitize medical students for this topic and to train them competently. We report on experiences with an innovative teaching project for fourth- and fifth-year medical students. MATERIALS AND METHODS: The course, funded as an innovative teaching project by the medical faculty, was offered as an optional course for medical students in 2019 and again in 2022 after a pandemic-related break. The curriculum and evaluation form were developed through a two-stage Delphi process. The course consisted of, first, participation during counselling of patients prior to radiotherapy, mainly on topics with shared decision-making, and, second, a 1-week interdisciplinary block seminar with practical exercises. The topics covered a broad spectrum of the competence areas defined in the National Competence-Based Learning Objectives Catalog for Medicine (NKLM). The number of participants was limited to approximately 15 students because of the practical components. RESULTS: So far, 30 students (all at least in the seventh semester or higher) have participated in the teaching project. The most frequent reasons for participation were the desire to acquire competence in breaking bad news and confidence in talking to patients. The overall evaluation of the course was very positive, with a grade of 1.08 + 0.28 (on a scale of 1 = totally agree to 5 = totally disagree) plus German grade 1 (very good) to 6 (very bad). Notably, participants' expectations regarding specific competencies (e.g., breaking bad news) were also met. CONCLUSION: Although the evaluation results cannot be generalized to the entirety of medical students due to the limited number of voluntary participants, the very positive evaluation shows the need for such projects among students and can also be seen as an indication that radiation oncology as a patient-centered discipline is particularly well suited to teach medical communication.

The impact of palliative radiotherapy on health-related quality of life in patients with head and neck cancer - Results of a multicenter prospective cohort study.

Purpose: Palliative radiotherapy for patients with head and neck cancer can be used to alleviate symptoms. Only a few studies have investigated its impact on patient-reported outcomes (PRO). Therefore, we conducted a prospective multicenter observational study. The primary objective was to assess changes in health-related quality of life (HrQoL) per PRO. Methods: Eligibility criteria included i.) head and neck cancer and ii.) palliative radiotherapy indicated (EQD2Gy < 60 Gy). The primary follow-up date was eight weeks after radiotherapy (t8w). PRO measures included the EORTC QLQ-C30 and EORTC QLQ-H&N43 and pain per Numeric Rating Scale (NRS). Per protocol, five PRO domains were to be reported in detail as well as PRO domains corresponding to a primary and secondary symptom as determined by the individual patient. We defined a minimal important difference (MID) of 10 points. Results: From 06/2020 to 06/2022, 61 patients were screened and 21 patients were included. Due to death or decline in health-status, HrQoL data was available for 18 patients at the first fraction and for eight patients at t8w. The MID was not met for the predefined domains in terms of mean values as compared from first fraction to t8w. Individually in those patients with available HrQoL data at t8w, 71% (5/7) improved in their primary and 40% (2/5) in their secondary symptom domain reaching the MID from first fraction to t8w, respectively. There was a significant improvement in pain per NRS in those patients with available data at t8w per Wilcoxon signed rank test (p = 0.041). Acute mucositis of grade ≥3 per CTCAE v5.0 occurred in 44% (8/18) of the patients. The median overall survival was 11 months. Conclusion: Despite low patient numbers and risk of selection bias, our study shows some evidence of a benefit from palliative radiotherapy for head and neck cancer as measured by PRO.German Clinical Trial Registry identifier: DRKS00021197.

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy: A Systematic Review.

Importance: Approximately 50% of all patients with cancer have an indication for radiotherapy, and approximately 50% of radiotherapy is delivered with palliative intent, with the aim of alleviating symptoms. Symptoms are best assessed by patient-reported outcomes (PROs), yet their reliable interpretation requires adequate reporting in publications. Objective: To investigate the use and reporting of PROs in clinical trials of palliative radiotherapy. Evidence Review: This preregistered systematic review searched PubMed/Medline, EMBASE, and the Cochrane Center Register of Controlled Trials for clinical trials of palliative radiotherapy published from 1990 to 2020. Key eligibility criteria were palliative setting, palliative radiotherapy as treatment modality, and clinical trial design (per National Institutes of Health definition). Two authors independently assessed eligibility. Trial characteristics were extracted and standard of PRO reporting was assessed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. The association of the year of publication with the use of PROs was assessed by logistic regression. Factors associated with higher CONSORT-PRO adherence were analyzed by multiple regression. This study is reported following the PRISMA guidelines. Findings: Among 7377 records screened, 225 published clinical trials representing 24 281 patients were eligible. Of these, 45 trials (20%) used a PRO as a primary end point and 71 trials (31%) used a PRO as a secondary end point. The most prevalent PRO measures were the Numeric Rating Scale/Visual Analogue Scale (38 trials), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (32 trials), and trial-specific unvalidated measures (25 trials). A more recent year of publication was significantly associated with a higher chance of PROs as a secondary end point (odds ratio [OR], 1.04 [95% CI, 1.00-1.07]; P = .03) but not as primary end point. Adherence to CONSORT-PRO was poor or moderate for most items. Mean (SD) adherence to the extension adherence score was 46.2% (19.6%) for trials with PROs as primary end point and 31.8% (19.8%) for trials with PROs as a secondary end point. PROs as a primary end point (regression coefficient, 9.755 [95% CI, 2.270-17.240]; P = .01), brachytherapy as radiotherapy modality (regression coefficient, 16.795 [95% CI, 5.840-27.751]; P = .003), and larger sample size (regression coefficient, 0.028 [95% CI, 0.006-0.049]; P = .01) were significantly associated with better PRO reporting per extension adherence score. Conclusions and Relevance: In this systematic review of palliative radiotherapy trials, the use and reporting of PROs had room for improvement for future trials, preferably with PROs as a primary end point.

Clinical endpoints in trials of palliative radiotherapy: A systematic meta-research analysis.

PURPOSE: Up to 50% of radiotherapy courses are delivered in palliative intent for various indications. Despite the large number of treated patients, we know little about the choice of endpoints in trials of palliative radiotherapy. Our primary aim was, therefore, to analyze primary endpoints in trials of palliative radiotherapy. METHODS: We conducted a pre-registered (https://doi.org/10.17605/OSF.IO/GMCAF) meta-research analysis searching Pubmed/MEDLINE, EMBASE, CENTRAL, and "ClinicalTrials.gov" for clinical trials of palliative radiotherapy published 1990-2020. Endpoints were categorized in "patient-centered endpoints", including overall survival and patient-reported outcomes, and "tumor-centered endpoints" such as local control. The remainder were "other endpoints" including toxicity or observer-rated symptoms. We applied descriptive statistics to summarize data and logistic regression to assess if year of publication predicted the choice of primary endpoints. RESULTS: Of 7379 records screened, 292 were eligible. Trials were characterized by small sample sizes and use of external beam radiotherapy for metastases or thoracic primaries. Median patient age was 64 and median ECOG was 1. Only 64.4%(145/225) of published trials clearly stated their primary endpoint. Published trials employed a "patient-centered primary endpoint" in 45.5%(66/145) and a "tumor-centered primary endpoint" in 17.3%(25/145) of the cases. There was no statistically significant trend in time for the use of "patient-centered primary endpoints". Registered ongoing trials used a "patient-centered primary endpoint" in 32.8%(22/67) and a "tumor-centered primary endpoint" in 26.9%(18/67) of the cases. CONCLUSION: Although "patient-centered primary endpoints" appear relatively prevalent in published trials of palliative radiotherapy, their use is still suboptimal and appears to be lower in currently ongoing trials.

Transparent entscheiden im moralischen Dilemma: Ethische Entscheidungsempfehlungen zu Besuchsregelungen im Krankenhaus während der COVID-19-Pandemie.

Visitation restrictions in hospitals during the COVID-19 (coronavirus disease 2019) pandemic led to great psychological burden for patients, their relatives and employees. For hospitals, they represent a complex organizational challenge with respect to ethics. The present recommendations are intended to support decision-making at the meso- and microlevels.

Cause of Death in Patients in Radiation Oncology.

BACKGROUND: The accurate attribution of death in oncologic patients is a difficult task. The patient's death is often attributed to his or her underlying cancer and therefore judged as cancer-related. We hypothesized that even though our patient's cancers were either advanced or metastatic, not all patients had died simply because of their cancer. METHODS: A total of 105 patients were included in this retrospective analysis. Patient data were collected from digital and paper-based records. Cause of death was assessed from death certificate and compared to the medical autopsy reports. Discrepancies between premortem and postmortem diagnoses were classified as class I and II discrepancies. RESULTS: Of 105 patients included, autopsy consent was obtained in 56 cases (53%). Among them, 32 of 56 were palliatively sedated, and 42/56 patients died cancer-related as confirmed by autopsy. The most common cause of death by autopsy report was multiorgan failure followed by a combination of tumor and infection, predominantly lung cancer with pneumonia. Here, 21/56 cases (37%) showed major missed diagnoses: seven cases showed class I, 10 class II, and both discrepancies. The most commonly missed diagnoses in both categories were infections, again mainly pneumonia. CONCLUSIONS: Cancer was the leading cause of death in our study population. A quarter of the patients, however, did not die due to their advanced or metastatic cancers but of potentially curable causes. We therefore conclude that it is important to consider competing causes of death when treating palliative cancer patients. In a palliative setting, the treatment of a potentially curable complication should be discussed with the patients and their families in a shared decision-making process. From our experience, many patients will decline treatment or even further diagnostics when given the option of best supportive care.

Psychometric validation of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Sexual Health (EORTC QLQ-SH22).

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire. METHODS: The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures. RESULTS: The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender-specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale, .80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from .70 to .93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status. CONCLUSION: The study supports the reliability, the content and construct validity of the QLQ-SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice.

Patient-Reported Outcomes Assessing the Impact of Palliative Radiotherapy on Quality of Life and Symptom Burden in Head and Neck Cancer Patients: A Systematic Review.

Incurable head and neck cancer has a poor prognosis and impairs a patient's health-related quality of life. Palliative radiotherapy may improve or stabilize health-related quality of life and symptoms, best measured by patient-reported outcomes. There is no systematic analysis if palliative radiotherapy for head and neck cancer improves or stabilizes health-related quality of life or symptoms as validly measured by patient-reported outcomes. Therefore, the primary objective of this systematic review (PROSPERO-ID: CRD42020166434) was to assess the effect of palliative radiotherapy for head and neck cancer on patient-reported outcomes. The secondary objective was to assess the rate and quality of use of patient-reported outcomes in relevant studies claiming a "palliative effect" of radiotherapy. The databases MEDLINE/PubMed, EMBASE, Cochrane CENTRAL, "ClinicalTrials.gov" were searched. Concerning the primary objective, four studies were eligible to assess the effectiveness of palliative radiotherapy as measured by patient-reported outcomes. A narrative synthesis suggests a favorable impact of palliative radiotherapy on health-related quality of life and symptom burden. The risk of bias, however, is considerable and the overall quality of evidence low. Concerning the secondary objective, over 90% of studies claiming a "palliative effect" of palliative radiotherapy did either not use patient-reported outcomes or did so by limited quality. In conclusion, implementation of patient-reported outcomes in studies assessing palliative radiotherapy for head and neck cancer should be fostered. Palliative radiotherapy remains an option for head and neck cancer patients, although more studies focusing on patient-reported outcomes are needed. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/, identifier CRD42020166434.

[Recommendations for ethical decision making regarding hospital visitation during the COVID-19 pandemic]. / Ethische Entscheidungsempfehlungen zu Besuchsregelungen im Krankenhaus während der COVID-19-Pandemie.

Visitation restrictions in hospitals during the COVID-19 (coronavirus disease 2019) pandemic led to great psychological burden for patients, their relatives and employees. For hospitals, they represent a complex organizational challenge with respect to ethics. The present recommendations are intended to support decision-making at the meso- and microlevels.

Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients with Oligometastatic Breast Cancer: Study protocol for a randomized controlled multi-national and multi-center clinical trial (OLIGOMA).

BACKGROUND: Several recent randomized therapeutic exploratory trials demonstrated improvement of progression-free survival and in some even overall survival using stereotactic body radiotherapy in patients with oligometastatic disease. However, only very few patients enrolled in these trials had breast cancer, and results from confirmatory trials are lacking. METHODS/DESIGN: The OLIGOMA-trial is a randomized controlled multi-national multi-center therapeutic confirmatory trial studying the role of local ablative radiotherapy as an additive treatment in patients with oligometastatic breast cancer receiving standard systemic therapy. Patients will be randomized 1:1 to standard systemic therapy according to national guidelines with or without radiotherapy to all metastatic sites. Randomization will be stratified according to type and line of systemic therapy, which has to be determined by a multidisciplinary tumor board before enrollment. Patients with up to five metastatic lesions are eligible, including patients with up to three brain metastases (only in case of extracranial disease) and with locoregional recurrence (only in case of additional metastatic lesions). In the standard arm, palliative radiotherapy to symptomatic metastases is permitted if at least one lesion remains untreated. The co-primary endpoints are progression-free survival and quality of life. The primary hypothesis is that progression-free survival in the experimental arm will be superior to the standard arm while simultaneously demonstrating non-inferiority of quality of life at 12 weeks after randomization. Secondary endpoints are feasibility, overall survival, toxicity, quality of life and patient satisfaction. A translational sub-study with collection of ctDNA will be conducted. DISCUSSION: The OLIGOMA-trial will provide high level evidence on the use of and benefit from local ablative radiotherapy for patients with oligometastatic breast cancer. TRIAL REGISTRATION: The OLIGOMA-trial is registered at clinicialtrials.gov under the identification NCT04495309. The related information was first posted on July 31st 2020.

International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV.

BACKGROUND: We validated the new European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43). METHODS: We enrolled 812 patients with head and neck cancer from 18 countries. Group 1 completed the questionnaire before therapy, and 3 and 6 months later. In group 2 (survivors), we determined test-retest reliability using intraclass correlation coefficients (ICC). Internal consistency was assessed using Cronbach's Alpha, the scale structure with confirmatory factor analysis, and discriminant validity with known-group comparisons. RESULTS: Cronbach's alpha was >0.70 in 10 of the 12 multi-item scales. All standardized factor loadings exceeded 0.40. The ICC was >0.70 in all but two scales. Differences in scale scores between known-groups were >10 points in 17 of the 19 scales. Sensitivity to change was found to be sufficient in 18 scales. CONCLUSIONS: Evidence supports the reliability and validity of the EORTC QLQ-HN43 as a measure of quality of life.

Transoral Laser Microsurgery for Supraglottic Cancer.

INTRODUCTION: Transoral laser microsurgery (TLM) is an accepted and effective treatment strategy for supraglottic carcinomas. Early supraglottic carcinoma has excellent outcomes independently of the treatment approach. The role of TLM for the treatment of locally advanced tumors is debated. Particularly, the functional outcomes after TLM have to be proven by functional assessment of large cohorts of patients. This study analyzes the oncologic and functional outcomes after TLM for supraglottic carcinomas. PATIENTS AND METHODS: Ninety-one patients with pT1-pT4a supraglottic carcinomas treated between January 2002 and December 2012 were analyzed. Distribution of tumors (UICC 2010) was 11 patients with pT1, 31 patients with pT2, 36 patients with pT3, and 13 patients with pT4a tumors. Node status was positive in 40 (43.6%) patients; 61 (67.1%) patients had stage III or IVa disease. Local control and survival were estimated using the Kaplan-Meier method. For the assessment of functional outcomes, the MD Anderson Dysphagia Inventory (MDADI), the Voice Handicap Index-10 (VHI-10), and the performance status scale for head and neck cancer [Performance Status Scale for Head and Neck (PSS-HN)] were used. RESULTS: The median age was 62 years (range, 33-88 years). Fourteen (15.4%) patients developed a local or locoregional recurrence. The 5-year local control rate and 5-year ultimate local control rate were 72 and 92%, respectively. The 5-year overall survival rate was 63%. Twelve (13.2%) patients needed temporary tracheostomy. Sixty-eight (74.0%) patients had a nasogastric feeding tube post-operatively. At 1-year post-operative follow-up, only three patients were PEG dependent. The median VHI-10 score was 35, the median MDADI composite score was 80, and the median score of the domain "normalcy of diet" in the PSS-HN was 91. CONCLUSION: The oncologic outcomes are comparable to the results of open surgery for early and advanced supraglottic carcinomas. Functional swallowing outcome is superior to open surgery and to concomitant chemoradiation. Patients treated with TLM perceive low levels of voice- and swallowing-related quality of life impairment.

Phase 1-3 of the cross-cultural development of an EORTC questionnaire for the assessment of sexual health in cancer patients: the EORTC SHQ-22.

To develop and pretest an European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire (EORTC SHQ-22) for the assessment of physical, psychological, and social aspects of sexual health (SH) in male and female cancer patients and survivors. Questionnaire construction started with creating a list of relevant SH issues based on a comprehensive literature review. Issues were subsequently evaluated for relevance and prioritization by 78 healthcare professionals (HCP) and 107 patients from 12 countries during in-depth interviews (phase 1). Extracted issues were operationalized into items (phase 2). Phase 3 focused on pretesting the preliminary questionnaire in a cross-cultural patient sample (n = 171) using debriefing interviews. Psychometric properties were preliminary determined using a principal component analysis and Cronbach's alpha. We derived 53 relevant SH issues from the literature. Based on HCP and patient interviews, 22 of these 53 issues were selected and operationalized into items. Testing the preliminary 22-item short questionnaire resulted in a change of wording in five items and two communication-related items; no items were removed. Preliminary psychometric analysis revealed a two-factor solution and 11 single items; both scales showed good reliability indicated by a Cronbach's alpha of 0.87 (sexual satisfaction) and 0.82 (sexual pain). Cross-cultural pretesting of the preliminary EORTC SH questionnaire has indicated excellent applicability, patient acceptance, and comprehensiveness as well as good psychometric properties. The final development phase, that is psychometric validation (phase four) including large-scale, cross-cultural field testing of the EORTC SHQ-22, has commenced.

Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review.

OBJECTIVES: Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures (PROMs) are increasingly used when evaluating disease- and treatment-specific effects. However, the adequacy of measures used to assess sequelae and QoL in VC remains unclear. The aims of the present study were to evaluate disease- and treatment-related effects as measured by PROMs in VC patients and to identify available VC-specific PROMs. METHODS/MATERIALS: A systematic literature search from 1990 to 2016 was performed. The inclusion criterion was report of disease- and treatment-related effects in VC patients using PROMs in the assessment. Methodological and reporting quality was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review was performed as part of phase 1 of the development of a European Organisation for Research and Treatment of Cancer QoL questionnaire for VC patients. RESULTS: The search revealed 2299 relevant hits, with 11 articles extracted including a total of 535 women with VC; no randomized controlled trials were identified. The selected studies exhibited great heterogeneity in terms of PROMs use. Twenty-one different instruments assessed QoL. Most of the questionnaires were generic. Different issues (sexuality, lymphedema, body image, urinary and bowel function, vulva-specific symptoms) were reported as potentially important, but the results were not systematically collected. Only one VC-specific questionnaire was identified but did not allow for assessment and reporting on a scale level. CONCLUSIONS: Vulva cancer treatment is associated with considerable morbidity deteriorating QoL. To date, there is no validated PROM available that provides adequate coverage of VC-related issues. The study confirms the need for a VC-specific QoL instrument with sensitive scales that allows for broad cross-cultural application for use in clinical trials.

Measuring quality of life in patients with head and neck cancer: Update of the EORTC QLQ-H&N Module, Phase III.

BACKGROUND: The objective of this study was to pilot test an updated version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H&N60). METHODS: Patients with head and neck cancer were asked to complete a list of 60 head and neck cancer-specific items comprising the updated EORTC head and neck module and the core questionnaire EORTC QLQ-C30. Debriefing interviews were conducted to identify any irrelevant items and confusing or upsetting wording. RESULTS: Interviews were performed with 330 patients from 17 countries, representing different head and neck cancer sites and treatments. Forty-one of the 60 items were retained according to the predefined EORTC criteria for module development, for another 2 items the wording was refined, and 17 items were removed. CONCLUSION: The preliminary EORTC QLQ-H&N43 can now be used in academic research. Psychometrics will be tested in a larger field study.

Quality of life in patients with head and neck cancer receiving targeted or multimodal therapy--update of the EORTC QLQ-H&N35, Phase I.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.